Hospice & Palliative Medicine

A diagnosis of cancer, its treatment, and surveillance are fraught with distress. Distress is defined by the National Comprehensive Cancer Network^® (NCCN^®) as “a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms, and its treatment.”¹ Distress is known to occur at any point along the cancer-disease trajectory: during diagnosis, during treatment, at the end of treatment, at pivotal treatment decision points, from survivorship through to end of life.² The severity of the distress can range from “common normal feelings of vulnerability, sadness, and fears to problems that can become disabling, such as depression, anxiety, panic, social isolation, and existential and spiritual crisis.”¹ Most important, the impact of distress has been associated with reduced quality of life (QOL) and potentially reduced survival.^3,4

About 33% of all persons with cancer experience severe distress.^5,6 As a result of the prevalence and severity of distress, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management recommend that all patients with cancer should be screened for distress, using a standardized tool, at their initial visit, at appropriate intervals, and as clinically indicated.¹ The time line for longitudinal screening of “appropriate intervals” has not been firmly established.² However, it is well recognized that appropriate intervals include times of vulnerability such as remission, recurrence, termination of treatment, and progression.^1,7 Despite efforts to improve distress screening and intervention, many institutions struggle to adhere to the NCCN Guidelines®.^8,9

In 2012, the American College of Surgeons Commission on Cancer (ACoS CoC) identified distress screening as an essential accreditation standard by 2015.¹⁰ The standard mandates that patients be screened a minimum of 1 time at a “pivotal” medical visit (such as time of diagnosis, transitions in cancer treatment, recurrence, completion of cancer treatment, and progression of disease). In practice, most institutions typically screen at diagnosis.² According to the ACoS CoC, 41 VAMCs are accredited sites that will be impacted by the implementation of this standard.¹⁰

Distress Screening Tools

A major challenge and barrier to integrating distress screening in cancer clinics is the lack of consensus on the best measurement tool in a busy ambulatory clinic. Although a number of screening tools are available for measuring cancer-related distress, they vary in efficacy and feasibility. According to Zabora and Macmurray, the perfect screening instrument for distress in persons with cancer does not exist.6 Brief screening tools demonstrate high sensitivity in identifying very distressed patients but lack specificity, resulting in false positives.^8,11 More extensive screening instruments, such as the Hospital Anxiety and Depression Scale (HADS), the Brief Symptom Inventory (BSI)-18, and the Psycho-Oncology Screening Tool (POST), have lower rates of false positives but may be more burdensome for providers, especially when considering copyright and cost.⁶

Ambulatory cancer care requires a rapid screening method with high sensitivity and minimal burden.¹² The NCCN Distress Thermometer (DT) has face validity and allows for rapid screening; however, its psychometric properties are not as robust as other instru ments, such as the Center for Epidemiological Studies Depression Scale, the Hospital Anxiety and Depression Scale, Psychological Distress Inventory, or Brief Symptom Inventory.¹³ Although the DT has been shown to identify clinically significant anxiety, it is not as sensitive in identifying depression.⁴

The NCCN DT has 2 parts to the screening: (1) an overall distressintensity score within the past week, including the current day; and (2) an accompanying problem list, grouped into 5 categories, addressing QOL domains.¹⁴ The quantitative score ranges from 0 (no distress) to 10 (extreme distress). The problem list complements the quantitative score by providing information about the source of distress and can help to tailor the intervention (Figure 1). Access to the NCCN Guideline and DT is free for clinical and personal use.

According to the NCCN Guideline, scores of ≥ 4 require distress-management intervention.¹ Mild distress (score < 4) usually can be managed by the primary oncology team.¹⁵ However, if the patient’s score is moderate (4-7) or severe (8-10), urgent intervention is necessary. Depending on the source of the distress, the patient should be seen by the appropriate discipline. For patients with practical problems, such as transportation, finances, and housing issues, a referral to social work is needed. For those with distress related to mental health issues, psychology, psychiatry, or social work may be appropriate.

Patients with distressing physical symptoms should be seen by the physician or advanced practice registered nurse (APRN) from the oncology or palliative care team. With limited psychosocial resources available at many cancer clinics, identification and triage for those with the highest levels of distress are critical.⁵ Triage must incorporate both the total distress score and the components of the distress so that the appropriate disciplines are accessed for the plan of care. More than one discipline may be needed to address multifactorial distress.

Despite strong recommendations from NCCN, ACoS, and many other professional and accrediting agencies, numerous cancer programs face challenges implementing routine screening. This article reports on a large, inner city ambulatory clinic’s pilot project to distress screen all patients at every appointment in the Cancer Center of Excellence (CoE) at Louis Stokes Cleveland VAMC (LSCVAMC) between May 2012 and May 2014 and to provide immediate intervention from the appropriate discipline for patients scoring ≥ 4 on a 0 to 10 DT scale. Results of the screenings, feasibility of screening in an ambulatory VA cancer clinic, and impact on psychosocial resources are presented.

Center of Excellence Project

The LSCVAMC CoE Cancer Care Clinic began as a 3-year grant-funded project from the VA Offices of Specialty Care and Academic Affiliations with 2 major objectives: (1) to deliver quality patient-centered cancer care as measured by implementation of a process for distress screening and management, and development and implementation of a survivorship care plan for patients who have completed cancer treatment; and (2) to provide interprofessional education for the interdisciplinary health care professionals who participate in the clinic as part of their training experience.

Patients in this unique CoE cancer clinic have sameday access to all members of the interdisciplinary and interprofessional team. The ambulatory cancer care CoE team was originally composed of a surgical oncologist, a medical oncologist, a clinical nurse specialist (CNS) patient navigator, a nurse practitioner (NP) in survivorship care, a registered nurse (RN), a psychologist, and an oncology social worker. The project’s patient population included patients with a cancer concern (positive family history and suspicious scans) or a diagnosis of breast cancer, melanoma, sarcoma, or hematologic malignancies. The patient population for the project was based on the CoE team expertise and feasibility of implementation, with plans to roll out the model of care for all patients with any cancer diagnosis across the VAMC at the completion of the project.

The CoE made distress screening and management the leading priority for quality patient-centered care at the start of the project. The purpose of this emphasis on distress screening was to develop a process at LSCVAMC that would meet the 2015 CoC standards and to teach health care professional trainees (NP students, residents, social work students, and fellows in psychology and medical oncology) about distress screening and intervention.

A plan-do-act model of quality improvement (QI) was used to support the development and implementation of the distress-screening process. At the beginning of the project, the institutional review board (IRB) reviewed the protocol and determined that informed consent was not necessary because a QI project for a new standard of care did not require IRB approval. The CoE team met for about 4 months to develop a policy and procedure for the process, based on evidence from national guidelines, a review of the literature, and a discussion of the benefits and burdens of implementation within the current practice.

Limiting initial implementation to a single clinic day made the process more manageable. Descriptive methods analyzed the incidence and percentage of overall distress in this veteran population and quantified the incidences and percentages of each DT component. Feedback from patients and staff offered information on the feasibility of and satisfaction with the process.

From May 2012 to May 2014, all patients who attended the Monday outpatient CoE clinic with a diagnosis of cancer or a cancer concern were given the NCCN, 2.2013 DT instrument by the registration desk clerk at the time they registered for their clinic appointment. ¹⁶ Veterans who had difficulty filling out the DT or who had diminished capacity were assisted in completing the instrument by a designated family member and/or the clinic RN.

The completed instrument was evaluated by the CNS patient navigator, and any patient with a score ≥ 4 received an automatic referral to the behavioral health psychologist, social worker, NP, or all team members and their trainees, depending on the areas of distress (eg, practical, family, and emotional problems, spiritual/religious concerns, and/or physical problems) endorsed by the patient.

A psychiatrist was not embedded into the team but worked closely with the team’s oncology psychologist. The psychologist communicated directly with the psychiatrist, and the plan was shared with the team through the electronic medical record (EMR). The appropriate team member(s) and trainee(s) saw the patient at the visit to address needs in real time. Access to palliative care support and spiritual care was readily available if needed.

Distress screenings were recorded in a templated note in the patient’s EMR, which allowed the team to follow the distress scores on an individual basis across the cancer disease trajectory and to assess response to interventions. Multiple screenings of individuals resulted from the fact that many of the patients were seen monthly or every 3/6/9 months, depending on their disease and treatment status. Because levels of distress can fluctuate, distress was assessed at every visit to determine whether an intervention was needed at that visit. Once distress screenings were recorded in the patient’s EMR, the DT instrument was de-identified and given to the CoE research consultant to enter into a database file for analysis.

Trainees were educated about the use of the DT at time of diagnosis and across the disease trajectory. The 4-week CoE curriculum included 2 weeks of conference time to teach about the roles of psychologist, oncology social worker, and survivorship NP in assessing and initiating interventions to address the multidimensional components of the DT. Trainees working with a veteran who was distressed participated in the assessment(s) and intervention(s) for all components of distress that were endorsed.

Results

A total of 866 distress screenings were performed during the first 2 years of the project. Since all patients were screened at all visits, the 866 distress screenings reflect multiple screenings for 445 unique patients. Of the 866 screenings, 290 (33%) had distress scores of ≥ 4, meeting the criteria for intervention. Screenings reflected patient visits at any point in the disease trajectory. Because this was a new standard of care QI project rather than a research project, additional data, such as diagnosis or staging, were not collected, and IRB approval was not needed.

Because the NCCN Guideline recommendation for intervention is a score of ≥ 4, the descriptive statistics focused on those with moderate-to-severe distress. However, there were numerous occasions when the veteran would report a score of 0 to 3 and still endorse a number of the problems on the DT. The CNS and RN on the team discussed these findings with the appropriate discipline. For example, if the veteran reported a score of 1 but endorsed all 6 components on the emotional problem list, the nurses discussed the patient with the social worker or psychologist to determine whether behavioral health intervention was needed.

The mean distress score for the 290 screenings ≥ 4 was 6.3 on a 0 to 10 scale; median was 6.0 and mode 5.0. Two hundred ten of these screenings (72%) were categorized as moderate distress (4-7), and 80 patients (28%) reported severe distress (Figure 2). If the veteran left a box empty on the problem list, itwas recorded as missing. The frequency that patients reported each type of distress are reported in Figure 3.

The incidence of each component of distress, from those screenings with a score of ≥ 4 is described below, along with case study examples for each component. Team members involved in patient interventions provided these case studies to demonstrate clinical examples of the veteran’s distress from the problem list on the DT.

Practical/Family Distress

Practical issues were reported in 38% of the screenings (109/290). Intervention for moderate-to-severe distress associated with practical problems and family issues was provided by the team social worker. The social worker frequently addressed transportationrelated distress. Providing transportation was essential for adherence to clinic appointments, follow-up testing, treatments, and ultimately, disease management. Housing was also a problem for many veterans. It is critical that patients have access to electricity, heating, food, and water to be able to safely undergo adjuvant therapy. Thus, treatments decisions could be impacted by the veterans’ housing and transportation issues; immediate access to social work support is essential for quality cancer care.

Twenty-six percent of patients that were screened expressed concerns with practical and/or family problems (75/289). Issues of domestic violence, difficulties dealing with a significant other, and concerns about children were referred to social work (Table 1).

Case Study

Ms. S. is a veteran aged 71 years with recently diagnosed breast cancer. She is being seen in the clinic for a postoperative visit following partial mastectomy and is anticipating beginning radiation therapy within the next 3 weeks. She reports a distress score of 7 and identifies concerns about work and transportation to the clinic as the sources of distress. The social worker meets with the patient and learns that she fears losing her job because of the daily travel time to and from radiation and that she cannot afford to travel 65 miles daily to LSCVAMC for radiation. The social worker listens to her concerns and assists her with a plan for short-term disability and VA housing during her radiation therapy treatments. Ms. S. was able to complete radiation at LSCVAMC with temporary housing and to return to work after therapy.

Emotional Distress

Patients who identified that their moderate-to-severe distress was related to emotional problems received same-day intervention from a psychologist skilled in providing emotional support, cognitive behavioral strategies, and assessing the need for referral to either a psychiatrist or oncology social worker. Seventy-one percent of patients reported emotional problems, such as worry, depression, and nervousness (Table 2).

Case Study

Mr. K. is a veteran aged 71 years with a new diagnosis of breast cancer. He lives on his own but has family and a few friends nearby. He reports that he doesn’t like to share his problems with others and has not told anyone of his new diagnosis. Mr. K. rates his distress a 7 and endorses worry, fear, and depression. At a treatment-planning visit, he agrees to see the psychologist for help in dealing with his distress. Treatment involves a mastectomy followed by hormonal therapy.

Mr. K. was scared about having cancer; some of his veteran colleagues have developed cancer recently, and 2 have died. He told the psychologist that he feels worthless and that this disease just makes him more of a burden on society. He has had thoughts of taking his life so that he doesn’t have to deal with cancer, but he does not have a plan. The team formulated a plan to address his anxiety and depression. Mr. K. started a serotonin reuptake inhibitor, and he met with the VA psychiatrist weekly to help develop coping strategies. The team’s psychologist worked closely with Mr. K.’s psychiatrist, and he successfully completed surgery and chemotherapy. He is now being seen in survivorship clinic, continuing care with the team and his psychologist.

Spiritual Distress

Although spiritual/religious concerns are part of DT screening, it is only a single item on the DT. Just 8% of patients (21/276) reported moderate-to-severe spiritual distress. However, there was access to a chaplain at LSCVAMC.

Case Study

Mr. H., a 63-year-old veteran with stage IV melanoma, was seen in the clinic for severe pain in his left hip and ribs (8 on a 10-point scale); he was unresponsive to escalating doses of oxycodone. During the visit, he reported that his distress level is a 10, and in addition to identifying pain as a source of distress, he indicated that he has spiritual distress. When questioned further about spiritual distress, Mr. H. reported that he deserves this pain since he caused so many others pain during his time in Vietnam. The chaplain was contacted, and the patient was seen in clinic at this visit. The chaplain gave him the opportunity to share his feelings of guilt. The importance of spiritual care when the patient is experiencing “total pain” is essential to pain management. Within 3 days, his pain score decreased to an acceptable level of 3 with no additional pharmacologic intervention.

Physical Distress

Physical problems associated with the distress scores were addressed by the surgical and medical oncologists and the APRNs (CNS patient navigator and survivorship NP). When the clinic opened, the team used the Memorial Symptom Assessment Scale to assess physical and psychological symptoms.16 However, patients reported experiencing distress at having to complete 2 tools that had a great deal of overlap. The team determined that the DT could be used as the sole screening tool for all QOL domains.

It is important to note that 92% of patients with moderate-to-severe distress reported physical symptoms as a source of distress (Table 3).

Case Study

Ms. L. is a Vietnam War veteran aged 64 years who was seen in the survivorship clinic. She was diagnosed with estrogen-receptor (ER) and progesterone-receptor (PR) breast cancer 1 year previously, had a lumpectomy followed by radiation therapy, and was on hormonal therapy. She recorded her distress score as a 6 and indicated that multiple physical symptoms were her major concern. She had difficulty with insomnia, fatigue, and hot flashes. The survivorship NP talked with Ms. L. about her symptoms and made nonpharmacologic recommendations for improving sleep, provided an exercise plan for fatigue, and initiated venlafaxine to manage the hot flashes. Ms. L. continued to be seen by the team in survivorship clinic, and during her 3-month follow-up visit, she reported improvement in sleep as the hot flashes diminished.

Multifactoral Distress

Many patients endorsed ≥ 1 component of distress. This required a team approach to intervene for the multifactorial nature of the distress.

Case Study

Mr. K. is a veteran aged 82 years who had been a farmer most of his life. He was cared for at the VA for an advancedstage squamous cell skin cancer of his scalp, which he had allowed to go untreated. The cancer has completely eroded beneath his scalp, and he wore a hat to cover the foul-smelling wound. He lived in rural Ohio with his wife of 55 years; 3 adult daughters lived in the Cleveland area. His daughters served as primary caregivers when Mr. K. came to Cleveland for daily radiation and weekly chemotherapy treatments. He had not been away from his wife since the war and misses her terribly, returning home only on weekends during the 6-week course of radiation.

His primary goal was to return home in time to harvest his farm’s produce 2 months later. He was aware that he has < 6 months to live but wanted chemotherapy and radiation to control the growth of the cancer. During this visit to the ambulatory clinic, he reported a distress score of 5 andidentified family concerns (eg, living away from his wife most of every week) and endorsed emotional concerns of fear, worry, and sadness, and reported pain, fatigue, insomnia, and constipation as physical concerns.

Mr. K. received support from the social worker, the psychologist, and the APRN for symptom management during this visit. The social worker was able to advocate for limited palliative radiation therapy treatments rather than a 6-week course; the psychologist spent 45 minutes talking with him about his fears of a painful death, worries about his wife, and sadness at not being alive for another planting season. The APRN recommended both pharmacologic and nonpharmacologic interventions for his fatigue and insomnia and initiated a pain and bowel pharmacologic regimen. The team respected Mr. K.’s wish to reconsider hospice care at the following visit after he had talked with his wife. Mr. K. died peacefully in his home with his wife and family just before the start of planting season.

Clinical Implications

Distress screening and intervention is essential for quality cancer care. While a great deal of controversy exists about the best time to screen for distress, the LSCVAMC CoE has taken on the challenge of screening and intervening in real time at every patient visit across the disease trajectory. The model of distress screening all veterans at CoE clinic visits has been rolled out to other cancer clinics at LSCVAMC.

Distress screening at each visit is not time intensive. Patients are willing to fill out the instrument while waiting for their clinic visit, and most patients find that it takes less than 5 minutes to complete. The major challenge for institutions considering screening with each visit is not the screening but access to appropriate providers able to provide timely intervention. The success of this model results, in part, because the clinic RN assesses the responses to the DT and refers to the appropriate discipline, utilizing precious resources of social work and psychology appropriately. The VA system is already committed to improving the psychosocial well-being of veterans and has established social work and psychology resources specifically for the cancer clinics.

Many patients reported to the authors that they might not have been able or willing to return to LSCVAMC to see the behavioral health specialists on another day. In addition, scheduling behavioral health appointments at another time would not allow for attending to the distress in real time. Also, from a systems standpoint, it would have been an added cost to the VA and/or the veteran for transportation for additional appointments on different days.

Finally, although the impact of the CoE project on health professional trainees has been reported elsewhere, the distress screening and intervention process were valued as being very positive for all trainees who participated in CoE clinic.¹⁷ The trainees were able to stay with the patient for the entire clinic visit, including the visits made by disciplines other than their own. For example, the family medicine residents stayed with the patient they examined to observe the distress assessments and interventions offered by the social worker and/or psychologist for the patients who scored ≥ 4 on the DT.

At the end of their rotations in the CoE, trainees reported an increased awareness of the importance of distress screening in a cancer clinic. Many were not aware of the NCCN guidelines and the ACoS CoC mandate for distress screening as a standard of cancer care. Interdisciplinary trainees rated the CoE curriculum and the conference teaching/learning sessions on distress management highly. However, observing the role of the social worker and psychologist were the most valuable to trainees, regardless of the area of practice they enter.

Conclusion

Addressing practical, psychosocial, physical, and spiritual needs will help decrease distress, support patients’ ability to tolerate treatment, and improve veterans’ QOL across the cancer-disease trajectory. Screening all patients at an outpatient cancer clinic at LSCVAMC is feasible and does not seem to be a burden for patients or providers. This pilot project has become standard of care across the LSCVAMC cancer clinics, demonstrating its sustainability.

Screening with the DT provides information about the intensity of the distress and the components contributing to the distress. The most important aspect of the screening is assessing the components of the distress and providing real-time intervention from the appropriate discipline. It is critical that the oncology team refer to the appropriate discipline based on the source of the distress rather than on only the intensity. Findings from this project indicate that physical symptoms are frequently the source of distress and may not require behavioral health intervention. However, for patients with psychosocial needs, rapid access to behavioral health care services is critical for quality veteran-centered cancer care.

Since 2015, all VA cancer centers are required to have implemented distress screening. According to the CoC, at least 1 screening must be done on every patient.¹⁰ Many institutions have begun to screen at diagnosis, but it is well known that there are many points along the cancer trajectory when patients may experience an increase in distress. Simple screening with the DT at every cancer clinic visit helps identify the veterans’ needs at any point along the disease spectrum.

At LSCVAMC, the CoE was designed as an interdisciplinary cancer clinic. With the conclusion of funding in FY 2015, the clinic has continued to function. The rollout into other clinics has continued with movement toward use of formal consult requests and continual, real-time evaluation of the process. Work on accurate, timely identification of new cancer patients and identifying pivotal cancer visits is underway. The LSCVAMC is committed to improving care and access to its veterans with cancer to ensure appropriate and adequate services across the cancer trajectory.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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A diagnosis of cancer, its treatment, and surveillance are fraught with distress. Distress is defined by the National Comprehensive Cancer Network^® (NCCN^®) as “a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms, and its treatment.”¹ Distress is known to occur at any point along the cancer-disease trajectory: during diagnosis, during treatment, at the end of treatment, at pivotal treatment decision points, from survivorship through to end of life.² The severity of the distress can range from “common normal feelings of vulnerability, sadness, and fears to problems that can become disabling, such as depression, anxiety, panic, social isolation, and existential and spiritual crisis.”¹ Most important, the impact of distress has been associated with reduced quality of life (QOL) and potentially reduced survival.^3,4

About 33% of all persons with cancer experience severe distress.^5,6 As a result of the prevalence and severity of distress, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management recommend that all patients with cancer should be screened for distress, using a standardized tool, at their initial visit, at appropriate intervals, and as clinically indicated.¹ The time line for longitudinal screening of “appropriate intervals” has not been firmly established.² However, it is well recognized that appropriate intervals include times of vulnerability such as remission, recurrence, termination of treatment, and progression.^1,7 Despite efforts to improve distress screening and intervention, many institutions struggle to adhere to the NCCN Guidelines®.^8,9

In 2012, the American College of Surgeons Commission on Cancer (ACoS CoC) identified distress screening as an essential accreditation standard by 2015.¹⁰ The standard mandates that patients be screened a minimum of 1 time at a “pivotal” medical visit (such as time of diagnosis, transitions in cancer treatment, recurrence, completion of cancer treatment, and progression of disease). In practice, most institutions typically screen at diagnosis.² According to the ACoS CoC, 41 VAMCs are accredited sites that will be impacted by the implementation of this standard.¹⁰

Distress Screening Tools

A major challenge and barrier to integrating distress screening in cancer clinics is the lack of consensus on the best measurement tool in a busy ambulatory clinic. Although a number of screening tools are available for measuring cancer-related distress, they vary in efficacy and feasibility. According to Zabora and Macmurray, the perfect screening instrument for distress in persons with cancer does not exist.6 Brief screening tools demonstrate high sensitivity in identifying very distressed patients but lack specificity, resulting in false positives.^8,11 More extensive screening instruments, such as the Hospital Anxiety and Depression Scale (HADS), the Brief Symptom Inventory (BSI)-18, and the Psycho-Oncology Screening Tool (POST), have lower rates of false positives but may be more burdensome for providers, especially when considering copyright and cost.⁶

Ambulatory cancer care requires a rapid screening method with high sensitivity and minimal burden.¹² The NCCN Distress Thermometer (DT) has face validity and allows for rapid screening; however, its psychometric properties are not as robust as other instru ments, such as the Center for Epidemiological Studies Depression Scale, the Hospital Anxiety and Depression Scale, Psychological Distress Inventory, or Brief Symptom Inventory.¹³ Although the DT has been shown to identify clinically significant anxiety, it is not as sensitive in identifying depression.⁴

The NCCN DT has 2 parts to the screening: (1) an overall distressintensity score within the past week, including the current day; and (2) an accompanying problem list, grouped into 5 categories, addressing QOL domains.¹⁴ The quantitative score ranges from 0 (no distress) to 10 (extreme distress). The problem list complements the quantitative score by providing information about the source of distress and can help to tailor the intervention (Figure 1). Access to the NCCN Guideline and DT is free for clinical and personal use.

According to the NCCN Guideline, scores of ≥ 4 require distress-management intervention.¹ Mild distress (score < 4) usually can be managed by the primary oncology team.¹⁵ However, if the patient’s score is moderate (4-7) or severe (8-10), urgent intervention is necessary. Depending on the source of the distress, the patient should be seen by the appropriate discipline. For patients with practical problems, such as transportation, finances, and housing issues, a referral to social work is needed. For those with distress related to mental health issues, psychology, psychiatry, or social work may be appropriate.

Patients with distressing physical symptoms should be seen by the physician or advanced practice registered nurse (APRN) from the oncology or palliative care team. With limited psychosocial resources available at many cancer clinics, identification and triage for those with the highest levels of distress are critical.⁵ Triage must incorporate both the total distress score and the components of the distress so that the appropriate disciplines are accessed for the plan of care. More than one discipline may be needed to address multifactorial distress.

Despite strong recommendations from NCCN, ACoS, and many other professional and accrediting agencies, numerous cancer programs face challenges implementing routine screening. This article reports on a large, inner city ambulatory clinic’s pilot project to distress screen all patients at every appointment in the Cancer Center of Excellence (CoE) at Louis Stokes Cleveland VAMC (LSCVAMC) between May 2012 and May 2014 and to provide immediate intervention from the appropriate discipline for patients scoring ≥ 4 on a 0 to 10 DT scale. Results of the screenings, feasibility of screening in an ambulatory VA cancer clinic, and impact on psychosocial resources are presented.

Center of Excellence Project

The LSCVAMC CoE Cancer Care Clinic began as a 3-year grant-funded project from the VA Offices of Specialty Care and Academic Affiliations with 2 major objectives: (1) to deliver quality patient-centered cancer care as measured by implementation of a process for distress screening and management, and development and implementation of a survivorship care plan for patients who have completed cancer treatment; and (2) to provide interprofessional education for the interdisciplinary health care professionals who participate in the clinic as part of their training experience.

Patients in this unique CoE cancer clinic have sameday access to all members of the interdisciplinary and interprofessional team. The ambulatory cancer care CoE team was originally composed of a surgical oncologist, a medical oncologist, a clinical nurse specialist (CNS) patient navigator, a nurse practitioner (NP) in survivorship care, a registered nurse (RN), a psychologist, and an oncology social worker. The project’s patient population included patients with a cancer concern (positive family history and suspicious scans) or a diagnosis of breast cancer, melanoma, sarcoma, or hematologic malignancies. The patient population for the project was based on the CoE team expertise and feasibility of implementation, with plans to roll out the model of care for all patients with any cancer diagnosis across the VAMC at the completion of the project.

The CoE made distress screening and management the leading priority for quality patient-centered care at the start of the project. The purpose of this emphasis on distress screening was to develop a process at LSCVAMC that would meet the 2015 CoC standards and to teach health care professional trainees (NP students, residents, social work students, and fellows in psychology and medical oncology) about distress screening and intervention.

A plan-do-act model of quality improvement (QI) was used to support the development and implementation of the distress-screening process. At the beginning of the project, the institutional review board (IRB) reviewed the protocol and determined that informed consent was not necessary because a QI project for a new standard of care did not require IRB approval. The CoE team met for about 4 months to develop a policy and procedure for the process, based on evidence from national guidelines, a review of the literature, and a discussion of the benefits and burdens of implementation within the current practice.

Limiting initial implementation to a single clinic day made the process more manageable. Descriptive methods analyzed the incidence and percentage of overall distress in this veteran population and quantified the incidences and percentages of each DT component. Feedback from patients and staff offered information on the feasibility of and satisfaction with the process.

From May 2012 to May 2014, all patients who attended the Monday outpatient CoE clinic with a diagnosis of cancer or a cancer concern were given the NCCN, 2.2013 DT instrument by the registration desk clerk at the time they registered for their clinic appointment. ¹⁶ Veterans who had difficulty filling out the DT or who had diminished capacity were assisted in completing the instrument by a designated family member and/or the clinic RN.

The completed instrument was evaluated by the CNS patient navigator, and any patient with a score ≥ 4 received an automatic referral to the behavioral health psychologist, social worker, NP, or all team members and their trainees, depending on the areas of distress (eg, practical, family, and emotional problems, spiritual/religious concerns, and/or physical problems) endorsed by the patient.

A psychiatrist was not embedded into the team but worked closely with the team’s oncology psychologist. The psychologist communicated directly with the psychiatrist, and the plan was shared with the team through the electronic medical record (EMR). The appropriate team member(s) and trainee(s) saw the patient at the visit to address needs in real time. Access to palliative care support and spiritual care was readily available if needed.

Distress screenings were recorded in a templated note in the patient’s EMR, which allowed the team to follow the distress scores on an individual basis across the cancer disease trajectory and to assess response to interventions. Multiple screenings of individuals resulted from the fact that many of the patients were seen monthly or every 3/6/9 months, depending on their disease and treatment status. Because levels of distress can fluctuate, distress was assessed at every visit to determine whether an intervention was needed at that visit. Once distress screenings were recorded in the patient’s EMR, the DT instrument was de-identified and given to the CoE research consultant to enter into a database file for analysis.

Trainees were educated about the use of the DT at time of diagnosis and across the disease trajectory. The 4-week CoE curriculum included 2 weeks of conference time to teach about the roles of psychologist, oncology social worker, and survivorship NP in assessing and initiating interventions to address the multidimensional components of the DT. Trainees working with a veteran who was distressed participated in the assessment(s) and intervention(s) for all components of distress that were endorsed.

Results

A total of 866 distress screenings were performed during the first 2 years of the project. Since all patients were screened at all visits, the 866 distress screenings reflect multiple screenings for 445 unique patients. Of the 866 screenings, 290 (33%) had distress scores of ≥ 4, meeting the criteria for intervention. Screenings reflected patient visits at any point in the disease trajectory. Because this was a new standard of care QI project rather than a research project, additional data, such as diagnosis or staging, were not collected, and IRB approval was not needed.

Because the NCCN Guideline recommendation for intervention is a score of ≥ 4, the descriptive statistics focused on those with moderate-to-severe distress. However, there were numerous occasions when the veteran would report a score of 0 to 3 and still endorse a number of the problems on the DT. The CNS and RN on the team discussed these findings with the appropriate discipline. For example, if the veteran reported a score of 1 but endorsed all 6 components on the emotional problem list, the nurses discussed the patient with the social worker or psychologist to determine whether behavioral health intervention was needed.

The mean distress score for the 290 screenings ≥ 4 was 6.3 on a 0 to 10 scale; median was 6.0 and mode 5.0. Two hundred ten of these screenings (72%) were categorized as moderate distress (4-7), and 80 patients (28%) reported severe distress (Figure 2). If the veteran left a box empty on the problem list, itwas recorded as missing. The frequency that patients reported each type of distress are reported in Figure 3.

The incidence of each component of distress, from those screenings with a score of ≥ 4 is described below, along with case study examples for each component. Team members involved in patient interventions provided these case studies to demonstrate clinical examples of the veteran’s distress from the problem list on the DT.

Practical/Family Distress

Practical issues were reported in 38% of the screenings (109/290). Intervention for moderate-to-severe distress associated with practical problems and family issues was provided by the team social worker. The social worker frequently addressed transportationrelated distress. Providing transportation was essential for adherence to clinic appointments, follow-up testing, treatments, and ultimately, disease management. Housing was also a problem for many veterans. It is critical that patients have access to electricity, heating, food, and water to be able to safely undergo adjuvant therapy. Thus, treatments decisions could be impacted by the veterans’ housing and transportation issues; immediate access to social work support is essential for quality cancer care.

Twenty-six percent of patients that were screened expressed concerns with practical and/or family problems (75/289). Issues of domestic violence, difficulties dealing with a significant other, and concerns about children were referred to social work (Table 1).

Case Study

Ms. S. is a veteran aged 71 years with recently diagnosed breast cancer. She is being seen in the clinic for a postoperative visit following partial mastectomy and is anticipating beginning radiation therapy within the next 3 weeks. She reports a distress score of 7 and identifies concerns about work and transportation to the clinic as the sources of distress. The social worker meets with the patient and learns that she fears losing her job because of the daily travel time to and from radiation and that she cannot afford to travel 65 miles daily to LSCVAMC for radiation. The social worker listens to her concerns and assists her with a plan for short-term disability and VA housing during her radiation therapy treatments. Ms. S. was able to complete radiation at LSCVAMC with temporary housing and to return to work after therapy.

Emotional Distress

Patients who identified that their moderate-to-severe distress was related to emotional problems received same-day intervention from a psychologist skilled in providing emotional support, cognitive behavioral strategies, and assessing the need for referral to either a psychiatrist or oncology social worker. Seventy-one percent of patients reported emotional problems, such as worry, depression, and nervousness (Table 2).

Case Study

Mr. K. is a veteran aged 71 years with a new diagnosis of breast cancer. He lives on his own but has family and a few friends nearby. He reports that he doesn’t like to share his problems with others and has not told anyone of his new diagnosis. Mr. K. rates his distress a 7 and endorses worry, fear, and depression. At a treatment-planning visit, he agrees to see the psychologist for help in dealing with his distress. Treatment involves a mastectomy followed by hormonal therapy.

Mr. K. was scared about having cancer; some of his veteran colleagues have developed cancer recently, and 2 have died. He told the psychologist that he feels worthless and that this disease just makes him more of a burden on society. He has had thoughts of taking his life so that he doesn’t have to deal with cancer, but he does not have a plan. The team formulated a plan to address his anxiety and depression. Mr. K. started a serotonin reuptake inhibitor, and he met with the VA psychiatrist weekly to help develop coping strategies. The team’s psychologist worked closely with Mr. K.’s psychiatrist, and he successfully completed surgery and chemotherapy. He is now being seen in survivorship clinic, continuing care with the team and his psychologist.

Spiritual Distress

Although spiritual/religious concerns are part of DT screening, it is only a single item on the DT. Just 8% of patients (21/276) reported moderate-to-severe spiritual distress. However, there was access to a chaplain at LSCVAMC.

Case Study

Mr. H., a 63-year-old veteran with stage IV melanoma, was seen in the clinic for severe pain in his left hip and ribs (8 on a 10-point scale); he was unresponsive to escalating doses of oxycodone. During the visit, he reported that his distress level is a 10, and in addition to identifying pain as a source of distress, he indicated that he has spiritual distress. When questioned further about spiritual distress, Mr. H. reported that he deserves this pain since he caused so many others pain during his time in Vietnam. The chaplain was contacted, and the patient was seen in clinic at this visit. The chaplain gave him the opportunity to share his feelings of guilt. The importance of spiritual care when the patient is experiencing “total pain” is essential to pain management. Within 3 days, his pain score decreased to an acceptable level of 3 with no additional pharmacologic intervention.

Physical Distress

Physical problems associated with the distress scores were addressed by the surgical and medical oncologists and the APRNs (CNS patient navigator and survivorship NP). When the clinic opened, the team used the Memorial Symptom Assessment Scale to assess physical and psychological symptoms.16 However, patients reported experiencing distress at having to complete 2 tools that had a great deal of overlap. The team determined that the DT could be used as the sole screening tool for all QOL domains.

It is important to note that 92% of patients with moderate-to-severe distress reported physical symptoms as a source of distress (Table 3).

Case Study

Ms. L. is a Vietnam War veteran aged 64 years who was seen in the survivorship clinic. She was diagnosed with estrogen-receptor (ER) and progesterone-receptor (PR) breast cancer 1 year previously, had a lumpectomy followed by radiation therapy, and was on hormonal therapy. She recorded her distress score as a 6 and indicated that multiple physical symptoms were her major concern. She had difficulty with insomnia, fatigue, and hot flashes. The survivorship NP talked with Ms. L. about her symptoms and made nonpharmacologic recommendations for improving sleep, provided an exercise plan for fatigue, and initiated venlafaxine to manage the hot flashes. Ms. L. continued to be seen by the team in survivorship clinic, and during her 3-month follow-up visit, she reported improvement in sleep as the hot flashes diminished.

Multifactoral Distress

Many patients endorsed ≥ 1 component of distress. This required a team approach to intervene for the multifactorial nature of the distress.

Case Study

Mr. K. is a veteran aged 82 years who had been a farmer most of his life. He was cared for at the VA for an advancedstage squamous cell skin cancer of his scalp, which he had allowed to go untreated. The cancer has completely eroded beneath his scalp, and he wore a hat to cover the foul-smelling wound. He lived in rural Ohio with his wife of 55 years; 3 adult daughters lived in the Cleveland area. His daughters served as primary caregivers when Mr. K. came to Cleveland for daily radiation and weekly chemotherapy treatments. He had not been away from his wife since the war and misses her terribly, returning home only on weekends during the 6-week course of radiation.

His primary goal was to return home in time to harvest his farm’s produce 2 months later. He was aware that he has < 6 months to live but wanted chemotherapy and radiation to control the growth of the cancer. During this visit to the ambulatory clinic, he reported a distress score of 5 andidentified family concerns (eg, living away from his wife most of every week) and endorsed emotional concerns of fear, worry, and sadness, and reported pain, fatigue, insomnia, and constipation as physical concerns.

Mr. K. received support from the social worker, the psychologist, and the APRN for symptom management during this visit. The social worker was able to advocate for limited palliative radiation therapy treatments rather than a 6-week course; the psychologist spent 45 minutes talking with him about his fears of a painful death, worries about his wife, and sadness at not being alive for another planting season. The APRN recommended both pharmacologic and nonpharmacologic interventions for his fatigue and insomnia and initiated a pain and bowel pharmacologic regimen. The team respected Mr. K.’s wish to reconsider hospice care at the following visit after he had talked with his wife. Mr. K. died peacefully in his home with his wife and family just before the start of planting season.

Clinical Implications

Distress screening and intervention is essential for quality cancer care. While a great deal of controversy exists about the best time to screen for distress, the LSCVAMC CoE has taken on the challenge of screening and intervening in real time at every patient visit across the disease trajectory. The model of distress screening all veterans at CoE clinic visits has been rolled out to other cancer clinics at LSCVAMC.

Distress screening at each visit is not time intensive. Patients are willing to fill out the instrument while waiting for their clinic visit, and most patients find that it takes less than 5 minutes to complete. The major challenge for institutions considering screening with each visit is not the screening but access to appropriate providers able to provide timely intervention. The success of this model results, in part, because the clinic RN assesses the responses to the DT and refers to the appropriate discipline, utilizing precious resources of social work and psychology appropriately. The VA system is already committed to improving the psychosocial well-being of veterans and has established social work and psychology resources specifically for the cancer clinics.

Many patients reported to the authors that they might not have been able or willing to return to LSCVAMC to see the behavioral health specialists on another day. In addition, scheduling behavioral health appointments at another time would not allow for attending to the distress in real time. Also, from a systems standpoint, it would have been an added cost to the VA and/or the veteran for transportation for additional appointments on different days.

Finally, although the impact of the CoE project on health professional trainees has been reported elsewhere, the distress screening and intervention process were valued as being very positive for all trainees who participated in CoE clinic.¹⁷ The trainees were able to stay with the patient for the entire clinic visit, including the visits made by disciplines other than their own. For example, the family medicine residents stayed with the patient they examined to observe the distress assessments and interventions offered by the social worker and/or psychologist for the patients who scored ≥ 4 on the DT.

At the end of their rotations in the CoE, trainees reported an increased awareness of the importance of distress screening in a cancer clinic. Many were not aware of the NCCN guidelines and the ACoS CoC mandate for distress screening as a standard of cancer care. Interdisciplinary trainees rated the CoE curriculum and the conference teaching/learning sessions on distress management highly. However, observing the role of the social worker and psychologist were the most valuable to trainees, regardless of the area of practice they enter.

Conclusion

Addressing practical, psychosocial, physical, and spiritual needs will help decrease distress, support patients’ ability to tolerate treatment, and improve veterans’ QOL across the cancer-disease trajectory. Screening all patients at an outpatient cancer clinic at LSCVAMC is feasible and does not seem to be a burden for patients or providers. This pilot project has become standard of care across the LSCVAMC cancer clinics, demonstrating its sustainability.

Screening with the DT provides information about the intensity of the distress and the components contributing to the distress. The most important aspect of the screening is assessing the components of the distress and providing real-time intervention from the appropriate discipline. It is critical that the oncology team refer to the appropriate discipline based on the source of the distress rather than on only the intensity. Findings from this project indicate that physical symptoms are frequently the source of distress and may not require behavioral health intervention. However, for patients with psychosocial needs, rapid access to behavioral health care services is critical for quality veteran-centered cancer care.

Since 2015, all VA cancer centers are required to have implemented distress screening. According to the CoC, at least 1 screening must be done on every patient.¹⁰ Many institutions have begun to screen at diagnosis, but it is well known that there are many points along the cancer trajectory when patients may experience an increase in distress. Simple screening with the DT at every cancer clinic visit helps identify the veterans’ needs at any point along the disease spectrum.

At LSCVAMC, the CoE was designed as an interdisciplinary cancer clinic. With the conclusion of funding in FY 2015, the clinic has continued to function. The rollout into other clinics has continued with movement toward use of formal consult requests and continual, real-time evaluation of the process. Work on accurate, timely identification of new cancer patients and identifying pivotal cancer visits is underway. The LSCVAMC is committed to improving care and access to its veterans with cancer to ensure appropriate and adequate services across the cancer trajectory.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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A diagnosis of cancer, its treatment, and surveillance are fraught with distress. Distress is defined by the National Comprehensive Cancer Network^® (NCCN^®) as “a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms, and its treatment.”¹ Distress is known to occur at any point along the cancer-disease trajectory: during diagnosis, during treatment, at the end of treatment, at pivotal treatment decision points, from survivorship through to end of life.² The severity of the distress can range from “common normal feelings of vulnerability, sadness, and fears to problems that can become disabling, such as depression, anxiety, panic, social isolation, and existential and spiritual crisis.”¹ Most important, the impact of distress has been associated with reduced quality of life (QOL) and potentially reduced survival.^3,4

About 33% of all persons with cancer experience severe distress.^5,6 As a result of the prevalence and severity of distress, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management recommend that all patients with cancer should be screened for distress, using a standardized tool, at their initial visit, at appropriate intervals, and as clinically indicated.¹ The time line for longitudinal screening of “appropriate intervals” has not been firmly established.² However, it is well recognized that appropriate intervals include times of vulnerability such as remission, recurrence, termination of treatment, and progression.^1,7 Despite efforts to improve distress screening and intervention, many institutions struggle to adhere to the NCCN Guidelines®.^8,9

In 2012, the American College of Surgeons Commission on Cancer (ACoS CoC) identified distress screening as an essential accreditation standard by 2015.¹⁰ The standard mandates that patients be screened a minimum of 1 time at a “pivotal” medical visit (such as time of diagnosis, transitions in cancer treatment, recurrence, completion of cancer treatment, and progression of disease). In practice, most institutions typically screen at diagnosis.² According to the ACoS CoC, 41 VAMCs are accredited sites that will be impacted by the implementation of this standard.¹⁰

Distress Screening Tools

A major challenge and barrier to integrating distress screening in cancer clinics is the lack of consensus on the best measurement tool in a busy ambulatory clinic. Although a number of screening tools are available for measuring cancer-related distress, they vary in efficacy and feasibility. According to Zabora and Macmurray, the perfect screening instrument for distress in persons with cancer does not exist.6 Brief screening tools demonstrate high sensitivity in identifying very distressed patients but lack specificity, resulting in false positives.^8,11 More extensive screening instruments, such as the Hospital Anxiety and Depression Scale (HADS), the Brief Symptom Inventory (BSI)-18, and the Psycho-Oncology Screening Tool (POST), have lower rates of false positives but may be more burdensome for providers, especially when considering copyright and cost.⁶

Ambulatory cancer care requires a rapid screening method with high sensitivity and minimal burden.¹² The NCCN Distress Thermometer (DT) has face validity and allows for rapid screening; however, its psychometric properties are not as robust as other instru ments, such as the Center for Epidemiological Studies Depression Scale, the Hospital Anxiety and Depression Scale, Psychological Distress Inventory, or Brief Symptom Inventory.¹³ Although the DT has been shown to identify clinically significant anxiety, it is not as sensitive in identifying depression.⁴

The NCCN DT has 2 parts to the screening: (1) an overall distressintensity score within the past week, including the current day; and (2) an accompanying problem list, grouped into 5 categories, addressing QOL domains.¹⁴ The quantitative score ranges from 0 (no distress) to 10 (extreme distress). The problem list complements the quantitative score by providing information about the source of distress and can help to tailor the intervention (Figure 1). Access to the NCCN Guideline and DT is free for clinical and personal use.

According to the NCCN Guideline, scores of ≥ 4 require distress-management intervention.¹ Mild distress (score < 4) usually can be managed by the primary oncology team.¹⁵ However, if the patient’s score is moderate (4-7) or severe (8-10), urgent intervention is necessary. Depending on the source of the distress, the patient should be seen by the appropriate discipline. For patients with practical problems, such as transportation, finances, and housing issues, a referral to social work is needed. For those with distress related to mental health issues, psychology, psychiatry, or social work may be appropriate.

Patients with distressing physical symptoms should be seen by the physician or advanced practice registered nurse (APRN) from the oncology or palliative care team. With limited psychosocial resources available at many cancer clinics, identification and triage for those with the highest levels of distress are critical.⁵ Triage must incorporate both the total distress score and the components of the distress so that the appropriate disciplines are accessed for the plan of care. More than one discipline may be needed to address multifactorial distress.

Despite strong recommendations from NCCN, ACoS, and many other professional and accrediting agencies, numerous cancer programs face challenges implementing routine screening. This article reports on a large, inner city ambulatory clinic’s pilot project to distress screen all patients at every appointment in the Cancer Center of Excellence (CoE) at Louis Stokes Cleveland VAMC (LSCVAMC) between May 2012 and May 2014 and to provide immediate intervention from the appropriate discipline for patients scoring ≥ 4 on a 0 to 10 DT scale. Results of the screenings, feasibility of screening in an ambulatory VA cancer clinic, and impact on psychosocial resources are presented.

Center of Excellence Project

The LSCVAMC CoE Cancer Care Clinic began as a 3-year grant-funded project from the VA Offices of Specialty Care and Academic Affiliations with 2 major objectives: (1) to deliver quality patient-centered cancer care as measured by implementation of a process for distress screening and management, and development and implementation of a survivorship care plan for patients who have completed cancer treatment; and (2) to provide interprofessional education for the interdisciplinary health care professionals who participate in the clinic as part of their training experience.

Patients in this unique CoE cancer clinic have sameday access to all members of the interdisciplinary and interprofessional team. The ambulatory cancer care CoE team was originally composed of a surgical oncologist, a medical oncologist, a clinical nurse specialist (CNS) patient navigator, a nurse practitioner (NP) in survivorship care, a registered nurse (RN), a psychologist, and an oncology social worker. The project’s patient population included patients with a cancer concern (positive family history and suspicious scans) or a diagnosis of breast cancer, melanoma, sarcoma, or hematologic malignancies. The patient population for the project was based on the CoE team expertise and feasibility of implementation, with plans to roll out the model of care for all patients with any cancer diagnosis across the VAMC at the completion of the project.

The CoE made distress screening and management the leading priority for quality patient-centered care at the start of the project. The purpose of this emphasis on distress screening was to develop a process at LSCVAMC that would meet the 2015 CoC standards and to teach health care professional trainees (NP students, residents, social work students, and fellows in psychology and medical oncology) about distress screening and intervention.

A plan-do-act model of quality improvement (QI) was used to support the development and implementation of the distress-screening process. At the beginning of the project, the institutional review board (IRB) reviewed the protocol and determined that informed consent was not necessary because a QI project for a new standard of care did not require IRB approval. The CoE team met for about 4 months to develop a policy and procedure for the process, based on evidence from national guidelines, a review of the literature, and a discussion of the benefits and burdens of implementation within the current practice.

Limiting initial implementation to a single clinic day made the process more manageable. Descriptive methods analyzed the incidence and percentage of overall distress in this veteran population and quantified the incidences and percentages of each DT component. Feedback from patients and staff offered information on the feasibility of and satisfaction with the process.

From May 2012 to May 2014, all patients who attended the Monday outpatient CoE clinic with a diagnosis of cancer or a cancer concern were given the NCCN, 2.2013 DT instrument by the registration desk clerk at the time they registered for their clinic appointment. ¹⁶ Veterans who had difficulty filling out the DT or who had diminished capacity were assisted in completing the instrument by a designated family member and/or the clinic RN.

The completed instrument was evaluated by the CNS patient navigator, and any patient with a score ≥ 4 received an automatic referral to the behavioral health psychologist, social worker, NP, or all team members and their trainees, depending on the areas of distress (eg, practical, family, and emotional problems, spiritual/religious concerns, and/or physical problems) endorsed by the patient.

A psychiatrist was not embedded into the team but worked closely with the team’s oncology psychologist. The psychologist communicated directly with the psychiatrist, and the plan was shared with the team through the electronic medical record (EMR). The appropriate team member(s) and trainee(s) saw the patient at the visit to address needs in real time. Access to palliative care support and spiritual care was readily available if needed.

Distress screenings were recorded in a templated note in the patient’s EMR, which allowed the team to follow the distress scores on an individual basis across the cancer disease trajectory and to assess response to interventions. Multiple screenings of individuals resulted from the fact that many of the patients were seen monthly or every 3/6/9 months, depending on their disease and treatment status. Because levels of distress can fluctuate, distress was assessed at every visit to determine whether an intervention was needed at that visit. Once distress screenings were recorded in the patient’s EMR, the DT instrument was de-identified and given to the CoE research consultant to enter into a database file for analysis.

Trainees were educated about the use of the DT at time of diagnosis and across the disease trajectory. The 4-week CoE curriculum included 2 weeks of conference time to teach about the roles of psychologist, oncology social worker, and survivorship NP in assessing and initiating interventions to address the multidimensional components of the DT. Trainees working with a veteran who was distressed participated in the assessment(s) and intervention(s) for all components of distress that were endorsed.

Results

A total of 866 distress screenings were performed during the first 2 years of the project. Since all patients were screened at all visits, the 866 distress screenings reflect multiple screenings for 445 unique patients. Of the 866 screenings, 290 (33%) had distress scores of ≥ 4, meeting the criteria for intervention. Screenings reflected patient visits at any point in the disease trajectory. Because this was a new standard of care QI project rather than a research project, additional data, such as diagnosis or staging, were not collected, and IRB approval was not needed.

Because the NCCN Guideline recommendation for intervention is a score of ≥ 4, the descriptive statistics focused on those with moderate-to-severe distress. However, there were numerous occasions when the veteran would report a score of 0 to 3 and still endorse a number of the problems on the DT. The CNS and RN on the team discussed these findings with the appropriate discipline. For example, if the veteran reported a score of 1 but endorsed all 6 components on the emotional problem list, the nurses discussed the patient with the social worker or psychologist to determine whether behavioral health intervention was needed.

The mean distress score for the 290 screenings ≥ 4 was 6.3 on a 0 to 10 scale; median was 6.0 and mode 5.0. Two hundred ten of these screenings (72%) were categorized as moderate distress (4-7), and 80 patients (28%) reported severe distress (Figure 2). If the veteran left a box empty on the problem list, itwas recorded as missing. The frequency that patients reported each type of distress are reported in Figure 3.

The incidence of each component of distress, from those screenings with a score of ≥ 4 is described below, along with case study examples for each component. Team members involved in patient interventions provided these case studies to demonstrate clinical examples of the veteran’s distress from the problem list on the DT.

Practical/Family Distress

Practical issues were reported in 38% of the screenings (109/290). Intervention for moderate-to-severe distress associated with practical problems and family issues was provided by the team social worker. The social worker frequently addressed transportationrelated distress. Providing transportation was essential for adherence to clinic appointments, follow-up testing, treatments, and ultimately, disease management. Housing was also a problem for many veterans. It is critical that patients have access to electricity, heating, food, and water to be able to safely undergo adjuvant therapy. Thus, treatments decisions could be impacted by the veterans’ housing and transportation issues; immediate access to social work support is essential for quality cancer care.

Twenty-six percent of patients that were screened expressed concerns with practical and/or family problems (75/289). Issues of domestic violence, difficulties dealing with a significant other, and concerns about children were referred to social work (Table 1).

Case Study

Ms. S. is a veteran aged 71 years with recently diagnosed breast cancer. She is being seen in the clinic for a postoperative visit following partial mastectomy and is anticipating beginning radiation therapy within the next 3 weeks. She reports a distress score of 7 and identifies concerns about work and transportation to the clinic as the sources of distress. The social worker meets with the patient and learns that she fears losing her job because of the daily travel time to and from radiation and that she cannot afford to travel 65 miles daily to LSCVAMC for radiation. The social worker listens to her concerns and assists her with a plan for short-term disability and VA housing during her radiation therapy treatments. Ms. S. was able to complete radiation at LSCVAMC with temporary housing and to return to work after therapy.

Emotional Distress

Patients who identified that their moderate-to-severe distress was related to emotional problems received same-day intervention from a psychologist skilled in providing emotional support, cognitive behavioral strategies, and assessing the need for referral to either a psychiatrist or oncology social worker. Seventy-one percent of patients reported emotional problems, such as worry, depression, and nervousness (Table 2).

Case Study

Mr. K. is a veteran aged 71 years with a new diagnosis of breast cancer. He lives on his own but has family and a few friends nearby. He reports that he doesn’t like to share his problems with others and has not told anyone of his new diagnosis. Mr. K. rates his distress a 7 and endorses worry, fear, and depression. At a treatment-planning visit, he agrees to see the psychologist for help in dealing with his distress. Treatment involves a mastectomy followed by hormonal therapy.

Mr. K. was scared about having cancer; some of his veteran colleagues have developed cancer recently, and 2 have died. He told the psychologist that he feels worthless and that this disease just makes him more of a burden on society. He has had thoughts of taking his life so that he doesn’t have to deal with cancer, but he does not have a plan. The team formulated a plan to address his anxiety and depression. Mr. K. started a serotonin reuptake inhibitor, and he met with the VA psychiatrist weekly to help develop coping strategies. The team’s psychologist worked closely with Mr. K.’s psychiatrist, and he successfully completed surgery and chemotherapy. He is now being seen in survivorship clinic, continuing care with the team and his psychologist.

Spiritual Distress

Although spiritual/religious concerns are part of DT screening, it is only a single item on the DT. Just 8% of patients (21/276) reported moderate-to-severe spiritual distress. However, there was access to a chaplain at LSCVAMC.

Case Study

Mr. H., a 63-year-old veteran with stage IV melanoma, was seen in the clinic for severe pain in his left hip and ribs (8 on a 10-point scale); he was unresponsive to escalating doses of oxycodone. During the visit, he reported that his distress level is a 10, and in addition to identifying pain as a source of distress, he indicated that he has spiritual distress. When questioned further about spiritual distress, Mr. H. reported that he deserves this pain since he caused so many others pain during his time in Vietnam. The chaplain was contacted, and the patient was seen in clinic at this visit. The chaplain gave him the opportunity to share his feelings of guilt. The importance of spiritual care when the patient is experiencing “total pain” is essential to pain management. Within 3 days, his pain score decreased to an acceptable level of 3 with no additional pharmacologic intervention.

Physical Distress

Physical problems associated with the distress scores were addressed by the surgical and medical oncologists and the APRNs (CNS patient navigator and survivorship NP). When the clinic opened, the team used the Memorial Symptom Assessment Scale to assess physical and psychological symptoms.16 However, patients reported experiencing distress at having to complete 2 tools that had a great deal of overlap. The team determined that the DT could be used as the sole screening tool for all QOL domains.

It is important to note that 92% of patients with moderate-to-severe distress reported physical symptoms as a source of distress (Table 3).

Case Study

Ms. L. is a Vietnam War veteran aged 64 years who was seen in the survivorship clinic. She was diagnosed with estrogen-receptor (ER) and progesterone-receptor (PR) breast cancer 1 year previously, had a lumpectomy followed by radiation therapy, and was on hormonal therapy. She recorded her distress score as a 6 and indicated that multiple physical symptoms were her major concern. She had difficulty with insomnia, fatigue, and hot flashes. The survivorship NP talked with Ms. L. about her symptoms and made nonpharmacologic recommendations for improving sleep, provided an exercise plan for fatigue, and initiated venlafaxine to manage the hot flashes. Ms. L. continued to be seen by the team in survivorship clinic, and during her 3-month follow-up visit, she reported improvement in sleep as the hot flashes diminished.

Multifactoral Distress

Many patients endorsed ≥ 1 component of distress. This required a team approach to intervene for the multifactorial nature of the distress.

Case Study

Mr. K. is a veteran aged 82 years who had been a farmer most of his life. He was cared for at the VA for an advancedstage squamous cell skin cancer of his scalp, which he had allowed to go untreated. The cancer has completely eroded beneath his scalp, and he wore a hat to cover the foul-smelling wound. He lived in rural Ohio with his wife of 55 years; 3 adult daughters lived in the Cleveland area. His daughters served as primary caregivers when Mr. K. came to Cleveland for daily radiation and weekly chemotherapy treatments. He had not been away from his wife since the war and misses her terribly, returning home only on weekends during the 6-week course of radiation.

His primary goal was to return home in time to harvest his farm’s produce 2 months later. He was aware that he has < 6 months to live but wanted chemotherapy and radiation to control the growth of the cancer. During this visit to the ambulatory clinic, he reported a distress score of 5 andidentified family concerns (eg, living away from his wife most of every week) and endorsed emotional concerns of fear, worry, and sadness, and reported pain, fatigue, insomnia, and constipation as physical concerns.

Mr. K. received support from the social worker, the psychologist, and the APRN for symptom management during this visit. The social worker was able to advocate for limited palliative radiation therapy treatments rather than a 6-week course; the psychologist spent 45 minutes talking with him about his fears of a painful death, worries about his wife, and sadness at not being alive for another planting season. The APRN recommended both pharmacologic and nonpharmacologic interventions for his fatigue and insomnia and initiated a pain and bowel pharmacologic regimen. The team respected Mr. K.’s wish to reconsider hospice care at the following visit after he had talked with his wife. Mr. K. died peacefully in his home with his wife and family just before the start of planting season.

Clinical Implications

Distress screening and intervention is essential for quality cancer care. While a great deal of controversy exists about the best time to screen for distress, the LSCVAMC CoE has taken on the challenge of screening and intervening in real time at every patient visit across the disease trajectory. The model of distress screening all veterans at CoE clinic visits has been rolled out to other cancer clinics at LSCVAMC.

Distress screening at each visit is not time intensive. Patients are willing to fill out the instrument while waiting for their clinic visit, and most patients find that it takes less than 5 minutes to complete. The major challenge for institutions considering screening with each visit is not the screening but access to appropriate providers able to provide timely intervention. The success of this model results, in part, because the clinic RN assesses the responses to the DT and refers to the appropriate discipline, utilizing precious resources of social work and psychology appropriately. The VA system is already committed to improving the psychosocial well-being of veterans and has established social work and psychology resources specifically for the cancer clinics.

Many patients reported to the authors that they might not have been able or willing to return to LSCVAMC to see the behavioral health specialists on another day. In addition, scheduling behavioral health appointments at another time would not allow for attending to the distress in real time. Also, from a systems standpoint, it would have been an added cost to the VA and/or the veteran for transportation for additional appointments on different days.

Finally, although the impact of the CoE project on health professional trainees has been reported elsewhere, the distress screening and intervention process were valued as being very positive for all trainees who participated in CoE clinic.¹⁷ The trainees were able to stay with the patient for the entire clinic visit, including the visits made by disciplines other than their own. For example, the family medicine residents stayed with the patient they examined to observe the distress assessments and interventions offered by the social worker and/or psychologist for the patients who scored ≥ 4 on the DT.

At the end of their rotations in the CoE, trainees reported an increased awareness of the importance of distress screening in a cancer clinic. Many were not aware of the NCCN guidelines and the ACoS CoC mandate for distress screening as a standard of cancer care. Interdisciplinary trainees rated the CoE curriculum and the conference teaching/learning sessions on distress management highly. However, observing the role of the social worker and psychologist were the most valuable to trainees, regardless of the area of practice they enter.

Conclusion

Addressing practical, psychosocial, physical, and spiritual needs will help decrease distress, support patients’ ability to tolerate treatment, and improve veterans’ QOL across the cancer-disease trajectory. Screening all patients at an outpatient cancer clinic at LSCVAMC is feasible and does not seem to be a burden for patients or providers. This pilot project has become standard of care across the LSCVAMC cancer clinics, demonstrating its sustainability.

Screening with the DT provides information about the intensity of the distress and the components contributing to the distress. The most important aspect of the screening is assessing the components of the distress and providing real-time intervention from the appropriate discipline. It is critical that the oncology team refer to the appropriate discipline based on the source of the distress rather than on only the intensity. Findings from this project indicate that physical symptoms are frequently the source of distress and may not require behavioral health intervention. However, for patients with psychosocial needs, rapid access to behavioral health care services is critical for quality veteran-centered cancer care.

Since 2015, all VA cancer centers are required to have implemented distress screening. According to the CoC, at least 1 screening must be done on every patient.¹⁰ Many institutions have begun to screen at diagnosis, but it is well known that there are many points along the cancer trajectory when patients may experience an increase in distress. Simple screening with the DT at every cancer clinic visit helps identify the veterans’ needs at any point along the disease spectrum.

At LSCVAMC, the CoE was designed as an interdisciplinary cancer clinic. With the conclusion of funding in FY 2015, the clinic has continued to function. The rollout into other clinics has continued with movement toward use of formal consult requests and continual, real-time evaluation of the process. Work on accurate, timely identification of new cancer patients and identifying pivotal cancer visits is underway. The LSCVAMC is committed to improving care and access to its veterans with cancer to ensure appropriate and adequate services across the cancer trajectory.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here to read the digital edition.

As early as 500 bc , fasting was used as an effective treatment for many medical ailments. Fasting continued into modern times, and in 1910, Guelpa and Marie proposed fasting as an antiepilepsy treatment. In 1921, Woodyatt noted that starvation or use of high-fat, low-carbohydrate diets in individuals with no significant medical comorbidities yielded acetone and β-hydroxybutyrate, 2 energy sources produced by the liver in the absence of glucose. A low-carbohydrate, high-fat diet was thought to be an alternative to fasting or starvation, having many of the same desired effects while continuing to nourish healthy cells. The term ketogenic diet (KD) was later coined by Wilder and Peterman, who formulated the fat-to-carbohydrate ratio that is still used today: 1 g protein per kg of body weight in children and 10 to 15 g carbohydrates daily, and fat for the remainder of calories. Both investigators reported that this diet improved their patients’ mentation and cognition.¹

Use of the KD as an adjuvant to cancer therapy also began to emerge. In 1922, Braunstein noted that glucose disappeared from the urine of patients with diabetes after they were diagnosed with cancer, suggesting that glucose is recruited to cancerous areas where it is consumed at higher than normal rates. During that same time, Nobel laureate Otto Warburg found that cancer cells thrive on glycolysis, producing high lactate levels, even in the presence of abundant oxygen. Warburg conducted many in vitro and animal experiments demonstrating this outcome, known as the Warburg effect.

By the mid-20th century, KD use in epilepsy treatment and cancer research had waned. However, in the mid-to-late 1990s, with the establishment of the Charlie Foundation, the diet slowly started regaining recognition.¹ Results of many in vitro and animal studies were reported, and human data also began to accumulate.

Mechanism of Action

Glucose normally stimulates pancreatic β cells to release insulin, which allows glucose to enter cells and provide energy. With high carbohydrate and glucose intake, the pancreas increasingly secretes more insulin, which promotes the interaction of growth hormone receptors and growth hormones to produce insulin-like growth factor 1 (IGF-1) in the liver—promoting cell growth and proliferation, which can be detrimental to patients with cancer. Overexpression of glucose transporters 1 and 3 (Glut-1, Glut-3) also occurs in many cancers and corresponds to the degree of glucose uptake in aggressive tumors, as seen on positron emission tomography (PET).² Overexpression of hexokinase, the rate-limiting enzyme of glycolysis, further drives production of pyruvate and lactate, which cause reactive oxygen species damage. Translocation of the hexokinase rate-limiting enzyme from the cytosol into the outer mitochondrial membrane, where it interacts with voltage-dependent anion channels, can disrupt caspasedependent cytochrome release, which suppresses the apoptotic pathways of cancer cells and makes cancer more resistant to chemotherapy.³

When glucose is scarce, the body senses the need to make an alternative form of energy for cells. The liver then produces ketones and fatty acids, which provide for normal cells but do not benefit cancer cells. Cancer cells have dysfunctional mitochondria and possibly electron transport chain defects, which disrupt normal adenosine triphosphate (ATP) production from the mitochondria. The result is that the cancer cells become heavily dependent on ATP coming from the less efficient process of glycolysis (Figure 1).

Ketogenic diets mimic the fasting state, wherein the body responds to the lack of glucose by producing ketones for energy. Excess lactate production, which is part of the Warburg effect, compensates for ATP production defects caused by dysfunctional mitochondrial oxidative phosphorylation.^2,4 The resulting tumor dependence on glucose can be exploited with KD use. Ketogenic diets selectively starve tumors by providing the fat and protein that otherwise could not be used by glucose-dependent tumor cells.

In KDs, the 4:1 ratio of high fat to low carbohydrates mimics the metabolic effects of starvation (Figure 2). These diets slow cancer by inhibiting insulin/IGF and downstream intracellular signaling pathways, such as

Ketogenic Diet Benefits

There are concerns about providing protein to patients who are at risk for renal problems. However, mouse models of diabetic nephropathy showed improved renal function with KD use. The hypothesis was that KD use, which produces prolonged elevated 3-β-hydroxybutyric acid levels, also reduces molecular responses to glucose and consequently reduces renal damage.⁶ Use of the diet also reduced pain and inflammation in both juvenile and adult rats. Mechanisms of action were thought to be reduced reactive oxygen species and increased central adenosine levels.^7,8

Adverse Effects

Dieting is of concern to cancer patients worried about additional weight loss. The standard diet is made up predominantly of carbohydrates and is high in caloric value (Figure 3). Beck and Tisdale investigated the effect of KD use on delaying cachexia in mouse models of colon carcinoma. They found that dieting was more effective than insulin in reversing weight loss and had the added effect of reducing tumor size.⁷ Moreover, Tisdale and colleagues found that KD use in cachectic cancer patients could promote weight gain.⁸

A possible explanation is that healthy tissue nutrition selectively delays tumor growth, while cancer cells are deprived of nutrition (carbohydrates). A therapeutic weight plateau should follow initial weight loss with KD, in contrast to pathologic rapid weight loss in non-KD patients.⁹ Kidney stones, gout, and symptomatic hypoglycemia were also potential expected adverse effects (AEs).

Case Reports

In 1962, the New York Department of Mental Hygiene published an article about 2 women whose metastatic cancers disappeared after a series of daily hypoglycemiainduced insulin comas (brief and reversible). These patients could not undergo conventional electric shock therapy, hence, the medically induced psychotherapy. Not only did their psychotic and depressive symptoms resolve, but their cancers (grossly visible cervical cancer and metastatic melanoma) became undetectable as early as 2 months into treatment.¹⁰ Zuccoli and colleagues reported on a glioblastoma that was effectively treated with temozolomide oral chemotherapy after the patient was weaned off steroids. The patient had a radiographic response and good tumor control for about a year, before discontinuing the diet. She transitioned to chemotherapy, which included bevacizumab (antivascular endothelial growth factor), but the disease progressed and she died.¹¹ In addition, during 8 weeks of ketogenic dieting, 2 pediatric female astrocytoma patients experienced improved mood and showed decreased glucose uptake on PET-computed tomography (PET-CT) of their tumor sites. One of these patients continued the diet and remained disease-free another 12 months.¹² These early case reports provide compelling evidence for further research into the role of glucose metabolism in cancer
treatment.

Current Research

Compared with normal mice, tumor-bearing mice placed on a low-carbohydrate diet had lower glucose, insulin, and lactic acid levels.⁴ An in vivo microdialysis study of patients with head and neck cancers found decreased lactic acid levels in the tumor tissues after a 4-day KD.¹³ Most early studies and case reports involving KD in cancer focused on brain tumors.^11,14-16 Human clinical studies on this diet in cancer care were limited to small, nonrandomized, brief trials (4-12 weeks) or single case studies (Table).^11,17-20

Fine and colleagues conducted a 4-week feasibility study of the low-carbohydrate modified Atkins KD (≤ 20 g of carbohydrates daily) in PET-positive advanced cancer patients with solid tumors. There was a correlation between insulin levels and ketosis but not IGF. Stable disease or partial remission (measured standardized uptake value) on PET-CT correlated with 3-fold higher ketosis (but not weight loss or reduced caloric intake) relative to patients with progressive disease.¹⁷ In the ERGO trial, Rieger and colleagues studied 20 relapsed glioblastoma patients who were on KD supplemented with plant oils.¹⁸ Calories were unlimited. The primary endpoint was percentage of patients who discontinued the diet. Mean weight loss was significant, but quality of life (QOL) was maintained. The investigators also studied the effects of KD alone or combined with bevacizumab in a mouse glioblastoma model. In this mouse study, KD alone had no effect; however, it increased median survival from 52 to 58 days (P < .05) with bevacizumab.

In a pilot study, Schmidt and colleagues provided KD plus oil-protein shakes as snacks to 7 of 16 patients with a variety of advanced metastatic cancers. Mean weight loss was statistically significant, blood lipid or cholesterol levels remained stable, some QOL measures improved, and there were no severe AEs.¹⁹ Schwartz and colleagues reviewed the cases of 32 glioma patients treated with energy restricted KDs —5 from case reports, 19 from a clinical trial by Rieger and colleagues, and 8 from Champ.^18,20,21 They also reported on 2 of their own glioma cases treated with the energy-restricted KD and studied tissues for expression of key ketolytic enzymes. Prolonged remission was noted from 4 months to more than 5 years in these case reports.²⁰

The VA Pittsburgh Healthcare System safety that trial enrolled 17 patients, 11 of whom were evaluated. Mean weight loss was significant, and weight loss of ≥ 10% was noted in responders (stable or improved disease) compared with nonresponders. Three patients dieted longer than 16 weeks (survival, 80-116 weeks). One of these patients was alive at 121 weeks.²²

The safety and feasibility data suggest that cancer patients can tolerate KD use. Investigators should consider combining the KD approach with standard treatment modalities, including chemotherapy and radiation.

Already investigators have conducted in vitro studies of the effect of gene expression of ketolytic and glycolytic enzymes within tumor tissue on KD response. Tumors expressing mutations in key mitochondrial oxidative phosphorylation enzymes were more likely to respond to KD use than were tumors without mutations.^16,23

Ongoing Clinical Trials

Duke University has initiated a randomized study (NCT00932672) of the Atkins diet and androgen deprivation therapy for patients with prostate cancer. Tel Aviv Sourasky Medical Center in Israel is recruiting previously treated chemoradiation patients with high-grade glial tumors for an open-label study (NCT01092247) of the efficacy of KD in preventing tumor growth and recurrence. St. Joseph’s Hospital and Medical Center (Phoenix, AZ) is recruiting newly diagnosed glioblastoma patients for a phase 1/2 prospective trial (NCT02046187) involving upfront resection followed by KD with radiotherapy and concurrent temozolomide, followed by adjuvant temozolomide chemotherapy. The primary endpoint is number of patients with AEs and the secondary endpoints are overall survival, time to progression, and QOL. The University of Iowa is recruiting patients with prostate cancer and non-small cell lung cancer for 2 phase 1 studies (NCT01419483 and NCT01419587, respectively) involving KD using Nutritia KetoCal 4:1 (Gaithersburg, MD).

Conclusion

Data from case reports and trials suggest KD use is safe and tolerable for patients with cancer. Although it would be ideal to conduct a larger trial using a randomized therapeutic approach, the current emphasis on drug-based trials is a formidable obstacle. Other major obstacles are patient initiative and adherence. For now, investigators must work with anecdotal data. Examination of gene expression patterns in mitochondria and mutations in ketolytic and glycolytic enzymes may prove useful in selecting potentially responsive patients. Combining this dietary approach with standard chemotherapeutic and radiotherapeutic options may help improve tumor response, and further research is desperately needed.

Click to read the digital edition.

As early as 500 bc , fasting was used as an effective treatment for many medical ailments. Fasting continued into modern times, and in 1910, Guelpa and Marie proposed fasting as an antiepilepsy treatment. In 1921, Woodyatt noted that starvation or use of high-fat, low-carbohydrate diets in individuals with no significant medical comorbidities yielded acetone and β-hydroxybutyrate, 2 energy sources produced by the liver in the absence of glucose. A low-carbohydrate, high-fat diet was thought to be an alternative to fasting or starvation, having many of the same desired effects while continuing to nourish healthy cells. The term ketogenic diet (KD) was later coined by Wilder and Peterman, who formulated the fat-to-carbohydrate ratio that is still used today: 1 g protein per kg of body weight in children and 10 to 15 g carbohydrates daily, and fat for the remainder of calories. Both investigators reported that this diet improved their patients’ mentation and cognition.¹

Use of the KD as an adjuvant to cancer therapy also began to emerge. In 1922, Braunstein noted that glucose disappeared from the urine of patients with diabetes after they were diagnosed with cancer, suggesting that glucose is recruited to cancerous areas where it is consumed at higher than normal rates. During that same time, Nobel laureate Otto Warburg found that cancer cells thrive on glycolysis, producing high lactate levels, even in the presence of abundant oxygen. Warburg conducted many in vitro and animal experiments demonstrating this outcome, known as the Warburg effect.

By the mid-20th century, KD use in epilepsy treatment and cancer research had waned. However, in the mid-to-late 1990s, with the establishment of the Charlie Foundation, the diet slowly started regaining recognition.¹ Results of many in vitro and animal studies were reported, and human data also began to accumulate.

Mechanism of Action

Glucose normally stimulates pancreatic β cells to release insulin, which allows glucose to enter cells and provide energy. With high carbohydrate and glucose intake, the pancreas increasingly secretes more insulin, which promotes the interaction of growth hormone receptors and growth hormones to produce insulin-like growth factor 1 (IGF-1) in the liver—promoting cell growth and proliferation, which can be detrimental to patients with cancer. Overexpression of glucose transporters 1 and 3 (Glut-1, Glut-3) also occurs in many cancers and corresponds to the degree of glucose uptake in aggressive tumors, as seen on positron emission tomography (PET).² Overexpression of hexokinase, the rate-limiting enzyme of glycolysis, further drives production of pyruvate and lactate, which cause reactive oxygen species damage. Translocation of the hexokinase rate-limiting enzyme from the cytosol into the outer mitochondrial membrane, where it interacts with voltage-dependent anion channels, can disrupt caspasedependent cytochrome release, which suppresses the apoptotic pathways of cancer cells and makes cancer more resistant to chemotherapy.³

When glucose is scarce, the body senses the need to make an alternative form of energy for cells. The liver then produces ketones and fatty acids, which provide for normal cells but do not benefit cancer cells. Cancer cells have dysfunctional mitochondria and possibly electron transport chain defects, which disrupt normal adenosine triphosphate (ATP) production from the mitochondria. The result is that the cancer cells become heavily dependent on ATP coming from the less efficient process of glycolysis (Figure 1).

Ketogenic diets mimic the fasting state, wherein the body responds to the lack of glucose by producing ketones for energy. Excess lactate production, which is part of the Warburg effect, compensates for ATP production defects caused by dysfunctional mitochondrial oxidative phosphorylation.^2,4 The resulting tumor dependence on glucose can be exploited with KD use. Ketogenic diets selectively starve tumors by providing the fat and protein that otherwise could not be used by glucose-dependent tumor cells.

In KDs, the 4:1 ratio of high fat to low carbohydrates mimics the metabolic effects of starvation (Figure 2). These diets slow cancer by inhibiting insulin/IGF and downstream intracellular signaling pathways, such as

Ketogenic Diet Benefits

There are concerns about providing protein to patients who are at risk for renal problems. However, mouse models of diabetic nephropathy showed improved renal function with KD use. The hypothesis was that KD use, which produces prolonged elevated 3-β-hydroxybutyric acid levels, also reduces molecular responses to glucose and consequently reduces renal damage.⁶ Use of the diet also reduced pain and inflammation in both juvenile and adult rats. Mechanisms of action were thought to be reduced reactive oxygen species and increased central adenosine levels.^7,8

Adverse Effects

Dieting is of concern to cancer patients worried about additional weight loss. The standard diet is made up predominantly of carbohydrates and is high in caloric value (Figure 3). Beck and Tisdale investigated the effect of KD use on delaying cachexia in mouse models of colon carcinoma. They found that dieting was more effective than insulin in reversing weight loss and had the added effect of reducing tumor size.⁷ Moreover, Tisdale and colleagues found that KD use in cachectic cancer patients could promote weight gain.⁸

A possible explanation is that healthy tissue nutrition selectively delays tumor growth, while cancer cells are deprived of nutrition (carbohydrates). A therapeutic weight plateau should follow initial weight loss with KD, in contrast to pathologic rapid weight loss in non-KD patients.⁹ Kidney stones, gout, and symptomatic hypoglycemia were also potential expected adverse effects (AEs).

Case Reports

In 1962, the New York Department of Mental Hygiene published an article about 2 women whose metastatic cancers disappeared after a series of daily hypoglycemiainduced insulin comas (brief and reversible). These patients could not undergo conventional electric shock therapy, hence, the medically induced psychotherapy. Not only did their psychotic and depressive symptoms resolve, but their cancers (grossly visible cervical cancer and metastatic melanoma) became undetectable as early as 2 months into treatment.¹⁰ Zuccoli and colleagues reported on a glioblastoma that was effectively treated with temozolomide oral chemotherapy after the patient was weaned off steroids. The patient had a radiographic response and good tumor control for about a year, before discontinuing the diet. She transitioned to chemotherapy, which included bevacizumab (antivascular endothelial growth factor), but the disease progressed and she died.¹¹ In addition, during 8 weeks of ketogenic dieting, 2 pediatric female astrocytoma patients experienced improved mood and showed decreased glucose uptake on PET-computed tomography (PET-CT) of their tumor sites. One of these patients continued the diet and remained disease-free another 12 months.¹² These early case reports provide compelling evidence for further research into the role of glucose metabolism in cancer
treatment.

Current Research

Compared with normal mice, tumor-bearing mice placed on a low-carbohydrate diet had lower glucose, insulin, and lactic acid levels.⁴ An in vivo microdialysis study of patients with head and neck cancers found decreased lactic acid levels in the tumor tissues after a 4-day KD.¹³ Most early studies and case reports involving KD in cancer focused on brain tumors.^11,14-16 Human clinical studies on this diet in cancer care were limited to small, nonrandomized, brief trials (4-12 weeks) or single case studies (Table).^11,17-20

Fine and colleagues conducted a 4-week feasibility study of the low-carbohydrate modified Atkins KD (≤ 20 g of carbohydrates daily) in PET-positive advanced cancer patients with solid tumors. There was a correlation between insulin levels and ketosis but not IGF. Stable disease or partial remission (measured standardized uptake value) on PET-CT correlated with 3-fold higher ketosis (but not weight loss or reduced caloric intake) relative to patients with progressive disease.¹⁷ In the ERGO trial, Rieger and colleagues studied 20 relapsed glioblastoma patients who were on KD supplemented with plant oils.¹⁸ Calories were unlimited. The primary endpoint was percentage of patients who discontinued the diet. Mean weight loss was significant, but quality of life (QOL) was maintained. The investigators also studied the effects of KD alone or combined with bevacizumab in a mouse glioblastoma model. In this mouse study, KD alone had no effect; however, it increased median survival from 52 to 58 days (P < .05) with bevacizumab.

In a pilot study, Schmidt and colleagues provided KD plus oil-protein shakes as snacks to 7 of 16 patients with a variety of advanced metastatic cancers. Mean weight loss was statistically significant, blood lipid or cholesterol levels remained stable, some QOL measures improved, and there were no severe AEs.¹⁹ Schwartz and colleagues reviewed the cases of 32 glioma patients treated with energy restricted KDs —5 from case reports, 19 from a clinical trial by Rieger and colleagues, and 8 from Champ.^18,20,21 They also reported on 2 of their own glioma cases treated with the energy-restricted KD and studied tissues for expression of key ketolytic enzymes. Prolonged remission was noted from 4 months to more than 5 years in these case reports.²⁰

The VA Pittsburgh Healthcare System safety that trial enrolled 17 patients, 11 of whom were evaluated. Mean weight loss was significant, and weight loss of ≥ 10% was noted in responders (stable or improved disease) compared with nonresponders. Three patients dieted longer than 16 weeks (survival, 80-116 weeks). One of these patients was alive at 121 weeks.²²

The safety and feasibility data suggest that cancer patients can tolerate KD use. Investigators should consider combining the KD approach with standard treatment modalities, including chemotherapy and radiation.

Already investigators have conducted in vitro studies of the effect of gene expression of ketolytic and glycolytic enzymes within tumor tissue on KD response. Tumors expressing mutations in key mitochondrial oxidative phosphorylation enzymes were more likely to respond to KD use than were tumors without mutations.^16,23

Ongoing Clinical Trials

Duke University has initiated a randomized study (NCT00932672) of the Atkins diet and androgen deprivation therapy for patients with prostate cancer. Tel Aviv Sourasky Medical Center in Israel is recruiting previously treated chemoradiation patients with high-grade glial tumors for an open-label study (NCT01092247) of the efficacy of KD in preventing tumor growth and recurrence. St. Joseph’s Hospital and Medical Center (Phoenix, AZ) is recruiting newly diagnosed glioblastoma patients for a phase 1/2 prospective trial (NCT02046187) involving upfront resection followed by KD with radiotherapy and concurrent temozolomide, followed by adjuvant temozolomide chemotherapy. The primary endpoint is number of patients with AEs and the secondary endpoints are overall survival, time to progression, and QOL. The University of Iowa is recruiting patients with prostate cancer and non-small cell lung cancer for 2 phase 1 studies (NCT01419483 and NCT01419587, respectively) involving KD using Nutritia KetoCal 4:1 (Gaithersburg, MD).

Conclusion

Data from case reports and trials suggest KD use is safe and tolerable for patients with cancer. Although it would be ideal to conduct a larger trial using a randomized therapeutic approach, the current emphasis on drug-based trials is a formidable obstacle. Other major obstacles are patient initiative and adherence. For now, investigators must work with anecdotal data. Examination of gene expression patterns in mitochondria and mutations in ketolytic and glycolytic enzymes may prove useful in selecting potentially responsive patients. Combining this dietary approach with standard chemotherapeutic and radiotherapeutic options may help improve tumor response, and further research is desperately needed.

Click to read the digital edition.

As early as 500 bc , fasting was used as an effective treatment for many medical ailments. Fasting continued into modern times, and in 1910, Guelpa and Marie proposed fasting as an antiepilepsy treatment. In 1921, Woodyatt noted that starvation or use of high-fat, low-carbohydrate diets in individuals with no significant medical comorbidities yielded acetone and β-hydroxybutyrate, 2 energy sources produced by the liver in the absence of glucose. A low-carbohydrate, high-fat diet was thought to be an alternative to fasting or starvation, having many of the same desired effects while continuing to nourish healthy cells. The term ketogenic diet (KD) was later coined by Wilder and Peterman, who formulated the fat-to-carbohydrate ratio that is still used today: 1 g protein per kg of body weight in children and 10 to 15 g carbohydrates daily, and fat for the remainder of calories. Both investigators reported that this diet improved their patients’ mentation and cognition.¹

Use of the KD as an adjuvant to cancer therapy also began to emerge. In 1922, Braunstein noted that glucose disappeared from the urine of patients with diabetes after they were diagnosed with cancer, suggesting that glucose is recruited to cancerous areas where it is consumed at higher than normal rates. During that same time, Nobel laureate Otto Warburg found that cancer cells thrive on glycolysis, producing high lactate levels, even in the presence of abundant oxygen. Warburg conducted many in vitro and animal experiments demonstrating this outcome, known as the Warburg effect.

By the mid-20th century, KD use in epilepsy treatment and cancer research had waned. However, in the mid-to-late 1990s, with the establishment of the Charlie Foundation, the diet slowly started regaining recognition.¹ Results of many in vitro and animal studies were reported, and human data also began to accumulate.

Mechanism of Action

Glucose normally stimulates pancreatic β cells to release insulin, which allows glucose to enter cells and provide energy. With high carbohydrate and glucose intake, the pancreas increasingly secretes more insulin, which promotes the interaction of growth hormone receptors and growth hormones to produce insulin-like growth factor 1 (IGF-1) in the liver—promoting cell growth and proliferation, which can be detrimental to patients with cancer. Overexpression of glucose transporters 1 and 3 (Glut-1, Glut-3) also occurs in many cancers and corresponds to the degree of glucose uptake in aggressive tumors, as seen on positron emission tomography (PET).² Overexpression of hexokinase, the rate-limiting enzyme of glycolysis, further drives production of pyruvate and lactate, which cause reactive oxygen species damage. Translocation of the hexokinase rate-limiting enzyme from the cytosol into the outer mitochondrial membrane, where it interacts with voltage-dependent anion channels, can disrupt caspasedependent cytochrome release, which suppresses the apoptotic pathways of cancer cells and makes cancer more resistant to chemotherapy.³

When glucose is scarce, the body senses the need to make an alternative form of energy for cells. The liver then produces ketones and fatty acids, which provide for normal cells but do not benefit cancer cells. Cancer cells have dysfunctional mitochondria and possibly electron transport chain defects, which disrupt normal adenosine triphosphate (ATP) production from the mitochondria. The result is that the cancer cells become heavily dependent on ATP coming from the less efficient process of glycolysis (Figure 1).

Ketogenic diets mimic the fasting state, wherein the body responds to the lack of glucose by producing ketones for energy. Excess lactate production, which is part of the Warburg effect, compensates for ATP production defects caused by dysfunctional mitochondrial oxidative phosphorylation.^2,4 The resulting tumor dependence on glucose can be exploited with KD use. Ketogenic diets selectively starve tumors by providing the fat and protein that otherwise could not be used by glucose-dependent tumor cells.

In KDs, the 4:1 ratio of high fat to low carbohydrates mimics the metabolic effects of starvation (Figure 2). These diets slow cancer by inhibiting insulin/IGF and downstream intracellular signaling pathways, such as

Ketogenic Diet Benefits

There are concerns about providing protein to patients who are at risk for renal problems. However, mouse models of diabetic nephropathy showed improved renal function with KD use. The hypothesis was that KD use, which produces prolonged elevated 3-β-hydroxybutyric acid levels, also reduces molecular responses to glucose and consequently reduces renal damage.⁶ Use of the diet also reduced pain and inflammation in both juvenile and adult rats. Mechanisms of action were thought to be reduced reactive oxygen species and increased central adenosine levels.^7,8

Adverse Effects

Dieting is of concern to cancer patients worried about additional weight loss. The standard diet is made up predominantly of carbohydrates and is high in caloric value (Figure 3). Beck and Tisdale investigated the effect of KD use on delaying cachexia in mouse models of colon carcinoma. They found that dieting was more effective than insulin in reversing weight loss and had the added effect of reducing tumor size.⁷ Moreover, Tisdale and colleagues found that KD use in cachectic cancer patients could promote weight gain.⁸

A possible explanation is that healthy tissue nutrition selectively delays tumor growth, while cancer cells are deprived of nutrition (carbohydrates). A therapeutic weight plateau should follow initial weight loss with KD, in contrast to pathologic rapid weight loss in non-KD patients.⁹ Kidney stones, gout, and symptomatic hypoglycemia were also potential expected adverse effects (AEs).

Case Reports

In 1962, the New York Department of Mental Hygiene published an article about 2 women whose metastatic cancers disappeared after a series of daily hypoglycemiainduced insulin comas (brief and reversible). These patients could not undergo conventional electric shock therapy, hence, the medically induced psychotherapy. Not only did their psychotic and depressive symptoms resolve, but their cancers (grossly visible cervical cancer and metastatic melanoma) became undetectable as early as 2 months into treatment.¹⁰ Zuccoli and colleagues reported on a glioblastoma that was effectively treated with temozolomide oral chemotherapy after the patient was weaned off steroids. The patient had a radiographic response and good tumor control for about a year, before discontinuing the diet. She transitioned to chemotherapy, which included bevacizumab (antivascular endothelial growth factor), but the disease progressed and she died.¹¹ In addition, during 8 weeks of ketogenic dieting, 2 pediatric female astrocytoma patients experienced improved mood and showed decreased glucose uptake on PET-computed tomography (PET-CT) of their tumor sites. One of these patients continued the diet and remained disease-free another 12 months.¹² These early case reports provide compelling evidence for further research into the role of glucose metabolism in cancer
treatment.

Current Research

Compared with normal mice, tumor-bearing mice placed on a low-carbohydrate diet had lower glucose, insulin, and lactic acid levels.⁴ An in vivo microdialysis study of patients with head and neck cancers found decreased lactic acid levels in the tumor tissues after a 4-day KD.¹³ Most early studies and case reports involving KD in cancer focused on brain tumors.^11,14-16 Human clinical studies on this diet in cancer care were limited to small, nonrandomized, brief trials (4-12 weeks) or single case studies (Table).^11,17-20

Fine and colleagues conducted a 4-week feasibility study of the low-carbohydrate modified Atkins KD (≤ 20 g of carbohydrates daily) in PET-positive advanced cancer patients with solid tumors. There was a correlation between insulin levels and ketosis but not IGF. Stable disease or partial remission (measured standardized uptake value) on PET-CT correlated with 3-fold higher ketosis (but not weight loss or reduced caloric intake) relative to patients with progressive disease.¹⁷ In the ERGO trial, Rieger and colleagues studied 20 relapsed glioblastoma patients who were on KD supplemented with plant oils.¹⁸ Calories were unlimited. The primary endpoint was percentage of patients who discontinued the diet. Mean weight loss was significant, but quality of life (QOL) was maintained. The investigators also studied the effects of KD alone or combined with bevacizumab in a mouse glioblastoma model. In this mouse study, KD alone had no effect; however, it increased median survival from 52 to 58 days (P < .05) with bevacizumab.

In a pilot study, Schmidt and colleagues provided KD plus oil-protein shakes as snacks to 7 of 16 patients with a variety of advanced metastatic cancers. Mean weight loss was statistically significant, blood lipid or cholesterol levels remained stable, some QOL measures improved, and there were no severe AEs.¹⁹ Schwartz and colleagues reviewed the cases of 32 glioma patients treated with energy restricted KDs —5 from case reports, 19 from a clinical trial by Rieger and colleagues, and 8 from Champ.^18,20,21 They also reported on 2 of their own glioma cases treated with the energy-restricted KD and studied tissues for expression of key ketolytic enzymes. Prolonged remission was noted from 4 months to more than 5 years in these case reports.²⁰

The VA Pittsburgh Healthcare System safety that trial enrolled 17 patients, 11 of whom were evaluated. Mean weight loss was significant, and weight loss of ≥ 10% was noted in responders (stable or improved disease) compared with nonresponders. Three patients dieted longer than 16 weeks (survival, 80-116 weeks). One of these patients was alive at 121 weeks.²²

The safety and feasibility data suggest that cancer patients can tolerate KD use. Investigators should consider combining the KD approach with standard treatment modalities, including chemotherapy and radiation.

Already investigators have conducted in vitro studies of the effect of gene expression of ketolytic and glycolytic enzymes within tumor tissue on KD response. Tumors expressing mutations in key mitochondrial oxidative phosphorylation enzymes were more likely to respond to KD use than were tumors without mutations.^16,23

Ongoing Clinical Trials

Duke University has initiated a randomized study (NCT00932672) of the Atkins diet and androgen deprivation therapy for patients with prostate cancer. Tel Aviv Sourasky Medical Center in Israel is recruiting previously treated chemoradiation patients with high-grade glial tumors for an open-label study (NCT01092247) of the efficacy of KD in preventing tumor growth and recurrence. St. Joseph’s Hospital and Medical Center (Phoenix, AZ) is recruiting newly diagnosed glioblastoma patients for a phase 1/2 prospective trial (NCT02046187) involving upfront resection followed by KD with radiotherapy and concurrent temozolomide, followed by adjuvant temozolomide chemotherapy. The primary endpoint is number of patients with AEs and the secondary endpoints are overall survival, time to progression, and QOL. The University of Iowa is recruiting patients with prostate cancer and non-small cell lung cancer for 2 phase 1 studies (NCT01419483 and NCT01419587, respectively) involving KD using Nutritia KetoCal 4:1 (Gaithersburg, MD).

Conclusion

Data from case reports and trials suggest KD use is safe and tolerable for patients with cancer. Although it would be ideal to conduct a larger trial using a randomized therapeutic approach, the current emphasis on drug-based trials is a formidable obstacle. Other major obstacles are patient initiative and adherence. For now, investigators must work with anecdotal data. Examination of gene expression patterns in mitochondria and mutations in ketolytic and glycolytic enzymes may prove useful in selecting potentially responsive patients. Combining this dietary approach with standard chemotherapeutic and radiotherapeutic options may help improve tumor response, and further research is desperately needed.

Click to read the digital edition.

In 2012, staff at the Comprehensive Cancer Center of VA Connecticut Healthcare System in West Haven (VACHS) decided to create a template for a Cancer Survivorship Treatment Summary and Care Plan (Survivorship Care Plan [SCP] and treatment summary are used interchangeably in this article and refer to the same document) in the VACHS Computerized Patient Record System (CPRS) to be used as one component of a Multidisciplinary Cancer Survivorship Clinic. The clinic’s providers would be advanced practice registered nurses (APRNs), based in the Comprehensive Cancer Center of VACHS. This quality improvement project was created in response to the American College of Surgeons (ACoS) Commission on Cancer (CoC) Standard 3.3, effective January 1, 2012, which mandated that the cancer committee “develops and implements a process to disseminate a comprehensive care summary and follow-up plan to patients with cancer who are completing cancer treatment.”¹ According to ACoS CoC the process should be monitored, evaluated, presented, and documented at least annually to the cancer committee.

Creating the CPRS template took 9 months before the first SCPs were provided to patients in July 2013. Since that time, 210 SCPs have been provided to VACHS patients. Patient response was positive. Since implementation, patients have told their provider that they found the SCP’s list of signs and symptoms of cancer recurrence a helpful and reassuring resource.

Objective

This project is designed to be road map for other VA providers to follow by offering a review of the processes and resources that VACHS used and to share lessons learned.

The SCP is an important component of the survivorship standard of care. The CoC Standard 3.3 (version 2016) mandated that SCPs must be provided during an in-person meeting to an annually increasing percentage of patients initially diagnosed and treated for stage I, II, or III cancer in a given year—10% for those diagnosed and treated in 2015 and 25% for those diagnosed and treated in 2016 with increases in the required percentage each year thereafter. The mandated increase from 10% in 2015 to 25% in 2016 is significant and requires substantial resources to meet. Cancer centers seeking to achieve or maintain ACoS accreditation must fulfill this standard.²

It is important to establish a robust SCP process proactively. The percentage of SCPs provided that is mandated by the CoC continues to rise annually and the rate of survivorship also is expected to rise. The January 2016 CoC update clarified the phase-in of this standard over 4 years: (1) 2015: Implement a process to provide treatment summaries to at least 10% of patients treated for stage I-III cancer; (2) By end of 2016: Provide treatment summaries to at least 25% of eligible patients; (3) By end of 2017: Provide treatment summaries to at least 50% of eligible patients; and (4) By end of 2018: Provide treatment summaries to at least 75% of eligible patients.²

Background

In the fall of 2012, the project began with listening to survivors. The VA Survivorship Special Interest Group (SSIG) already had done significant work throughout the national VA system.3 The VACHS staff participated in monthly SSIG conference calls and reviewed the extensive resources created by its members, which is available through an internal VA website (Figure).

The VACHS staff reviewed the experiences of 2 VA sites using a draft CPRS survivorship care plan template. They also spent a day observing an established survivorship clinic at the VACHS academic affiliate Yale-New Haven Hospital (YNHH) in November of 2012. At that time, the YNHH clinic format was a 2-visit model for patients who had completed treatment. During their first visit to the YNHH clinic, patients meet with 4 members of an interdisciplinary team: a medical provider, a dietician, a physical therapist, and a social worker. At the end of the visit, the patient receives a SCP, a comprehensive document based on a template from the Livestrong organization.⁴ The second visit is scheduled 3 months later to follow up with patients and address any ongoing concerns. Patients then would be discharged from the survivorship clinic.

Given the complicated needs of the VA patient population, VACHS staff wanted to create a survivorship clinic that would provide regular, close followup by a multidisciplinary team within the existing hematology/oncology outpatient clinic. This design was believed to better serve veteran cancer survivors than a stand-alone clinic.

Clinic Creation

The VACHS chief of oncology, the cancer registrar, and the cancer care coordinator met in October 2012 to review Standard 3.3 and determine the best approach for VACHS patients. A plan to phase survivorship care into the existing hematology/oncology clinic was established. The group identified appropriate cancer survivor patients who would be followed by an APRN and a medical doctor. After reviewing the most common cancers treated at VACHS, it was decided to start the survivorship clinic with patients who had been treated for stage I lung cancer, stage I or II colorectal cancer, and/or stage I melanoma. These patients are not usually treated with chemotherapy, are less likely to relapse given early stage, and generally would be expected to be less complicated medically than would patients with more advanced disease. Patients previously treated for more advanced cancers would continue to be followed by medical doctors unless determined to be appropriate for migration to this new clinic.

The VACHS staff chose to embed this new clinic within existing APRN hematology/oncology clinics. Survivorship clinic visits were not restricted to a particular date or time in order to maximize efficiency as the workload associated with this clinic was not initially known. To track patient volume in the clinic, VACHS staff created the following note titles for patients being followed in the survivorship clinic: (1) Hem/Onc APRN Survivorship Clinic Initial Consult; (2) Hem/Onc APRN Cancer Survivorship Note; and (3) Cancer Survivor Treatment Summary. Unique note titles can be searched in VistA to create real-time reporting, thereby enabling staff to monitor the size, demographics, and workload associated with this clinic.

Vision for Care

The goals of survivorship care at VACHS were (1) to prevent, detect early, and treat complications from cancer treatment through regular clinic visits and ongoing education and support; (2) to provide holistic, individualized medical care and psychosocial support for veterans who are cancer survivors; (3) to maximize health, quality of life, and longevity; and (4) to facilitate appropriate referrals.

The VACHS clinic model incorporated: (1) regular clinic visits and follow-up with laboratories and imaging for 5 years, based on National Comprehensive Cancer Network (NCCN) guidelines; (2) monitoring for psychosocial distress at each visit, using a modified version of the NCCN Distress Thermometer, and a registered nurse or health tech documenting scores in CPRS with a templated Distress Screening note; (3) referrals to nutrition, health psychology, social work, physical therapy, smoking cessation, and the palliative care team as appropriate; (4) education about diagnosis, risk factors, and healthy living; and (5) reviewing the SCP to each patient.

The VACHS approach was designed to be patientcentered by incorporating individualized surveillance and screening guidelines, wellness education tailored to cancer type and treatment history, psychosocial support for survivors and their families through individual therapy and support groups for patients and families, and individual exercise and fitness recommendations through physical therapy and pulmonary rehabilitation referrals.

Needs Assessment

The VACHS cancer care coordinator worked with the tumor registrar to generate an initial referral patient list. Patients were identified in the tumor registry who met these criteria: diagnosed with stage I lung cancer or stage I or II colorectal cancer and treated at VACHS between 2008 and 2012. Initial research showed that there were 117 patients followed in the VACHS hematology/oncology clinic in the fall of 2012 who met the criteria. At that time, 80% of the patients identified were being followed by an attending oncology physician and 20% by an oncology APRN (Table).

Based on this initial analysis, the projected patient load for this clinic was anticipated to be 100 patients annually with between 2 and 4 annual visits each. Of note, in 2013 VACHS started a low-dose chest computed tomography screening program for patients who met high-risk criteria. The number of patients diagnosed and treated for stage I non-small cell lung cancer at VACHS during 2014 and 2015 was more than double the number treated in 2012.

Partnering With IT

The VACHS cancer care coordinator contacted the VISN 1 clinical application coordinator (CAC) in October 2012 who then reached out to her counterpart in Boston, where the sample CPRS template from the survivorship toolkit (toolkit template) was being tested. In November 2012, the VACHS CAC loaded the toolkit template into the test folder of the template drawer of VACHS CPRS. Changes were made over time to shorten the toolkit template to include the relevant information using the shortest number of words.

The template was modified by deleting 3 sections. The appointment list and the medication list were eliminated from the template as it was felt that these change with each visit. The psychosocial distress assessment also was eliminated as this score was known to change from visit to visit.

A separate initiative was undertaken simultaneously to address the need to monitor oncology patients for psychosocial distress regularly. Health psychology providers at VACHS used the NCCN Distress Thermometer to monitor distress in oncology patients. The team elected to take the distress assessment language out of the SCP and create a separate note template to record the distress scores for VACHS patients. The group chose the note titles Cancer Survivor Treatment Summary and Patient Distress Screening to clarify the purpose of the notes and to make searching CPRS or VistA for the note titles easier for providers or researchers.

CPRS Template Format

The VACHS team decided to create a short, clear, document that included diagnosis (date, location, pathology, staging), treatment (types, dates, locations, complications), disease-specific plan for surveillance, healthy living guidelines, and contact information for the survivorship provider.

The template was designed to be relatively simple for a provider to create, using check boxes that would populate the template with disease-specific care plans based on NCCN guidelines.

Review Process

The VACHS team’s original goal was to provide the first treatment summary to a patient on January 1, 2013, 10 weeks after the initial meeting with the CAC. This turned out to be overly optimistic. The VACHS Forms Committee meets once a month at VACHS. There is a formal review process for CPRS templates and all the decision makers must be present (Review Process Time Line).

The changes requested by the VACHS Forms Committee included taking out medications/appointments sections; spelling out all abbreviations; asking the educational coordinator to review educational portion of the template to make sure it complies with guidelines and reading level; and adding fields next to date of diagnosis field and, in every instance of treatment, dates for author to indicate where the diagnosis was made and where the treatment occurred.

Implementation

Starting with the list originally generated by the tumor registrar, the VACHS team set a goal of about 100 patients to be followed in an APRN survivorship clinic to focus on stage I lung cancer, stage I and II colorectal cancer, and stage I melanoma patients. As appropriate, patients were transitioned from being followed by a fellow or attending MD at the VACHS hematology/oncology clinic to the APRN survivorship clinic. As patients were seen in clinic for scheduled surveillance visits, the APRN survivorship clinic provider reviewed the process of creating a treatment summary with each patient and family as appropriate and reviewed their history with them in person to make sure that any complications related to treatment were identified. During each survivorship clinic visit, the provider verbally reviewed the plan for surveillance and signs and symptoms of recurrence to report to their clinician before providing the SCP to the patient.

Over the past 3 years, the VACHS Cancer Center has incorporated a hematology/oncology dietician, a health psychologist, a social worker, and a physical therapist into the outpatient clinic; all are usually available for sameday referrals. During regular survivorship visits, the survivorship APRN reviews any needs the veteran has and makes appropriate referrals. Palliative care personnel also are available in the cancer center during outpatient clinics for same-day consults. Survivorship patients are not automatically scheduled to see members of the team; rather, appropriate referrals are made via consults in CPRS after meeting with patients and assessing their needs.

In the past 3 years, 2 support groups were created, one for VACHS cancer center patients and one for caregivers. These groups are well attended by oncology and survivorship patients.

As part of the patient’s initial visit, the survivorship APRN reviews the patient’s information in CPRS and systematically reviews the original pathology, surgery, and tumor board notes as well as any notes related to treatments both within the VA system and in the community and creates the treatment summary CPRS note. In cases in which the patient had treatment at an outside facility, the patient signs a release of information form and original documentation of that treatment is requested. The completion of the SCP depends on the timing of when all appropriate information is available to be reviewed. As with all templates, minor editing is done to create the final note.

Once the survivorship APRN completes and signs the SCP, the patient’s primary care provider is added as a cosigner to the note. The patient receives the signed SCP at the visit. The January 2016 CoC Standard 3.3 update specifies that the SCP must be provided to the patient at an in-person visit and not mailed. As the SCP is a signed note in CPRS, it is easy to keep track of the date on which the information was reviewed and documented. If there are changes, such as a new cancer diagnoses or subsequent treatments, it is clear when the original information was documented. After providing the SCP to the patient and reviewing the document at an in-person meeting with the patient, the survivorship APRN documents the date that the SCP was provided to the patient in the progress note in CPRS. Once signed, the SCP is available to all providers within VACHS and able to be printed.

To date, 210 treatment summaries have been created for and provided to patients. Only 1 provider, the cancer care coordinator, is currently using the template, but use is not restricted. Patient feedback has been favorable: Patients state that the list of symptoms included in the treatment summary is useful. Patients report sharing the document with outside providers. The treatment summary also provides patients and families with a predictable plan for surveillance and regular in-person follow-up.

Patient Satsfaction Survey

In March 2015, VACHS conducted a patient satisfaction survey of 98 patients who had been provided with treatment summaries to better understand the impact on patients. This survey assessed quality measures, including patient’s confidence in their understanding of their cancer diagnosis, stage, treatment history, and plan for surveillance. Patient satisfaction with the resources available to them for healthy living also was measured, as was patient satisfaction with their survivorship and oncology providers and awareness that they had received a care plan.

Surveys were mailed to all VACHS survivorship patients for whom the treatment summaries were created who were still living and had not experienced a recurrence. The list of survey recipients was generated by searching VistA for the unique note title: Cancer Survivor Treatment Summary.

Sixty-six patients responded, a 67% response rate. The primary cancer diagnoses of the 66 study participants were lung (62.5%), colorectal (21.9%), melanoma (7.8%), head and neck (3.1%), and more than 1 malignancy (15.6%). Of the 66 respondents, 36.5% acknowledged receiving a treatment summary (23 patients).

Of those who acknowledge receiving a treatment summary, two-thirds stated that they have referred to the treatment summary for details about their diagnosis, treatment, plan for surveillance, and symptoms to report to practitioner. Between 73% and 76% were highly confident and between 22% and 25% were somewhat confident in their knowledge of their type of cancer, stage, treatment history and surveillance plan (> 90% positive response). The majority (66%) of patients were highly confident, and 32% were somewhat confident that there are resources available at VA to support their healthy lifestyle (98% positive response).

The survey also noted that 86% report being highly satisfied with care, and 92.4% are highly confident that their caregiver will provide compassionate care. Participants state that they have used the nutrition consults (38.5%), physical therapy (23%), health psychology (15.5%), smoking cessation (15.3%), and social work (10%). Of note, almost all those patients who reported using these services responded that they would recommend them.

Challenges

Despite the progress made at VACHS, there are significant challenges to meeting the CoC revised standard 3.3, which requires that 25% of patients treated with a stage I, II, or III cancer receive a Cancer Survivor Treatment Summary at an in-person visit in 2016. These relate primarily to multiple competing demands on provider time. In addition, 63.5% of patients who had been provided with a SCP at an in-person visit and responded to a satisfaction survey said they had not received the SCP. More research is needed to inform practice changes to optimize ongoing education and post-treatment care for veterans who are cancer survivors.

Conclusion

VA cancer centers seeking to ACoS CoC accreditation are required to provide a written summary of cancer treatment and plan for survivorship care to patients
diagnosed with at stage I, II, or III malignancy and treated at their facility. This requirement necessitates a significant ongoing investment in clinician and administrative workload to comply with the standard. The Comprehensive Cancer Center at VACHS, building on work by the SSIG, developed a concise note template in CPRS that enables oncology clinicians to create a treatment summary for each patient who meets criteria. During this process, VACHS has developed resources that may be useful to other VA cancer centers who are working to create this process. Clinicians interested in trialing the VACHS Cancer Survivor Treatment Summary template are encouraged to contact the author for additional information.

Visit www.fedprac.com/avahoupdates for an exclusive video interview with the author.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Acknowledgments
This project was a team effort. The author thanks the following VACHS colleagues for their input and support for this project: Michal Rose, MD, cancer center director; Donna Connery, tumor registrar; Renee Midgett, former clinical applications coordinator; Robert Troy Nall, health systems specialist; Forms Committee; Clarice Grens, APRN; and Jessica Barber, PhD, clinical psychologist as well as Members of VA Survivorship special interest group.

Click here to read the digital edition.

In 2012, staff at the Comprehensive Cancer Center of VA Connecticut Healthcare System in West Haven (VACHS) decided to create a template for a Cancer Survivorship Treatment Summary and Care Plan (Survivorship Care Plan [SCP] and treatment summary are used interchangeably in this article and refer to the same document) in the VACHS Computerized Patient Record System (CPRS) to be used as one component of a Multidisciplinary Cancer Survivorship Clinic. The clinic’s providers would be advanced practice registered nurses (APRNs), based in the Comprehensive Cancer Center of VACHS. This quality improvement project was created in response to the American College of Surgeons (ACoS) Commission on Cancer (CoC) Standard 3.3, effective January 1, 2012, which mandated that the cancer committee “develops and implements a process to disseminate a comprehensive care summary and follow-up plan to patients with cancer who are completing cancer treatment.”¹ According to ACoS CoC the process should be monitored, evaluated, presented, and documented at least annually to the cancer committee.

Creating the CPRS template took 9 months before the first SCPs were provided to patients in July 2013. Since that time, 210 SCPs have been provided to VACHS patients. Patient response was positive. Since implementation, patients have told their provider that they found the SCP’s list of signs and symptoms of cancer recurrence a helpful and reassuring resource.

Objective

This project is designed to be road map for other VA providers to follow by offering a review of the processes and resources that VACHS used and to share lessons learned.

The SCP is an important component of the survivorship standard of care. The CoC Standard 3.3 (version 2016) mandated that SCPs must be provided during an in-person meeting to an annually increasing percentage of patients initially diagnosed and treated for stage I, II, or III cancer in a given year—10% for those diagnosed and treated in 2015 and 25% for those diagnosed and treated in 2016 with increases in the required percentage each year thereafter. The mandated increase from 10% in 2015 to 25% in 2016 is significant and requires substantial resources to meet. Cancer centers seeking to achieve or maintain ACoS accreditation must fulfill this standard.²

It is important to establish a robust SCP process proactively. The percentage of SCPs provided that is mandated by the CoC continues to rise annually and the rate of survivorship also is expected to rise. The January 2016 CoC update clarified the phase-in of this standard over 4 years: (1) 2015: Implement a process to provide treatment summaries to at least 10% of patients treated for stage I-III cancer; (2) By end of 2016: Provide treatment summaries to at least 25% of eligible patients; (3) By end of 2017: Provide treatment summaries to at least 50% of eligible patients; and (4) By end of 2018: Provide treatment summaries to at least 75% of eligible patients.²

Background

In the fall of 2012, the project began with listening to survivors. The VA Survivorship Special Interest Group (SSIG) already had done significant work throughout the national VA system.3 The VACHS staff participated in monthly SSIG conference calls and reviewed the extensive resources created by its members, which is available through an internal VA website (Figure).

The VACHS staff reviewed the experiences of 2 VA sites using a draft CPRS survivorship care plan template. They also spent a day observing an established survivorship clinic at the VACHS academic affiliate Yale-New Haven Hospital (YNHH) in November of 2012. At that time, the YNHH clinic format was a 2-visit model for patients who had completed treatment. During their first visit to the YNHH clinic, patients meet with 4 members of an interdisciplinary team: a medical provider, a dietician, a physical therapist, and a social worker. At the end of the visit, the patient receives a SCP, a comprehensive document based on a template from the Livestrong organization.⁴ The second visit is scheduled 3 months later to follow up with patients and address any ongoing concerns. Patients then would be discharged from the survivorship clinic.

Given the complicated needs of the VA patient population, VACHS staff wanted to create a survivorship clinic that would provide regular, close followup by a multidisciplinary team within the existing hematology/oncology outpatient clinic. This design was believed to better serve veteran cancer survivors than a stand-alone clinic.

Clinic Creation

The VACHS chief of oncology, the cancer registrar, and the cancer care coordinator met in October 2012 to review Standard 3.3 and determine the best approach for VACHS patients. A plan to phase survivorship care into the existing hematology/oncology clinic was established. The group identified appropriate cancer survivor patients who would be followed by an APRN and a medical doctor. After reviewing the most common cancers treated at VACHS, it was decided to start the survivorship clinic with patients who had been treated for stage I lung cancer, stage I or II colorectal cancer, and/or stage I melanoma. These patients are not usually treated with chemotherapy, are less likely to relapse given early stage, and generally would be expected to be less complicated medically than would patients with more advanced disease. Patients previously treated for more advanced cancers would continue to be followed by medical doctors unless determined to be appropriate for migration to this new clinic.

The VACHS staff chose to embed this new clinic within existing APRN hematology/oncology clinics. Survivorship clinic visits were not restricted to a particular date or time in order to maximize efficiency as the workload associated with this clinic was not initially known. To track patient volume in the clinic, VACHS staff created the following note titles for patients being followed in the survivorship clinic: (1) Hem/Onc APRN Survivorship Clinic Initial Consult; (2) Hem/Onc APRN Cancer Survivorship Note; and (3) Cancer Survivor Treatment Summary. Unique note titles can be searched in VistA to create real-time reporting, thereby enabling staff to monitor the size, demographics, and workload associated with this clinic.

Vision for Care

The goals of survivorship care at VACHS were (1) to prevent, detect early, and treat complications from cancer treatment through regular clinic visits and ongoing education and support; (2) to provide holistic, individualized medical care and psychosocial support for veterans who are cancer survivors; (3) to maximize health, quality of life, and longevity; and (4) to facilitate appropriate referrals.

The VACHS clinic model incorporated: (1) regular clinic visits and follow-up with laboratories and imaging for 5 years, based on National Comprehensive Cancer Network (NCCN) guidelines; (2) monitoring for psychosocial distress at each visit, using a modified version of the NCCN Distress Thermometer, and a registered nurse or health tech documenting scores in CPRS with a templated Distress Screening note; (3) referrals to nutrition, health psychology, social work, physical therapy, smoking cessation, and the palliative care team as appropriate; (4) education about diagnosis, risk factors, and healthy living; and (5) reviewing the SCP to each patient.

The VACHS approach was designed to be patientcentered by incorporating individualized surveillance and screening guidelines, wellness education tailored to cancer type and treatment history, psychosocial support for survivors and their families through individual therapy and support groups for patients and families, and individual exercise and fitness recommendations through physical therapy and pulmonary rehabilitation referrals.

Needs Assessment

The VACHS cancer care coordinator worked with the tumor registrar to generate an initial referral patient list. Patients were identified in the tumor registry who met these criteria: diagnosed with stage I lung cancer or stage I or II colorectal cancer and treated at VACHS between 2008 and 2012. Initial research showed that there were 117 patients followed in the VACHS hematology/oncology clinic in the fall of 2012 who met the criteria. At that time, 80% of the patients identified were being followed by an attending oncology physician and 20% by an oncology APRN (Table).

Based on this initial analysis, the projected patient load for this clinic was anticipated to be 100 patients annually with between 2 and 4 annual visits each. Of note, in 2013 VACHS started a low-dose chest computed tomography screening program for patients who met high-risk criteria. The number of patients diagnosed and treated for stage I non-small cell lung cancer at VACHS during 2014 and 2015 was more than double the number treated in 2012.

Partnering With IT

The VACHS cancer care coordinator contacted the VISN 1 clinical application coordinator (CAC) in October 2012 who then reached out to her counterpart in Boston, where the sample CPRS template from the survivorship toolkit (toolkit template) was being tested. In November 2012, the VACHS CAC loaded the toolkit template into the test folder of the template drawer of VACHS CPRS. Changes were made over time to shorten the toolkit template to include the relevant information using the shortest number of words.

The template was modified by deleting 3 sections. The appointment list and the medication list were eliminated from the template as it was felt that these change with each visit. The psychosocial distress assessment also was eliminated as this score was known to change from visit to visit.

A separate initiative was undertaken simultaneously to address the need to monitor oncology patients for psychosocial distress regularly. Health psychology providers at VACHS used the NCCN Distress Thermometer to monitor distress in oncology patients. The team elected to take the distress assessment language out of the SCP and create a separate note template to record the distress scores for VACHS patients. The group chose the note titles Cancer Survivor Treatment Summary and Patient Distress Screening to clarify the purpose of the notes and to make searching CPRS or VistA for the note titles easier for providers or researchers.

CPRS Template Format

The VACHS team decided to create a short, clear, document that included diagnosis (date, location, pathology, staging), treatment (types, dates, locations, complications), disease-specific plan for surveillance, healthy living guidelines, and contact information for the survivorship provider.

The template was designed to be relatively simple for a provider to create, using check boxes that would populate the template with disease-specific care plans based on NCCN guidelines.

Review Process

The VACHS team’s original goal was to provide the first treatment summary to a patient on January 1, 2013, 10 weeks after the initial meeting with the CAC. This turned out to be overly optimistic. The VACHS Forms Committee meets once a month at VACHS. There is a formal review process for CPRS templates and all the decision makers must be present (Review Process Time Line).

The changes requested by the VACHS Forms Committee included taking out medications/appointments sections; spelling out all abbreviations; asking the educational coordinator to review educational portion of the template to make sure it complies with guidelines and reading level; and adding fields next to date of diagnosis field and, in every instance of treatment, dates for author to indicate where the diagnosis was made and where the treatment occurred.

Implementation

Starting with the list originally generated by the tumor registrar, the VACHS team set a goal of about 100 patients to be followed in an APRN survivorship clinic to focus on stage I lung cancer, stage I and II colorectal cancer, and stage I melanoma patients. As appropriate, patients were transitioned from being followed by a fellow or attending MD at the VACHS hematology/oncology clinic to the APRN survivorship clinic. As patients were seen in clinic for scheduled surveillance visits, the APRN survivorship clinic provider reviewed the process of creating a treatment summary with each patient and family as appropriate and reviewed their history with them in person to make sure that any complications related to treatment were identified. During each survivorship clinic visit, the provider verbally reviewed the plan for surveillance and signs and symptoms of recurrence to report to their clinician before providing the SCP to the patient.

Over the past 3 years, the VACHS Cancer Center has incorporated a hematology/oncology dietician, a health psychologist, a social worker, and a physical therapist into the outpatient clinic; all are usually available for sameday referrals. During regular survivorship visits, the survivorship APRN reviews any needs the veteran has and makes appropriate referrals. Palliative care personnel also are available in the cancer center during outpatient clinics for same-day consults. Survivorship patients are not automatically scheduled to see members of the team; rather, appropriate referrals are made via consults in CPRS after meeting with patients and assessing their needs.

In the past 3 years, 2 support groups were created, one for VACHS cancer center patients and one for caregivers. These groups are well attended by oncology and survivorship patients.

As part of the patient’s initial visit, the survivorship APRN reviews the patient’s information in CPRS and systematically reviews the original pathology, surgery, and tumor board notes as well as any notes related to treatments both within the VA system and in the community and creates the treatment summary CPRS note. In cases in which the patient had treatment at an outside facility, the patient signs a release of information form and original documentation of that treatment is requested. The completion of the SCP depends on the timing of when all appropriate information is available to be reviewed. As with all templates, minor editing is done to create the final note.

Once the survivorship APRN completes and signs the SCP, the patient’s primary care provider is added as a cosigner to the note. The patient receives the signed SCP at the visit. The January 2016 CoC Standard 3.3 update specifies that the SCP must be provided to the patient at an in-person visit and not mailed. As the SCP is a signed note in CPRS, it is easy to keep track of the date on which the information was reviewed and documented. If there are changes, such as a new cancer diagnoses or subsequent treatments, it is clear when the original information was documented. After providing the SCP to the patient and reviewing the document at an in-person meeting with the patient, the survivorship APRN documents the date that the SCP was provided to the patient in the progress note in CPRS. Once signed, the SCP is available to all providers within VACHS and able to be printed.

To date, 210 treatment summaries have been created for and provided to patients. Only 1 provider, the cancer care coordinator, is currently using the template, but use is not restricted. Patient feedback has been favorable: Patients state that the list of symptoms included in the treatment summary is useful. Patients report sharing the document with outside providers. The treatment summary also provides patients and families with a predictable plan for surveillance and regular in-person follow-up.

Patient Satsfaction Survey

In March 2015, VACHS conducted a patient satisfaction survey of 98 patients who had been provided with treatment summaries to better understand the impact on patients. This survey assessed quality measures, including patient’s confidence in their understanding of their cancer diagnosis, stage, treatment history, and plan for surveillance. Patient satisfaction with the resources available to them for healthy living also was measured, as was patient satisfaction with their survivorship and oncology providers and awareness that they had received a care plan.

Surveys were mailed to all VACHS survivorship patients for whom the treatment summaries were created who were still living and had not experienced a recurrence. The list of survey recipients was generated by searching VistA for the unique note title: Cancer Survivor Treatment Summary.

Sixty-six patients responded, a 67% response rate. The primary cancer diagnoses of the 66 study participants were lung (62.5%), colorectal (21.9%), melanoma (7.8%), head and neck (3.1%), and more than 1 malignancy (15.6%). Of the 66 respondents, 36.5% acknowledged receiving a treatment summary (23 patients).

Of those who acknowledge receiving a treatment summary, two-thirds stated that they have referred to the treatment summary for details about their diagnosis, treatment, plan for surveillance, and symptoms to report to practitioner. Between 73% and 76% were highly confident and between 22% and 25% were somewhat confident in their knowledge of their type of cancer, stage, treatment history and surveillance plan (> 90% positive response). The majority (66%) of patients were highly confident, and 32% were somewhat confident that there are resources available at VA to support their healthy lifestyle (98% positive response).

The survey also noted that 86% report being highly satisfied with care, and 92.4% are highly confident that their caregiver will provide compassionate care. Participants state that they have used the nutrition consults (38.5%), physical therapy (23%), health psychology (15.5%), smoking cessation (15.3%), and social work (10%). Of note, almost all those patients who reported using these services responded that they would recommend them.

Challenges

Despite the progress made at VACHS, there are significant challenges to meeting the CoC revised standard 3.3, which requires that 25% of patients treated with a stage I, II, or III cancer receive a Cancer Survivor Treatment Summary at an in-person visit in 2016. These relate primarily to multiple competing demands on provider time. In addition, 63.5% of patients who had been provided with a SCP at an in-person visit and responded to a satisfaction survey said they had not received the SCP. More research is needed to inform practice changes to optimize ongoing education and post-treatment care for veterans who are cancer survivors.

Conclusion

VA cancer centers seeking to ACoS CoC accreditation are required to provide a written summary of cancer treatment and plan for survivorship care to patients
diagnosed with at stage I, II, or III malignancy and treated at their facility. This requirement necessitates a significant ongoing investment in clinician and administrative workload to comply with the standard. The Comprehensive Cancer Center at VACHS, building on work by the SSIG, developed a concise note template in CPRS that enables oncology clinicians to create a treatment summary for each patient who meets criteria. During this process, VACHS has developed resources that may be useful to other VA cancer centers who are working to create this process. Clinicians interested in trialing the VACHS Cancer Survivor Treatment Summary template are encouraged to contact the author for additional information.

Visit www.fedprac.com/avahoupdates for an exclusive video interview with the author.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Acknowledgments
This project was a team effort. The author thanks the following VACHS colleagues for their input and support for this project: Michal Rose, MD, cancer center director; Donna Connery, tumor registrar; Renee Midgett, former clinical applications coordinator; Robert Troy Nall, health systems specialist; Forms Committee; Clarice Grens, APRN; and Jessica Barber, PhD, clinical psychologist as well as Members of VA Survivorship special interest group.

Click here to read the digital edition.

In 2012, staff at the Comprehensive Cancer Center of VA Connecticut Healthcare System in West Haven (VACHS) decided to create a template for a Cancer Survivorship Treatment Summary and Care Plan (Survivorship Care Plan [SCP] and treatment summary are used interchangeably in this article and refer to the same document) in the VACHS Computerized Patient Record System (CPRS) to be used as one component of a Multidisciplinary Cancer Survivorship Clinic. The clinic’s providers would be advanced practice registered nurses (APRNs), based in the Comprehensive Cancer Center of VACHS. This quality improvement project was created in response to the American College of Surgeons (ACoS) Commission on Cancer (CoC) Standard 3.3, effective January 1, 2012, which mandated that the cancer committee “develops and implements a process to disseminate a comprehensive care summary and follow-up plan to patients with cancer who are completing cancer treatment.”¹ According to ACoS CoC the process should be monitored, evaluated, presented, and documented at least annually to the cancer committee.

Creating the CPRS template took 9 months before the first SCPs were provided to patients in July 2013. Since that time, 210 SCPs have been provided to VACHS patients. Patient response was positive. Since implementation, patients have told their provider that they found the SCP’s list of signs and symptoms of cancer recurrence a helpful and reassuring resource.

Objective

This project is designed to be road map for other VA providers to follow by offering a review of the processes and resources that VACHS used and to share lessons learned.

The SCP is an important component of the survivorship standard of care. The CoC Standard 3.3 (version 2016) mandated that SCPs must be provided during an in-person meeting to an annually increasing percentage of patients initially diagnosed and treated for stage I, II, or III cancer in a given year—10% for those diagnosed and treated in 2015 and 25% for those diagnosed and treated in 2016 with increases in the required percentage each year thereafter. The mandated increase from 10% in 2015 to 25% in 2016 is significant and requires substantial resources to meet. Cancer centers seeking to achieve or maintain ACoS accreditation must fulfill this standard.²

It is important to establish a robust SCP process proactively. The percentage of SCPs provided that is mandated by the CoC continues to rise annually and the rate of survivorship also is expected to rise. The January 2016 CoC update clarified the phase-in of this standard over 4 years: (1) 2015: Implement a process to provide treatment summaries to at least 10% of patients treated for stage I-III cancer; (2) By end of 2016: Provide treatment summaries to at least 25% of eligible patients; (3) By end of 2017: Provide treatment summaries to at least 50% of eligible patients; and (4) By end of 2018: Provide treatment summaries to at least 75% of eligible patients.²

Background

In the fall of 2012, the project began with listening to survivors. The VA Survivorship Special Interest Group (SSIG) already had done significant work throughout the national VA system.3 The VACHS staff participated in monthly SSIG conference calls and reviewed the extensive resources created by its members, which is available through an internal VA website (Figure).

The VACHS staff reviewed the experiences of 2 VA sites using a draft CPRS survivorship care plan template. They also spent a day observing an established survivorship clinic at the VACHS academic affiliate Yale-New Haven Hospital (YNHH) in November of 2012. At that time, the YNHH clinic format was a 2-visit model for patients who had completed treatment. During their first visit to the YNHH clinic, patients meet with 4 members of an interdisciplinary team: a medical provider, a dietician, a physical therapist, and a social worker. At the end of the visit, the patient receives a SCP, a comprehensive document based on a template from the Livestrong organization.⁴ The second visit is scheduled 3 months later to follow up with patients and address any ongoing concerns. Patients then would be discharged from the survivorship clinic.

Given the complicated needs of the VA patient population, VACHS staff wanted to create a survivorship clinic that would provide regular, close followup by a multidisciplinary team within the existing hematology/oncology outpatient clinic. This design was believed to better serve veteran cancer survivors than a stand-alone clinic.

Clinic Creation

The VACHS chief of oncology, the cancer registrar, and the cancer care coordinator met in October 2012 to review Standard 3.3 and determine the best approach for VACHS patients. A plan to phase survivorship care into the existing hematology/oncology clinic was established. The group identified appropriate cancer survivor patients who would be followed by an APRN and a medical doctor. After reviewing the most common cancers treated at VACHS, it was decided to start the survivorship clinic with patients who had been treated for stage I lung cancer, stage I or II colorectal cancer, and/or stage I melanoma. These patients are not usually treated with chemotherapy, are less likely to relapse given early stage, and generally would be expected to be less complicated medically than would patients with more advanced disease. Patients previously treated for more advanced cancers would continue to be followed by medical doctors unless determined to be appropriate for migration to this new clinic.

The VACHS staff chose to embed this new clinic within existing APRN hematology/oncology clinics. Survivorship clinic visits were not restricted to a particular date or time in order to maximize efficiency as the workload associated with this clinic was not initially known. To track patient volume in the clinic, VACHS staff created the following note titles for patients being followed in the survivorship clinic: (1) Hem/Onc APRN Survivorship Clinic Initial Consult; (2) Hem/Onc APRN Cancer Survivorship Note; and (3) Cancer Survivor Treatment Summary. Unique note titles can be searched in VistA to create real-time reporting, thereby enabling staff to monitor the size, demographics, and workload associated with this clinic.

Vision for Care

The goals of survivorship care at VACHS were (1) to prevent, detect early, and treat complications from cancer treatment through regular clinic visits and ongoing education and support; (2) to provide holistic, individualized medical care and psychosocial support for veterans who are cancer survivors; (3) to maximize health, quality of life, and longevity; and (4) to facilitate appropriate referrals.

The VACHS clinic model incorporated: (1) regular clinic visits and follow-up with laboratories and imaging for 5 years, based on National Comprehensive Cancer Network (NCCN) guidelines; (2) monitoring for psychosocial distress at each visit, using a modified version of the NCCN Distress Thermometer, and a registered nurse or health tech documenting scores in CPRS with a templated Distress Screening note; (3) referrals to nutrition, health psychology, social work, physical therapy, smoking cessation, and the palliative care team as appropriate; (4) education about diagnosis, risk factors, and healthy living; and (5) reviewing the SCP to each patient.

The VACHS approach was designed to be patientcentered by incorporating individualized surveillance and screening guidelines, wellness education tailored to cancer type and treatment history, psychosocial support for survivors and their families through individual therapy and support groups for patients and families, and individual exercise and fitness recommendations through physical therapy and pulmonary rehabilitation referrals.

Needs Assessment

The VACHS cancer care coordinator worked with the tumor registrar to generate an initial referral patient list. Patients were identified in the tumor registry who met these criteria: diagnosed with stage I lung cancer or stage I or II colorectal cancer and treated at VACHS between 2008 and 2012. Initial research showed that there were 117 patients followed in the VACHS hematology/oncology clinic in the fall of 2012 who met the criteria. At that time, 80% of the patients identified were being followed by an attending oncology physician and 20% by an oncology APRN (Table).

Based on this initial analysis, the projected patient load for this clinic was anticipated to be 100 patients annually with between 2 and 4 annual visits each. Of note, in 2013 VACHS started a low-dose chest computed tomography screening program for patients who met high-risk criteria. The number of patients diagnosed and treated for stage I non-small cell lung cancer at VACHS during 2014 and 2015 was more than double the number treated in 2012.

Partnering With IT

The VACHS cancer care coordinator contacted the VISN 1 clinical application coordinator (CAC) in October 2012 who then reached out to her counterpart in Boston, where the sample CPRS template from the survivorship toolkit (toolkit template) was being tested. In November 2012, the VACHS CAC loaded the toolkit template into the test folder of the template drawer of VACHS CPRS. Changes were made over time to shorten the toolkit template to include the relevant information using the shortest number of words.

The template was modified by deleting 3 sections. The appointment list and the medication list were eliminated from the template as it was felt that these change with each visit. The psychosocial distress assessment also was eliminated as this score was known to change from visit to visit.

A separate initiative was undertaken simultaneously to address the need to monitor oncology patients for psychosocial distress regularly. Health psychology providers at VACHS used the NCCN Distress Thermometer to monitor distress in oncology patients. The team elected to take the distress assessment language out of the SCP and create a separate note template to record the distress scores for VACHS patients. The group chose the note titles Cancer Survivor Treatment Summary and Patient Distress Screening to clarify the purpose of the notes and to make searching CPRS or VistA for the note titles easier for providers or researchers.

CPRS Template Format

The VACHS team decided to create a short, clear, document that included diagnosis (date, location, pathology, staging), treatment (types, dates, locations, complications), disease-specific plan for surveillance, healthy living guidelines, and contact information for the survivorship provider.

The template was designed to be relatively simple for a provider to create, using check boxes that would populate the template with disease-specific care plans based on NCCN guidelines.

Review Process

The VACHS team’s original goal was to provide the first treatment summary to a patient on January 1, 2013, 10 weeks after the initial meeting with the CAC. This turned out to be overly optimistic. The VACHS Forms Committee meets once a month at VACHS. There is a formal review process for CPRS templates and all the decision makers must be present (Review Process Time Line).

The changes requested by the VACHS Forms Committee included taking out medications/appointments sections; spelling out all abbreviations; asking the educational coordinator to review educational portion of the template to make sure it complies with guidelines and reading level; and adding fields next to date of diagnosis field and, in every instance of treatment, dates for author to indicate where the diagnosis was made and where the treatment occurred.

Implementation

Starting with the list originally generated by the tumor registrar, the VACHS team set a goal of about 100 patients to be followed in an APRN survivorship clinic to focus on stage I lung cancer, stage I and II colorectal cancer, and stage I melanoma patients. As appropriate, patients were transitioned from being followed by a fellow or attending MD at the VACHS hematology/oncology clinic to the APRN survivorship clinic. As patients were seen in clinic for scheduled surveillance visits, the APRN survivorship clinic provider reviewed the process of creating a treatment summary with each patient and family as appropriate and reviewed their history with them in person to make sure that any complications related to treatment were identified. During each survivorship clinic visit, the provider verbally reviewed the plan for surveillance and signs and symptoms of recurrence to report to their clinician before providing the SCP to the patient.

Over the past 3 years, the VACHS Cancer Center has incorporated a hematology/oncology dietician, a health psychologist, a social worker, and a physical therapist into the outpatient clinic; all are usually available for sameday referrals. During regular survivorship visits, the survivorship APRN reviews any needs the veteran has and makes appropriate referrals. Palliative care personnel also are available in the cancer center during outpatient clinics for same-day consults. Survivorship patients are not automatically scheduled to see members of the team; rather, appropriate referrals are made via consults in CPRS after meeting with patients and assessing their needs.

In the past 3 years, 2 support groups were created, one for VACHS cancer center patients and one for caregivers. These groups are well attended by oncology and survivorship patients.

As part of the patient’s initial visit, the survivorship APRN reviews the patient’s information in CPRS and systematically reviews the original pathology, surgery, and tumor board notes as well as any notes related to treatments both within the VA system and in the community and creates the treatment summary CPRS note. In cases in which the patient had treatment at an outside facility, the patient signs a release of information form and original documentation of that treatment is requested. The completion of the SCP depends on the timing of when all appropriate information is available to be reviewed. As with all templates, minor editing is done to create the final note.

Once the survivorship APRN completes and signs the SCP, the patient’s primary care provider is added as a cosigner to the note. The patient receives the signed SCP at the visit. The January 2016 CoC Standard 3.3 update specifies that the SCP must be provided to the patient at an in-person visit and not mailed. As the SCP is a signed note in CPRS, it is easy to keep track of the date on which the information was reviewed and documented. If there are changes, such as a new cancer diagnoses or subsequent treatments, it is clear when the original information was documented. After providing the SCP to the patient and reviewing the document at an in-person meeting with the patient, the survivorship APRN documents the date that the SCP was provided to the patient in the progress note in CPRS. Once signed, the SCP is available to all providers within VACHS and able to be printed.

To date, 210 treatment summaries have been created for and provided to patients. Only 1 provider, the cancer care coordinator, is currently using the template, but use is not restricted. Patient feedback has been favorable: Patients state that the list of symptoms included in the treatment summary is useful. Patients report sharing the document with outside providers. The treatment summary also provides patients and families with a predictable plan for surveillance and regular in-person follow-up.

Patient Satsfaction Survey

In March 2015, VACHS conducted a patient satisfaction survey of 98 patients who had been provided with treatment summaries to better understand the impact on patients. This survey assessed quality measures, including patient’s confidence in their understanding of their cancer diagnosis, stage, treatment history, and plan for surveillance. Patient satisfaction with the resources available to them for healthy living also was measured, as was patient satisfaction with their survivorship and oncology providers and awareness that they had received a care plan.

Surveys were mailed to all VACHS survivorship patients for whom the treatment summaries were created who were still living and had not experienced a recurrence. The list of survey recipients was generated by searching VistA for the unique note title: Cancer Survivor Treatment Summary.

Sixty-six patients responded, a 67% response rate. The primary cancer diagnoses of the 66 study participants were lung (62.5%), colorectal (21.9%), melanoma (7.8%), head and neck (3.1%), and more than 1 malignancy (15.6%). Of the 66 respondents, 36.5% acknowledged receiving a treatment summary (23 patients).

Of those who acknowledge receiving a treatment summary, two-thirds stated that they have referred to the treatment summary for details about their diagnosis, treatment, plan for surveillance, and symptoms to report to practitioner. Between 73% and 76% were highly confident and between 22% and 25% were somewhat confident in their knowledge of their type of cancer, stage, treatment history and surveillance plan (> 90% positive response). The majority (66%) of patients were highly confident, and 32% were somewhat confident that there are resources available at VA to support their healthy lifestyle (98% positive response).

The survey also noted that 86% report being highly satisfied with care, and 92.4% are highly confident that their caregiver will provide compassionate care. Participants state that they have used the nutrition consults (38.5%), physical therapy (23%), health psychology (15.5%), smoking cessation (15.3%), and social work (10%). Of note, almost all those patients who reported using these services responded that they would recommend them.

Challenges

Despite the progress made at VACHS, there are significant challenges to meeting the CoC revised standard 3.3, which requires that 25% of patients treated with a stage I, II, or III cancer receive a Cancer Survivor Treatment Summary at an in-person visit in 2016. These relate primarily to multiple competing demands on provider time. In addition, 63.5% of patients who had been provided with a SCP at an in-person visit and responded to a satisfaction survey said they had not received the SCP. More research is needed to inform practice changes to optimize ongoing education and post-treatment care for veterans who are cancer survivors.

Conclusion

VA cancer centers seeking to ACoS CoC accreditation are required to provide a written summary of cancer treatment and plan for survivorship care to patients
diagnosed with at stage I, II, or III malignancy and treated at their facility. This requirement necessitates a significant ongoing investment in clinician and administrative workload to comply with the standard. The Comprehensive Cancer Center at VACHS, building on work by the SSIG, developed a concise note template in CPRS that enables oncology clinicians to create a treatment summary for each patient who meets criteria. During this process, VACHS has developed resources that may be useful to other VA cancer centers who are working to create this process. Clinicians interested in trialing the VACHS Cancer Survivor Treatment Summary template are encouraged to contact the author for additional information.

Visit www.fedprac.com/avahoupdates for an exclusive video interview with the author.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Acknowledgments
This project was a team effort. The author thanks the following VACHS colleagues for their input and support for this project: Michal Rose, MD, cancer center director; Donna Connery, tumor registrar; Renee Midgett, former clinical applications coordinator; Robert Troy Nall, health systems specialist; Forms Committee; Clarice Grens, APRN; and Jessica Barber, PhD, clinical psychologist as well as Members of VA Survivorship special interest group.

Click here to read the digital edition.