Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial.

BACKGROUND: Cancer survivors and their informal caregivers (family members, close friends) often experience significant impairments in health-related quality of life (HRQOL), including disruptions in psychological, physical, social, and spiritual well-being both during and after primary cancer treatment. The purpose of this in-progress pilot trial is to determine acceptability and preliminary efficacy (as reflected by effect sizes) of CBCT® (Cognitively-Based Compassion Training) compared with a cancer health education (CHE) attention control to improve the primary outcome of depressive symptoms and secondary outcomes of other HRQOL domains (e.g., anxiety, fatigue), biomarkers of inflammation and diurnal cortisol rhythm, and healthcare utilization-related outcomes in both cancer survivors and informal caregivers. METHODS: Forty dyads consisting of solid tumor survivors who have completed primary treatments (chemotherapy, radiation, surgery) and their informal caregivers, with at least one dyad member with ≥ mild depressive symptoms or anxiety, will be recruited from Tucson, Arizona, USA. Survivor-caregiver dyads will be randomized together to complete either CBCT or CHE. CBCT is a manualized, 8-week, group meditation-based intervention that starts with attention and mindfulness and builds to contemplative practices aimed at cultivating compassion to the self and others. The goal of CBCT is to challenge unexamined assumptions about feelings and behaviors, with a focus on generating spontaneous self-compassion and increased empathic responsiveness and compassion for others. CHE is an 8-week, manualized group intervention that provides cancer-specific education on various topics (e.g., cancer advocacy, survivorship wellness). Patient-reported HRQOL outcomes will be assessed before, immediately after (week 9), and 1 month after CBCT or CHE (week 13). At the same time points, stress-related biomarkers of inflammation (e.g., plasma interleukin-6) and saliva cortisol relevant for survivor and informal caregiver wellness and healthcare utilization will be measured. DISCUSSION: If CBCT shows acceptability, a larger trial will be warranted and appropriately powered to formally test the efficacy of this dyadic intervention. Interventions such as CBCT directed toward both survivors and caregivers may eventually fill a gap in supportive oncology care programs to improve HRQOL and healthcare utilization in both dyad members. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03459781 . Prospectively registered on 9 March 2018.

Feasibility of Cognitively-Based Compassion Training (CBCT) for breast cancer survivors: a randomized, wait list controlled pilot study.

PURPOSE: This study assessed the feasibility of a meditation-based program called Cognitively-Based Compassion Training (CBCT) with breast cancer survivors. Enrollment and participant satisfaction with a novel intervention, adherence to program requirements, and differences between the intervention group and wait list controls on self-report measures were also assessed. Additionally, cortisol, a stress-related endocrine biomarker, was assessed. METHODS: Participants (n = 33) were randomly assigned to CBCT or the wait list. CBCT provided eight weekly, 2-h classes and a "booster" CBCT session 4 weeks later. CBCT participants were expected to attend classes and meditate between classes at least three times per week. Pre-/post-intervention and follow-up questionnaires measured symptom change (depression, intrusive thoughts, perceived stress, fear of cancer recurrence, fatigue/vitality, loneliness, and quality of life). Saliva samples were collected at the same periods to assess the slope of diurnal cortisol activity. RESULTS: Enrollment, class attendance, home practice time, and patient satisfaction exceeded expectations. Compared to controls, post-intervention, the CBCT group showed suggestions of significant improvements in depression, avoidance of intrusive thoughts, functional impairment associated with fear of recurrence, mindfulness, and vitality/fatigue. At follow-up, less perceived stress and higher mindfulness were also significant in the CBCT group. No significant changes were observed on any other measure including diurnal cortisol activity. CONCLUSIONS: Within the limits of a pilot feasibility study, results suggest that CBCT is a feasible and highly satisfactory intervention potentially beneficial for the psychological well-being of breast cancer survivors. However, more comprehensive trials are needed to provide systematic evidence. RELEVANCE: CBCT may be very beneficial for improving depression and enhancing well-being during breast cancer survivorship.

IMPACT--Integrative Medicine PrimAry Care Trial: protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model.

BACKGROUND: Integrative medicine (IM) is a patient-centered, healing-oriented clinical paradigm that explicitly includes all appropriate therapeutic approaches whether they originate in conventional or complementary medicine (CM). While there is some evidence for the clinical and cost-effectiveness of IM practice models, the existing evidence base for IM depends largely on studies of individual CM therapies. This may in part be due to the methodological challenges inherent in evaluating a complex intervention (i.e., many interacting components applied flexibly and with tailoring) such as IM. METHODS/DESIGN: This study will use a combination of observational quantitative and qualitative methods to rigorously measure the health and healthcare utilization outcomes of the University of Arizona Integrative Health Center (UAIHC), an IM adult primary care clinic in Phoenix, Arizona. There are four groups of study participants. The primary group consists of clinic patients for whom clinical and cost outcomes will be tracked indicating the impact of the UAIHC clinic (n = 500). In addition to comparing outcomes pre/post clinic enrollment, where possible, these outcomes will be compared to those of two matched control groups, and for some self-report measures, to regional and national data. The second and third study groups consist of clinic patients (n = 180) and clinic personnel (n = 15-20) from whom fidelity data (i.e., data indicating the extent to which the IM practice model was implemented as planned) will be collected. These data will be analyzed to determine the exact nature of the intervention as implemented and to provide covariates to the outcomes analyses as the clinic evolves. The fourth group is made up of patients (n = 8) whose path through the clinic will be studied in detail using qualitative (periodic semi-structured interviews) methods. These data will be used to develop hypotheses regarding how the clinic works. DISCUSSION: The US health care system needs new models of care that are more patient-centered and empower patients to make positive lifestyle changes. These models have the potential to reduce the burden of chronic disease, lower the cost of healthcare, and offer a sustainable financial paradigm for our nation. This protocol has been designed to test whether the UAIHC can achieve this potential. TRIAL REGISTRATION: Clinical Trials.gov NCT01785485.

When a whole practice model is the intervention: developing fidelity evaluation components using program theory-driven science for an integrative medicine primary care clinic.

Integrative medicine (IM) is a clinical paradigm of whole person healthcare that combines appropriate conventional and complementary medicine (CM) treatments. Studies of integrative healthcare systems and theory-driven evaluations of IM practice models need to be undertaken. Two health services research methods can strengthen the validity of IM healthcare studies, practice theory, and fidelity evaluation. The University of Arizona Integrative Health Center (UAIHC) is a membership-supported integrative primary care clinic in Phoenix, AZ. A comparative effectiveness evaluation is being conducted to assess its clinical and cost outcomes. A process evaluation of the clinic's practice theory components assesses model fidelity for four purposes: (1) as a measure of intervention integrity to determine whether the practice model was delivered as intended; (2) to describe an integrative primary care clinic model as it is being developed and refined; (3) as potential covariates in the outcomes analyses, to assist in interpretation of findings, and for external validity and replication; and (4) to provide feedback for needed corrections and improvements of clinic operations over time. This paper provides a rationale for the use of practice theory and fidelity evaluation in studies of integrative practices and describes the approach and protocol used in fidelity evaluation of the UAIHC.