A multi-site trial of an electronic health integrated physical activity promotion intervention in breast and endometrial cancers survivors: MyActivity study protocol

Abstract

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.

Keywords: Adaptive intervention; Breast cancer; Digital health; Endometrial cancer; Physical activity; cancer survivorship.

Figure 1.. MyActivity Trial design

Provides a design overview of the study illustrating the interventional stages, follow-up period and timepoints for assessments.

Figure 2.. MyActivity Study Conceptual Model.

This model details how we hypothesize each intervention component influences MVPA. SCT= Social Cognitive Theory; MVPA= moderator to vigorous physical activity; EHR= electronic health record.

Figure 3.. Overview of the MyActivity Patient Portal Features.

Participants receive a weekly patient portal messages with access to graphs of their progress; each week covers a different topic targeting social cognitive theory constructs.