Recruiting

Exercise & Movement

Sponsor:

UCLA

Code:

NCT06809933

Conditions

Gynecologic Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital Health Mobile App

Virtual Support Group

Health Coaching

FitBit

Handouts

Study Details

Brief summary:

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.

Conditions

Gynecologic Cancer

Study ID

NCT06809933

Start date

Mar 24, 2025

Status verified date

Jan, 2026

Completion date

Aug 31, 2031

Anticipated

Primary completion date

Aug 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 years or older.
2. Newly diagnosed with a gynecological cancer (including ovarian tubal or peritoneal, uterine, cervical, vaginal, vulvar, and/or gestational trophoblastic neoplasia) and currently undergoing treatment chemotherapy, surgery, etc.).
3. Able to understand study procedures and to comply with study procedures for the entire length of the study.
4. Ability to understand a written informed consent document, and the willingness to sign it.
5. Eastern Cooperative Oncology Group (ECOG) status < 4.
6. Willingness to participate and wear an activity tracker (FitBit).
7. Planning to start systemic treatment or currently receiving Cycle 1 of systemic treatment.

Exclusion Criteria:

1. Medically ineligible or contraindications to exercise as determined by their oncologist; or contradiction to any other study-related procedure or assessment.
2. Cognitive or visual impairments that would limit participant's ability to utilize and interact with the DHT platform. Note: If a visually impaired participant has a caregiver who can help them use the DHT platform, the participant will not be excluded.
3. Existing performance of excessive physical activity (>210 minutes per week of moderate to vigorous intensity exercise at baseline).
4. Existing enrollment in an exercise program or physical therapy program.
5. Inability to speak and read English.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Stage 1: EMPOWER Feasibility Cohort

The first 20 participants enrolled with receive the EMPOWER intervention which consists of the "Move" mobile application that synchronizes with a FitBit 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.

experimental: Stage 2: EMPOWER

Participants randomized to the EMPOWER intervention will receive the "Move" mobile application that synchronizes with a FitBit 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.

active comparator: Stage 2: Enhanced usual care (EUS)

Participants randomized to the EUS group will receive a similar kit that includes a FitBit (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 the FitBit to be linked to a study email that provides a summary of weekly activity to track activity throughout the study.

Interventions

Digital Health Mobile App

A digital health technology (DHT) called "Move" by Sword Health, which utilizes a mobile app displaying tailored and recommended exercise options, wearable technology (Move wearable or equivalent), and a web-based platform monitored by a physical therapist who will provide individual support

Virtual Support Group

An institutional, virtual peer support group session will include a maximum of 5 participant per group

Health Coaching

The facilitated group and discussions sessions will be led by a University of California, San Francisco (UCSF) certified health coach (CHC), following a pre-specified agenda and provided virtually

FitBit

FitBit is a health and activity tracking device placed around the wrist

Handouts

A handout with exercise recommendations for those with cancer in accordance with national guidelines

Primary outcome measure

  • Recruitment Rate (Stage 1) [ Time Frame: Up to 20 days ]
  • Recruitment Rate (Stage 2) [ Time Frame: Up to 20 days ]
  • Enrollment Rate (Stage 1) [ Time Frame: Up to 20 days ]
  • Enrollment Rate (Stage 2) [ Time Frame: Up to 20 days ]
  • Percentage of participants recommending the EMPOWER intervention (Stage 1 & 2, EMPOWER Participants only) [ Time Frame: 1 day ]
  • Percentage of participants adherence to the intervention (Stage 2, EMPOWER Participants only) [ Time Frame: Up to 16 weeks ]

Central Contacts and Locations

Central contacts

Nathalie Halley

877-827-3222EMPOWER@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Nathalie Halley

EMPOWER@ucsf.edu

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Stephanie Cham, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • Physical Activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-01-26.