Background
Cognitive-behavioral therapy for cancer distress (CBT-C) is the most rigorously tested treatment for cancer distress.1,2 This class of psychological treatment is cancer-specific and skills-based.2 Patients learn skills and the associated scientific foundation, empowering them to effectively challenge unhelpful thought patterns, improve associated maladaptive behaviors, self-manage symptom burden (eg, insomnia), reduce physiologic arousal (eg, muscle tension, heart rate), and improve communication skills to optimize social support. Rigorous randomized controlled trials (RCTs) of group-delivered CBT-C have replicated reduced psychological distress and improved biobehavioral outcomes beyond 10 years after diagnosis, inclusive of associations with cancer recurrence and survival.3–7 Treatments labeled as CBT-C that have been tested less rigorously and were not associated with replicated biobehavioral outcomes are not reviewed in this paper. Candidate mechanisms of biologic outcomes include adherence to cancer treatment, reduced tobacco use, increased physical activity, and improvements in biologic markers associated with cancer progression,8–14 supporting the potential of CBT-C to address the quadruple aim of healthcare.15
Despite this evidence, access to distress treatment remains a significant challenge even in comprehensive cancer centers, hindered by understaffing, staff turnover, and limitations of insurance coverage and costs.16,17 Pressures to implement CBT-C are growing, including evidence strength that dovetails nicely with the pressures of national guidelines and standards. Cancer care plans that fail to systematically screen for and treat distress are guideline-incongruent and can result in loss of accreditation by the American College of Surgeons Commission on Cancer.1 Although group-delivered CBT-C increases access and patient volumes, mitigates understaffing, and provides both professional and peer support, clinicians do need increased administrative time.
Toward solving these “real-world” implementation problems, we sought to adapt group-delivered CBT-C from the earlier-described “gold standard” trials as a component of interdisciplinary comprehensive cancer care. In this report, we describe the implementation process focused on (1) adaptation of RCT-derived CBT-C for real-world practice settings and (2) subsequent evaluation of practice-adapted CBT-C in a cohort of consecutively treated patients.
Patients and Methods
Study Setting and Design
The study was conducted in a large comprehensive cancer center and Department of Psychiatry and Psychology located independently within a large general academic medical center (county population, 154,000; 16.6% rural; www.ruralhealthinfo.org). Adjacent counties were classified as increasingly rural (34.5%–93.3%). Before study launch, unstandardized, individual cancer care services were available within the department of psychiatry and psychology.
The process of CBT-C adaptation used the Consolidated Framework for Implementation Research (CFIR)18 (see Table 1) to develop focus group interview probes to elicit implementation barriers and facilitators within the organization. A mixed-methods evaluation of CBT-C implementation success was designed using the RE-AIM QuEST framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance: Qualitative Evaluation for Systematic Translation),19 focused on reach and implementation components. This 3-phase study was reviewed and approved by the Mayo Clinic Institutional Review Board.
CFIR Constructs and Associated Implementation Strategies
Phase 1: Stakeholder Engagement and Adaptation of CBT-C Delivery
We engaged cancer care stakeholders (eg, medical oncology, radiation oncology, surgical oncology, nursing, social work, psychology, psychiatry, palliative care, internal medicine, business administration) using snowball sampling via open invitation to group presentations. Presentations served as focus groups and also disseminated the CBT-C evidence base and national accreditation policy on cancer distress management.20 The primary organizational value of Mayo Clinic21 was highlighted to illustrate alignment between the organization and CBT-C as the best-evidence treatment for patient distress (ie, alleviating unnecessary patient suffering).
The first stakeholder presentation was invited by the organization’s cancer survivorship special interest group, which included an offer for subsequent presentations to any interested group. Four oncology champions emerged to support CBT-C implementation and identified a broader base of stakeholders. Subsequently, secondary presentations were delivered to disease-oriented and discipline-specific practice groups and administrative committees, and a voluntary email listserv was created to provide updates and invite ongoing input. We delivered 11 invited presentations (eg, gynecologic oncology, chemotherapy nurses, clinical practice committee) and received emails from 40 individual cancer care clinicians.
Through these channels of engagement, a list of barriers and facilitators was developed (eg, number of sessions, accreditation standard, clinician and organization readiness for implementation across cancer clinics). The master list of barriers and facilitators was updated with each presentation, condensed into themes by the primary investigator (PI) and oncology champions, and used to inform initial CBT-C adaptations.
Phase 2: User Testing and Adaptation of CBT-C Content
Phase 2 overlapped with phase 1, focusing on therapist and patient user testing to inform CBT-C content adaptation. All therapists providing adult cancer care were invited to a free, 3-day standardized CBT-C training via a National Institutes of Health dissemination and implementation grant (PI: B.L. Andersen, Ohio State University)22 and to conduct preadaptation user testing of CBT-C components within their practice. Therapist eligibility criteria included (1) active cancer practice, (2) interest in receiving evidence-based CBT-C training, (3) interest in “field testing” CBT-C within their own practice, and (4) willingness to engage in CBT-C fidelity monitoring. All eligible therapists (n=4) accepted the invitation to participate and were included as study coinvestigators. Therapists included the study PI (board-certified clinical health psychologist in cancer psychology), 2 PhD clinical health psychology fellows, and 2 master’s degree psychologists with at least 10 years of experience. Patient users were invited to provide anonymous feedback on the usefulness of CBT-C components via their therapists.
Monthly meetings facilitated sharing clinical observations, understanding CBT-C implementation barriers and facilitators, and brainstorming CBT-C adaptations. Therapists participated in 2 half-day adaptation workshops led by the study PI. Workshop 1 centered on brainstorming the relative value of CBT-C components. Workshop 2 focused on (1) ranking the “most useful” CBT-C components and (2) listing “missing” components based on clinical experience.
Phase 3: Implementation of the Adapted CBT-C
After adaptation, manualized CBT-C was implemented as a component of comprehensive cancer care. Referring clinicians from disease-oriented oncology clinics (eg, brain, breast, head and neck, lung, gynecologic, lymphoma) ordered a “cancer stress management” consultation through the electronic health record, which included a psychological diagnostic evaluation and health behavior assessment. Distress screening protocols varied across referring groups. After consultation, eligible patients were invited to participate in CBT-C. All clinical and study-related CBT-C activities were overseen by the study PI, who served as a cofacilitator with every CBT-C therapist for >90% of total sessions.
Measures: Phase 3 – Implementation of Adapted CBT-C
Administrative Feasibility of CBT-C Delivery
The feasibility of delivering group CBT-C was defined as a mean group size of ≥3 patients, based on both greater number of patients served and billable services when compared with individual services.
Feasibility of Patient Recruitment and Retention
The feasibility of recruitment was defined as group size ≥2 at the first CBT-C group session, with the rationale of providing peer support as an advantage over individual services. Feasibility in terms of retention was defined as ≥66% of patients completing at least half of the sessions. Reach was defined as the number of patients enrolling in and completing CBT-C.
Feasibility of Oncology Collaboration
The feasibility of oncology collaboration was defined by emergence of ≥3 referring oncology groups (which are disease-specific within this academic institution), reflecting our goal to expand beyond breast oncology alone.
Patient Acceptability
Quantitative
Patients completed the following Institute for Healthcare Improvement survey question23: “Would you recommend this program to your friends and family?” An average score of ≥4 (4 = quite a bit; 5 = very much) was defined as acceptable (adapted to a 5-point Likert response set for survey consistency).
Qualitative
After CBT-C completion, patients completed open-ended feedback. Therapists independently reviewed feedback, generated qualitative themes in the context of their experience as cofacilitators, and then combined themes into a ranked list together.
Results
Phase 1: Stakeholder Engagement and Adaptation
Adaptation: CBT-C Delivery Within the Organization
The number of therapy sessions within gold standard RCT-derived interventions (ie, 10–26 sessions, 90–120 minutes each) was predicted to be the primary implementation barrier, confirmed by user testing in phase 2. Additional implementation barriers included integration into a complex organization with several operational systems (administrative and clinician perspectives), patient travel burden and geographic distance from the cancer center (clinician and patient perspectives), and desired adaptations to traditional delivery (eg, expanding to populations beyond female breast cancer).
Facilitators to CBT-C implementation were congruent with those commonly documented within the literature,18,24,25 most prominently clinician and administrator stakeholder engagement and investment in a collaborative, sustainable practice model. Other significant facilitators were implementation pressures from the national accreditation standard and increased access to psychological services. Free therapist training facilitated therapist investment.
Phase 2: User Testing and Adaptation of CBT-C Content
Adaptation: CBT-C Delivery
CBT-C was adapted based on stakeholder feedback in phases 1 and 2 (see timeline in Table 2). The number of sessions was reduced to 10, and then ultimately 5 (2-hour duration, total “dose” = 10 hours). Additional adaptations included broader eligibility criteria: (1) any type and stage of cancer, (2) active treatment or within 1 year of treatment completion, (3) prognosis ≥1 year predicted survival, and (4) desire to focus on living well with cancer. Unique to the literature, patients with advanced and chronic cancers were invited to participate if they did not meet exclusion criteria, disclosing that some group members would be pursuing cure.
Timeline: CBT-C Stakeholder Engagement, Adaptation, and Implementation
Exclusion criteria centered on recommending the best treatment for each individual patient: (1) severe psychiatric disorder or chronic trait negative affect (not treated by CBT-C); (2) patient goals focused on end of life or existential distress (not addressed by CBT-C); (3) inability to contribute to a healthy interpersonal group dynamic (potential psychological harm to other group members); and (4) inability to sustain interactive participation for 2-hour sessions (most commonly due to fatigue or cognitive disorder). When the best treatment path was unclear, the patient was deemed eligible and offered a tailored menu of treatment options to consider.
Adaptation: CBT-C Content
Five key CBT-C content domains were identified for the organizational practice setting based on therapist- and patient-user testing: (1) cognitive appraisal, distortion, and reappraisal; (2) problem-solving/coping strategies26; (3) health behavior change for symptom management27,28; (4) assertive communication and social cognitive processing29–31; and (5) relaxation skill development.32 Sexual health and disease-specific education were excluded to reduce content.
Two additional evidence-based components were added from more recent “third-wave” psychological therapies, based on therapist-stakeholder judgment of clinical utility: (1) a values clarification exercise identifying each patient’s top 6 life values to increase relevancy/motivation for skill practice33 (eg, faith: integrate diaphragmatic breathing practice into the rhythm of an existing faith ritual; family: conceptualize exercise as a family activity, rather than time away from family), and (2) a brief introduction to acceptance and mindfulness-based strategies to update coping skills content.34,35
Phase 3: Implementation of the Adapted CBT-C
Administrative Feasibility of CBT-C Delivery
Practice-adapted CBT-C met thresholds for financial feasibility per review of administrative data (≥3 patients/group; x=3.86; range, 2–9). All sessions were billed as a health behavior group under a cancer diagnosis. Two patients (3.3%) needed to inform their insurance company that health behavior codes are designed for coverage of physical, not mental, health conditions (eg, cancer), which resulted in approval of insurance coverage for at least one additional patient. Thus, 99 (99.0%) of 100 patients appeared to have sufficient insurance coverage.
Feasibility of Patient Recruitment and Retention
Per administrative data, 449 patients were scheduled for evaluation. Most patients were eligible, and 100 participated in the CBT-C group. If geographic distance had not been a barrier, an additional 43 patients would have had treatment access (Figure 1). Group size met the threshold for peer support relative to individual services, and 86% of participants completed ≥3 of 5 sessions, and 75% completed 5 of 5 sessions. Most patients participating in CBT-C (n=60 of 100) consented to use of personal data for the purpose of research (see Table 3), with a higher completion rate of 100% completing ≥3 of 5 sessions as scheduled.
Sociodemographic Characteristics of Research Participants (n=60)
Feasibility of Oncology Collaboration
Four stakeholder champions (3 MD, 1 RN) and an email listserv of 40 oncology clinicians, including 25 MD/MBBS, 5 APRN/CNP/PA, 3 social workers, and 7 RNs, met the threshold for feasible collaboration. The Cancer Education Center donated cancer-specific space, and 3 referring clinics integrated a flyer into existing nurse education visits.
Patient Acceptability
CBT-C acceptability was rated as ≥4 of 5 by 98.0% of research participants, indicating they would recommend CBT-C to family and friends (n=50 of 51; x=4.8/5.0). Missing survey data imputed at lowest and highest possible values yielded a range of 83.3% to 98.0%. When assuming a value ≥4 for patients who missed no more than the last session due to medical treatment/illness, the range increased to 93.3% to 98.0%. Qualitative analyses of open-ended patient feedback (see Table 4) yielded primary themes of (1) desire to establish CBT-C as standard of care, (2) high value of coping skills specific to cancer stress impacts, and (3) appreciation of combined oncopsychology expertise and peer support.
Implementation Evaluation
Through the 3-year implementation process, small refinements were made to optimize acceptability of the CBT-C treatment manual/patient workbook. Language, narratives, figures, and images were cultivated to be welcoming to patients with multiple cancer types and stages; adults of any age; LGBTQ+, racial, and ethnic diversity; rural dwellers; and men.
Discussion
Our study found that practice-adapted CBT-C (a billable, 5-session, 10-hour treatment “dose”) met thresholds for acceptability and feasibility as a component of comprehensive cancer care. More than 98% of patients indicated that they would recommend this clinical service to family and friends with cancer, demonstrating high patient satisfaction. Furthermore, both care access (number of patients receiving psychological care) and volume of billable services improved as a function of group versus individually delivered services, without increased clinical staff. Only 3.3% of patients reported difficulty with insurance coverage.
A significant strength of this study is extending the utility of CBT-C to patients of multiple cancer types and stages, recurrent and chronic/advanced cancers, rural dwellers, and mixed-gender groups. Gold standard RCTs have mostly treated women with breast cancer in tightly controlled, urban-metropolitan academic settings (www.ruralhealthinfo.org, 0.4%–1.35% rural counties) and either excluded or did not report results from rural survivors.3,5,36 Notably, rural populations are significantly underrepresented in the literature because they represent 21% of cancer survivors,37 with persistent and worsening disparities in cancer outcomes compared with urban peers.38–40 The launch of this service was the first opportunity for local patients (16.6% rural) and adjacent rural counties (34.5%, 35.9%, 47.4%, 51.8%, 64.5%, and 93.3% rural) to access CBT-C. The study sample was representative of census statistics for white race including adjacent counties (91.6% vs 82.5%, 86.7%, 93.4%, 94.3%, 96.9%, 97.3%) and catchment area (90.6%; census.gov). RCTs have found that traditional CBT-C is efficacious for men with prostate cancer, inclusive of Hispanic men41 and monolinguistic Spanish-speaking men when culturally adapted.42 Studies inclusive of Hispanic women with breast cancer also demonstrate CBT-C efficacy.12
Despite condensing content into 5 sessions, geographic distance was the primary implementation barrier, as reported by nearly one-third of patients who declined group CBT-C (17% of all eligible patients; Figure 1). CBT-C needs to be adapted for remote delivery (eg, telehealth, technology-assisted modalities, blended models of face-to-face and technology-assisted care delivery43,44). Scheduling around other time commitments was also cited as a barrier, which might be mitigated by remote delivery.
Integration of CBT-C into cancer care plans necessitates stakeholder engagement at multiple levels of healthcare delivery,1,45 which is facilitated by implementation science frameworks to build shared goals. Here, the CFIR framework drew stakeholders together around the common goals of meeting national accreditation standards and reducing unnecessary patient suffering. RE-AIM QuEST provided structured evaluation of implementation success. Additional incentives for CBT-C implementation might include external reimbursement structures and quality recognition with evidence of improved outcomes and cost containment for patients, organizations, and insurers.1,46–52 The gold standard RCTs were conducted as grant-funded randomized clinical trials without clinical infrastructure, in urban metropolitan centers, and without billed services, and ended at trial completion.3,5,36 In contrast, this intervention was conducted as a sustainable clinical service successfully connected to clinical orders, scheduling, space, billing, and documentation systems in a relatively rural area and continues to be maintained as a clinical service.
We used a stakeholder-engaged study design focused on best-evidence care, which is a key study strength. This is one of the first studies to describe the process of CBT-C adaptation for a specific practice setting, to evaluate implementation of adapted CBT-C as a billable clinical service, and to report results supporting the generalizability of CBT-C to the practice setting, inclusive of diverse oncology patients, oncology clinics, a large healthcare system, and insurance coverage. Finally, this study highlights the importance of “real-world” studies in estimating volunteer bias in research study sampling. Administrative data suggest that we can expect lower treatment visit completion rates for all patients versus research volunteer subsamples (here, 86% vs 100% completion).
Weaknesses of our study include reliance on a single healthcare system and lack of data on actual costs, reimbursement, and maintenance/sustainability,25,53 highlighting needs for future research. Although this is one of the first studies to include both males and females, males were underrepresented. In addition, education was identified as a treatment disparity factor. Patients with a college degree were overrepresented compared with surrounding county statistics (76.5% vs 22.4%–37.6%; www.census.gov). Lower education is associated with multiple indicators of social disadvantage and barriers to best-evidence care, including lack of health insurance and transportation to healthcare facilities due to underemployment.54,55 The growth of patient navigator services is especially important to mitigate these social determinants of health.56
Next, we plan to test the clinical effectiveness of CBT-C as a clinical service with standardized patient-reported distress outcomes, including comparisons between in-person and remotely delivered modalities to better meet rural needs and address the primary barrier of geographic distance from the cancer center.
Conclusions
CBT-C can be adapted from gold standard RCTs to billable practice settings and implemented successfully as a component of comprehensive cancer care. Such guideline-congruent care meets current accreditation mandates for cancer distress management. Expanding delivery platforms to include remotely delivered CBT-C holds significant promise for reducing documented disparities in treatment access for rural and other health disparity populations. Ultimately, successful dissemination of CBT-C to a broad range of patients with cancer will require support for systematic implementation research in billable practice settings from funding agencies, healthcare payers, and healthcare organizations.
Acknowledgments
The authors thank all our stakeholders in cancer care, including referring clinicians, administrators, appointment and desk staff, patients, and therapists who contributed to this study. The authors thank the American College of Surgeons Commission on Cancer for taking the lead in incentivizing psychological health as core to comprehensive cancer care, inspiring us to test the acceptability and feasibility of CBT-C in the clinical practice setting.
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