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.
Original language | English (US) |
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Article number | 107187 |
Journal | Contemporary Clinical Trials |
Volume | 130 |
DOIs | |
State | Published - Jul 2023 |
Funding
This work was supported by the National Cancer Institute R37CA25877 . Development of the project was supported by National Cancer Institute K07CA196840 and K07CA178870 . The project described was supported by the Clinical and Translational Science Award (CTSA) program, through the NIH National Center for Advancing Translational Sciences (NCATS), grant UL1TR002373 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. This work was supported by the National Cancer Institute R37CA25877. Development of the project was supported by National Cancer Institute K07CA196840 and K07CA178870. The project described was supported by the Clinical and Translational Science Award (CTSA) program, through the NIH National Center for Advancing Translational Sciences (NCATS), grant UL1TR002373. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Keywords
- Adaptive intervention
- Breast cancer
- Digital health
- Endometrial cancer
- Physical activity
- cancer survivorship
ASJC Scopus subject areas
- Pharmacology (medical)