This clinical trial studies how well an exercise program and support groups (EMPOWER) work to improve the health of patients receiving treatment for gynecologic cancers. Research shows exercise during treatment for cancer has been shown to have consistent evidence for improving cardiorespiratory fitness, muscle strength, and patient-centered outcomes, such as fatigue, quality of life, sleep, physical function, and anxiety/depression, and to mitigate cancer treatment side effects. EMPOWER is a form of digital health technology (DHT) that utilizes a mobile application (app) that synchronizes with a wearable device that tracks heart rate, step count, and motion, as well as an online peer support network with individual and small group sessions. Participating in the EMPOWER program may work better at improving the health of patients receiving treatment for gynecologic cancers.
Additional locations may be listed on ClinicalTrials.gov for NCT06809933.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Contact: Stephanie Cham
Phone: 415-353-9600
PRIMARY OBJECTIVES:
I. To assess the feasibility of recruitment of the EMPOWER intervention. (Stage I)
II. To assess the acceptability of the EMPOWER intervention. (Stage I)
III. To assess the feasibility of recruitment of the study when randomized. (Stage II)
IV. To assess the acceptability of a randomized study (in both groups). (Stage II)
SECONDARY OBJECTIVES:
I. To evaluate retention and adherence of the interventions. (Stage I and II)
II. To evaluate the components of acceptability and adherence of the interventions. (Stage I and II)
III. To evaluate changes in objective physical activity measures as a single arm pilot study (stage 1) and compared to enhanced usual care (EUS) (stage 2) of the EMPOWER intervention. (Stage I and II)
IV. To evaluate changes in improving patient reported quality of life measures as a single arm pilot study (stage 1) and compared to EUS (stage 2) of the EMPOWER intervention. (Stage I and II)
EXPLORATORY OBJECTIVES:
I. To evaluate the magnitude of change in the burden of unplanned healthcare utilization the EMPOWER intervention. (Stage I and II)
II. To evaluate change in postoperative morbidity/mortality of the EMPOWER intervention. (Stage I and II)
III. To evaluate distribution of change in chemotherapy adverse effects of the EMPOWER intervention. (Stage I and II)
IV. To perform a post-intervention survey and qualitative interviews to optimize the intervention for future iterations. (Stage I and II)
V. To evaluate the feasibility of collection of long-term outcomes. (Stage I and II)
OUTLINE:
STAGE I: Patients receive access to the Move mobile app and wear a wrist-based activity tracker and complete exercise sessions over 5-30 minutes with a physical therapist for 16 weeks on study. Patients also participate in group discussion sessions via Zoom every two weeks followed by individual and groups sessions with either a physical therapist or certified health coach on the mobile app for 8 sessions for a total of 16 weeks on study.
STAGE II: Patients are randomized to 1 of 2 arms.
ARM I: Patients wear an activity tracker and complete exercise sessions over 5-30 minutes via the Move mobile app with a physical therapist for 16 weeks on study. Patients also participate in group discussion sessions via Zoom every two weeks followed by individual and groups sessions with either a physical therapist or certified health coach on the mobile app for 8 sessions for a total of 16 weeks on study.
ARM II: Patients receive usual care and wear an activity tracker and receive educational handouts that details recommended national guidelines on exercise during cancer treatment for 16 weeks on study. Patients also download Fitabase for monitoring FitBit data.
After completion of study intervention, patients are followed up at 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorStephanie Cham
