A multi-site trial of an electronic health integrated physical activity promotion intervention in breast and endometrial cancers survivors: MyActivity study protocol
Despite the known benefits of moderate-to-vigorous physical activity (MVPA) for breast and endometrial cancer survivors, most are insufficiently active, interventions response is heterogeneous, and MVPA programming integration into cancer care is limited. A stepped care approach, in which the least resource-intensive intervention is delivered first and additional components are added based on individual response, is one strategy to enhance uptake of physical activity programming. However, the most effective intervention augmentation strategies are unknown. In this singly randomized trial of post-treatment, inactive breast and endometrial cancer survivors (n = 323), participants receive a minimal intervention including a Fitbit linked with their clinic's patient portal and, in turn, the electronic health record (EHR) with weekly feedback delivered via the portal. MVPA progress summaries are sent to participants' oncology team via the EHR. MVPA adherence is evaluated at 4, 8, 12, 16 and 20 weeks; non-responders (those meeting ≤80% of the MVPA goal over previous 4 weeks) at each timepoint are randomized once for the remainder of the 24-week intervention to one of two "step-up" conditions: (1) online gym or (2) coaching calls, while responders continue with the minimal Fitbit+EHR intervention. The primary outcome is ActiGraph-measured MVPA at 24 and 48 weeks. Secondary outcomes include symptom burden and functional performance at 24 and 48 weeks. This trial will inform development of an effective, scalable, and tailored intervention for survivors by identifying non-responders and providing them with the intervention augmentations necessary to increase MVPA and improve health outcomes. Clinical Trials Registration # NCT04262180.
Journal
Contemporary Clinical TrialsAuthors
Funding
Novel Methods for Intensive Longitudinal Data in SMART Studies of Drug Abuse and HIVDesigning with Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer SurvivorsMulti-site adaptive trial of a technology-based, EHR-integrated physical activity intervention in breast and endometrial cancer survivorsSedentary Behavior and Breast Cancer: Interventions and BiomarkersUniversity of Wisconsin Institute for Clinical and Translational ResearchMI-SMART: Methods for Optimizing Multilevel Adaptive Implementation Strategies to Promote the Adoption of Effective SUD and HIV ServicesNational Institutes of Health FundingSedentary Behavior and Breast Cancer: Interventions and BiomarkersDesigning with Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer SurvivorsNational Cancer Institute Grant R37CA25877National Center for Advancing Translational Sciences Grant UL1TR002373