Abstract: Intermountain Healthcare, a Utah-based, not-for-profit organization, co-sponsored a pilot study to evaluate potential benefits of early survivorship care by offering a treatment summary and survivorship care plan at the beginning of a patient’s cancer treatment instead of when adjuvant therapy was complete. Additional interventions included providing patients with self-care strategies, increasing the frequency of distress screening, and conducting formal assessment of patients’ financial concerns. Fifty-two patients with breast cancer participated in the study. Oncology nurse navigators prepared and reviewed the treatment summary and care plan with study participants and offered supportive interventions based on participants’ answers to two validated tools assessing distress and financial toxicity. Participants demonstrated increased cancer knowledge over time, though the findings were not statistically significant. Based on the insights gained from conducting the study, reviewing a treatment summary and survivorship care plan at the earliest opportunity may promote patients’ understanding of their diagnosis and treatment plan thereby supporting informed decision-making. Emotional and financial issues can be addressed proactively when patients’ distress and financial concerns are assessed early in patients’ oncology care. This pilot study demonstrated feasibility, and larger scale research could provide significant results leading to improvements in early cancer survivorship interventions.
Cancer survivorship interventions must evolve as the estimated 16.8 million cancer survivors in the United States continue to have unmet needs.1,2 Methods of addressing the physical, emotional, psychosocial, and financial issues related to a cancer diagnosis and treatments are greatly needed.
In the 2006 seminal report “From Cancer Patient to Cancer Survivor: Lost in Transition,”3 the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine (formerly the Institute of Medicine) encouraged health care providers to offer patients a summary of their cancer treatment and a care plan addressing surveillance guidelines and life after cancer. Since that time, accrediting agencies and professional organizations have endorsed or required a treatment summary and survivorship care plan (TSCP) be offered to patients completing cancer treatment given with curative intent.4,5
In 2012 the American College of Surgeons’ Commission on Cancer (ACoS CoC) introduced the delivery of a comprehensive TSCP as part of their accreditation standards6; the standards were revised in 20164 and again in 2019.7 Although the delivery of a TSCP is no longer a required component of the 2020 ACoS CoC accreditation standards, cancer programs are encouraged to continue providing patients with the document.7 The American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative certification program developed the Survivorship Care Compendium, a repository of best-practice tools and resources that oncology programs can use to improve survivorship care. The compendium identifies key components of survivorship care, categorizes barriers and solutions to implementing a survivorship program, and provides resources for measuring the impact of a survivorship program.5 Survivorship care is also addressed in the Centers for Medicare & Medicaid Services Oncology Care Model (OCM). The 5-year model (2016-2021) aims to improve the quality of cancer care by enacting innovative payment models and methods for delivering quality cancer care such as enhanced care coordination and providing patients with a detailed treatment care plan.8 Kline et al9 recorded perspectives from four of the practices participating in the OCM. Two practices indicated that they increased their nurse navigator workforce to help meet OCM requirements. Another practice reported barriers to implementing the care plan due to lack of electronic health record (EHR) integration.
Despite the support of national organizations, the efforts to standardize survivorship care through the use of TSCPs has yet to see desired results.10-13 Cited barriers to implementing TSCPs include the time required to prepare and deliver the plans, patients being unclear on benefits associated with receiving a TSCP,13 and the care plans not being designed for diverse populations and those with low health literacy.12 In a systematic review examining the benefits of TSCPs, Jacobsen et al14 concluded that TSCPs did not significantly affect health outcomes and had marginal effect on health care delivery. The diversity in study designs and suggestion that TSCPs alone could affect patient outcomes were listed as possibly confounding conclusions. More research is needed to identify best practices in the preparation and delivery of TSCPs.
Intermountain Healthcare co-sponsored a pilot study designed to improve the delivery of cancer survivorship care by providing patients with a TSCP at the initiation of treatment instead of solely at the conclusion of adjuvant therapy. Additional interventions included providing patients with self-care strategies, increasing the frequency of distress screening, and conducting formal assessment of patients’ financial concerns. This report provides lessons learned from conducting the study, including the perceptions of participants and health care professionals regarding the benefits of early survivorship interventions.
Setting and Pilot Study Design
All procedures performed were in accordance with the ethical standards of the institutional and/or national research committee for studies involving human participants and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
Intermountain Healthcare is a not-for-profit institution operating out of Salt Lake City, UT. Intermountain provides cancer care at six Utah-based cancer centers and to rural locations in Utah and Idaho through a robust teleoncology program. The study population was narrowed to breast cancer patients receiving care at Intermountain Cancer Center St. George and Cedar City; both facilities are located in southwestern Utah.
Intermountain oncology nurse navigators (ONN) follow a standardized patient care pathway (Figure 1). The pathway indicates key points in time when ONNs, social workers, financial advocates, and rehabilitation staff interact with oncology patients. When patients are referred to an Intermountain cancer center, they are contacted by an ONN who supports them through each stage of the cancer care continuum. ONNs meet with patients prior to a medical oncology consult to help facilitate any additional testing, answer patient and families’ questions, provide disease and treatment education, and address patients’ individual barriers to care. ONNs also prepare and review a TSCP with patients and families within one year of adjuvant therapy completion. In addition, ONNs discuss adjusting to life after cancer and assist patients in getting referrals to support services as needed. ONNs spent approximately one hour preparing the TSCP and one hour reviewing the document with patients and supporters. As part of the oncology patient care pathway, new oncology patients completed the National Comprehensive Cancer Network (NCCN) Distress Thermometer and Problem List for Patients15 prior to their medical oncology consult. ONNs use the distress scores to identify patient stressors and determine appropriate interventions. Other than the distress tool, no formal financial toxicity assessment was in place prior to the study.
Breast cancer patients who consented to participate in the study were randomized to those participants who received standard navigation services (as described above) and those who received standard navigation services, early introduction to the TSCP, and financial toxicity assessment. Participants in the intervention cohort were given a TSCP at key touchpoints: upon referral to medical oncology, once treatment plans were established, after any change in a patient’s treatment plan or modality, and at the completion of adjuvant therapy. The TSCP contained the same components as the ASCO treatment summary and care plan (Table 1).
ONNs reviewed the TSCP with participants to promote patient and family understanding of the diagnosis and treatment plan, reinforce verbal education, build upon prior education/knowledge, and promote awareness of self-care options. The TSCP provided an up-to-date view of patients’ cancer care and offered recommendations for self-care strategies and resources (ie, dietician, physical therapy). Participants were given an updated copy of their TSCP and encouraged to use the self-care strategies. Participants in the intervention cohort also completed the NCCN Distress Thermometer and the Comprehensive Score for Financial Toxicity (COST)16 financial assessment at each of the identified touchpoints. The NCCN Distress Thermometer recorded the degree of distress experienced by patients on a 0-10 value scale, with zero indicating no distress and 10 representing extreme distress. Participants’ response to the distress scale was recorded along with yes/no responses to a list of practical, emotional, family, and physical problems listed in the questionnaire. Participants’ perception of financial worry and burden were captured in the 12 questions in the COST survey. Question range from I know that I have enough money in savings, retirement, or assets to cover the costs of my treatment to I am concerned about keeping my job and income, including work at home. Participants responses were recorded on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much).
Both cohorts were asked to complete a survey when consenting to participate in the study and at the conclusion of active treatment. The survey questions evaluated the degree to which participants felt engaged in their care, actively joined in shared decision-making, and understood their diagnosis, treatment choices, and self-care options. The surveys were given on paper and entered into a REDCap database by a study assistant.
Data Analysis and Observations
Fifty-two patients with invasive breast cancer were enrolled in the study and 31 completed all study requirements. Participants ranged in age from 37 to 78 years with the average age of participants in the intervention and control groups being 63 years and 64 years, respectively. One male participant was included in the intervention cohort; the remainder of participants identified as female. The majority of participants had Medicare coverage (n=16) followed by private payers (n=11), Medicaid (n=1), VA (n=1), and two participants did not have any insurance coverage. Table 2 summarizes the characteristics of the study sample as a whole and by intervention and control groups.
Participants in both cohorts demonstrated increased knowledge related to their disease characteristics, treatments and side effects, and self-care options. Statistical significance was not observed in either cohort alone or comparatively. ONNs noted that a correct response to questions regarding stage of disease and receptor status did not signify that the participant understood the clinical significance of the information. However, participants’ answers to the survey prompted the ONN to assess patients’ understanding of their disease state and educate the patient and family in areas that were either unknown or incorrectly identified on the survey. ONNs reported that the time required to prepare the TSCP did not decrease, however, building the document incrementally fit better into their daily workflow.
Health care providers often rely on observation and intuition in order to assess patients’ understanding and reasoning related to their condition.17 When patients clearly understand the characteristics of their disease state and options for treatment, they can make informed decisions regarding their care. Although the survey prompted conversation between the study participant and the ONN, the survey’s overall relevance in the clinic setting appears to be negligible. It was determined that integrating a review of the patients’ TSCP at key touchpoints in the oncology patient care pathway would stimulate conversations between ONNs and patients regarding their disease state and recommended treatment modalities. Additionally, ONNs would encourage patients’ understanding of and accountability for using self-care strategies.
In the pilot study, all participants completed the distress tool at the medical oncology consult. Participants identified worry (n=18) and fear (n=10) as their most pressing psychosocial concerns whereas fatigue and sleep (n=13) were equally distressing to participants’ physical state. Participants received standard interventions including referral to social work and education on sleep hygiene and managing fatigue. ONNs also advocated with the patient for medicinal interventions, physical therapy referral, and sleep studies if indicated. The intervention cohort also completed the distress tool at each change in treatment modality. For example, after systemic therapy and prior to radiation therapy, however, only the initial and final distress scores of the intervention participants were used in the paired-samples t test analysis. Results showed that distress scores improved from diagnosis (mean 4.0, standard deviation [SD] 2.2) to end of active treatment conditions (mean 1.7, SD 1.7), P=.003. An advantage to more frequent assessment of distress screening was early identification of participants whose scores remained elevated as treatment progressed, potentially indicating the need for additional support and interventions. These findings led to the decision to add distress screening at two additional touchpoints in the oncology patient care pathway: change of treatment modality and end of treatment.
There was no formal financial assessment tool used prior to starting the pilot study. As part of the standard navigation barrier assessment, ONNs simply asked patients if they had any financial concerns. The study sought to evaluate the value of using the COST financial toxicity assessment tool. Participants in the intervention cohort completed the COST tool at specific touchpoints: initial consult with medical oncology, when the patient was changing treatment modalities, and at end of active treatment. Only the initial and end-of-treatment COST surveys were used in the analysis to account for those breast patients who did not have systemic therapy and therefore only completed two surveys. COST scores can range from 0-44 and were graded on the degree of impact to patient’s quality of life. Table 3 describes the grading and interventions used in the pilot study. COST scores (N=12) ranged from 0-25 (mean 12.1, SD 9.0) at the medical oncology consult and 0-22 (mean 8.1, SD 8.8) at end of treatment. Although decreases in COST results were noted between the initial and end-of-treatment survey results (P=.075), the time it took to complete and score the COST survey influenced the decision not to incorporate its use into the oncology care pathway. Financial concerns would continue to be assessed through the use of open-ended questions such as What financial concerns do you have at this time?
Integrating Early Survivorship Interventions Into a Patient Care Pathway
Prevention of and screening for unwanted physical, emotional, and financial toxicities should begin at diagnosis and extend through survivorship. Study results imply that frequent review of a TSCP can lead to enhanced understanding of the disease process and treatments, build upon prior education and knowledge, and promote patients’ motivation and accountability for using the self-care techniques included in the care plan.
Standardized patient care pathways lead to better communication between disciplines, judicious use of resources, and enhanced patient care.18 Formal and informal results from the pilot study prompted oncology program leaders to integrate a review of patients’ TSCP and self-care strategies, distress screening, and financial toxicity assessment at the following points in time: upon referral to medical oncology, at each change in treatment modality, and at end of treatment.
Patients and their families benefit from early interventions that support understanding of their diagnosis, treatment options, and associated side effects. When assessed early on, patient and family distress and financial concerns can be addressed, and further emotional and financial issues prevented. ONNs determined that review of the TSCP and self-care strategies helped support informed decision-making by empowering the patient with disease-based knowledge and personalized resources. At the end of active treatment, follow-up schedules for oncology and primary care providers (PCPs), surveillance guidelines, late and long-term side effects, and other pertinent information based on the patient’s treatment and current state of health were added to the TSCP.
Intervention participants completing the TSCP Use Survey unanimously rated the document as useful and indicated that they shared the information with family members. However, none of the participants indicated that they shared the document with their PCPs. Based on the responses (N=12), participants primarily used the TSCP to help make positive lifestyle changes. ONNs participating in the study determined that the TSCP was beneficial to patients early in their cancer care and aided ONNs in identifying knowledge gaps in those they were educating. ONNs identified that patients’ health goals were not part of the TSCP and asked that this section be added and that the document be renamed “Continuum of Care Plan.” Current work is underway to integrate a Continuum of Care Plan into the EHR.
None of the survey questions specifically evaluated patients’ perceptions on the amount of information given during the ONN education sessions. However, based on Constructivist Learning Theory, people learn by building upon prior knowledge.19 When a person is diagnosed with cancer, they may or may not have any prior knowledge of the disease, treatments, or long-term effects. The oncology team determined that review of the TSCP and self-care strategies as outlined in the study would enhance patient and family learning by adding to prior knowledge vs delivery of all of the information in the TSCP at the conclusion of adjuvant therapy.
Limitations
The pilot study was limited by sample size due to recruitment barriers that proved difficult to overcome, namely, the initiation of other survey-based trials accruing simultaneously and the pilot study not garnering physician support to the degree of the competing trials. Accrual to previous institution-based breast cancer studies met intended accrual, therefore, the lower than expected participation and low retention was surprising. In hindsight, the study design did not account for the variety in breast cancer treatment. Participants receiving surgical intervention, chemotherapy, and radiation treatments received more frequent assessments than participants who did not have chemotherapy. As a result, the data was not stratified. An adequately powered study could easily stratify and compare participants with similar courses of treatment. Additionally, a validated survey assessing patients’ knowledge of their disease, treatments, potential side effects, and use of self-care methods is warranted to adequately assess potential benefits associated with early survivorship care.
Conclusion
Distress screening and assessment for financial toxicity at key points in the cancer care continuum can enhance oncology providers’ ability to provide individualized education and resources while addressing patients’ needs in real time. As the number of cancer survivors continues to grow, research funding for larger studies addressing survivorship care at diagnosis and throughout the cancer care continuum is greatly needed.
References
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