Integrative Approaches for Cancer Survivorship: A Multi-Site Feasibility and Acceptability Study - PROJECT SUMMARY BACKGROUND: There are currently more than 4 million breast cancer survivors in the U.S., and an additional 287,000 will be diagnosed in 2022. Although the growing number of breast cancer survivors reflect advances in detection and treatment, the transition to post-treatment survivorship remains challenging. Patients are left with sequelae due to their cancer diagnosis and treatment resulting in impairments in quality of life (QOL) and an ongoing burden from cancer. Few safe and effective approaches currently exist to address this gap in care. We have developed and piloted integrative medicine interventions for cancer survivors including a personalized and patient-centered Mind and Body intervention based on Ayurvedic Medicine, which includes nutrition and lifestyle approaches, and an engaging and comprehensive health education intervention based on national survivorship guidelines. The two interventions are matched to each other for time and attention. Our prior research, conducted at a single site, has demonstrated that these two interventions are feasible and acceptable for cancer survivors and that randomization, retention, and adherence to these interventions was feasible. In these prior studies, we found that the Ayurvedic intervention showed promise of clinical benefit with patients showing moderate to large improvements in global health, sleep, fatigue, and mood. METHODS: Given the results of our research to date, we propose in this application to conduct key next steps in multi-site (sites at UCSF, Kaiser Permanente Northwest, and Vanderbilt University) intervention optimization, and feasibility and acceptability testing. This proposal will conduct two interlinked steps in a population of breast cancer patients, with the following specific aims: (1) To adapt and optimize the Ayurveda and Health Education interventions (1a) for implementation in a multi-site setting and (1b) improving recruitment and retention of underrepresented patients. (2) To determine the feasibility, acceptability, and fidelity of the integrative medicine survivorship interventions and study design in a multi-site setting. In Aim 2, we will conduct a three-arm pilot randomized controlled trial in which breast cancer survivors will be randomized (N=35 per arm) to one of the integrative medicine interventions along with usual care or usual care alone. This R01 study will help us to determine acceptability and feasibility of randomization, retention, adherence, and fidelity across the multi-site setting. SIGNIFICANCE: In the long-term, if this approach is shown to be effective, it has the potential to shift the paradigm in favor of emphasizing the importance of addressing symptoms, quality of life and wellbeing; the development of non-toxic and natural approaches for health; and a more patient-centered focus in healthcare.
