Design of the comprehensive outcomes for after Cancer Health (COACH) trial: A randomized, wait-list control digital health coaching intervention for cancer survivors.
Abstract
Background
There are an estimated 18.6 million cancer survivors representing approximately 5.4% of the United States (U.S.) population, projected to exceed 26 million by 2040. Due to advances in therapy, individuals with cancer are experiencing increased overall survival that is often accompanied by maintenance therapy and the management of treatment-related sequelae that can diminish overall quality-of-life (QOL) and well-being. An interprofessional team in partnership with Pack Health (now operating under Quest Diagnostics), designed a 6-month digital health coaching (DHC) intervention to improve health outcomes for cancer survivors, defined in this study as within one year of completion of primary therapy, including those with metastatic disease.
Methods
Up to 625 survivors with diverse tumor types across eight U.S. sites are enrolling in a randomized wait-list control trial. The DHC intervention combines 1:1 calls with digital outreach delivered by certified health coaches. Primary aims are to assess feasibility and acceptability of the intervention and its effect on health self-efficacy. Secondary and exploratory aims assess associations among clinical, patient-reported, wearable, and microbiome data. Comorbidities, psychosocial status, and lifestyle behaviors are included to identify interindividual variability in survivors' experiences and needs.
Conclusion
The development and implementation of this multi-site DHC intervention demonstrates leveraging an academic-industry partnership to deliver continued supportive care to cancer survivors. Outcomes will evaluate the feasibility of the DHC model to extend supportive care beyond clinical settings and address survivors' QOL and well-being. The COACH intervention is a potentially scalable model designed to meet the holistic needs of survivors.