Exercise Program for Gynecologic Cancers
(EMPOWER Trial)

Recruiting in Palo Alto (17 mi)

Overseen byStephanie Cham, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a single-center, pilot, hybrid type 1 design implementation study to evaluate the feasibility and implementation of a personalized digital exercise program and a virtual support group to improve patient-centered outcomes in patients receiving treatment for gynecologic cancer receiving treatment at University of California, San Francisco.

Eligibility Criteria

This trial is for adults with newly diagnosed gynecologic cancer who are receiving treatment at the University of California, San Francisco. The study aims to include a diverse group of participants.

Inclusion Criteria

I understand and can follow the study's procedures.

Ability to understand a written informed consent document and willingness to sign it

I am starting or in my first cycle of systemic treatment.

+4 more

Exclusion Criteria

I can use the DHT platform on my own or with a caregiver's help.

Inability to speak and read English

Existing performance of excessive physical activity (>210 minutes per week of moderate to vigorous intensity exercise at baseline)

+2 more

Participant Groups

The effectiveness of a personalized digital exercise program and virtual support group is being tested. Participants will use a mobile app, wear an activity tracker, receive health coaching, and get educational handouts.

3Treatment groups

Experimental Treatment

Active Control

Group I: Stage 2: EMPOWERExperimental Treatment3 Interventions

Participants randomized to the EMPOWER intervention will receive the "Move" mobile application that synchronizes with a wearable device that tracks heart rate, step count, and motion and also receive UCSF-based, online peer support network with individual and small group sessions that occur every four weeks. Questionnaires will be given at baseline, week 9, the end of treatment, and at 3 months after completion of the interventions.

Group II: Stage 1: EMPOWER Feasibility CohortExperimental Treatment3 Interventions

The first 20 participants enrolled with receive the EMPOWER intervention which consists of the "Move" mobile application that synchronizes with a wearable device that tracks heart rate, step count, and motion and also receive UCSF-based, online peer support network with individual and small group sessions that occur every four weeks. Questionnaires will be given at baseline, week 9, the end of treatment, and at 3 months after completion of the interventions.

Group III: Stage 2: Enhanced usual care (EUS)Active Control2 Interventions

Participants randomized to the EUS group will receive a similar kit that includes a wearable activity tracker (equivalent features to what the intervention arm receives), and receive a handout that details recommended national guidelines on exercise during cancer treatment. Participants will be asked to allow their activity tracker to be linked to a study email that provides a summary of weekly activity to track activity throughout the study.