Exercise and Movement to Enhance Resiliency in Cancer Patients (EMPOWER)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Gynecologic Cancer

Treatments: Other: Health Coaching; Other: Handouts; Other: FitBit; Other: Digital Health Mobile App; Other: Virtual Support Group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06809933

NCI-2025-00773 (Registry Identifier)

244013

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

Stage 1 (single-arm pilot of intervention)

I. To assess the feasibility of recruitment of the EMPOWER intervention.

II. To assess the acceptability of the Exercise and Movement to Enhance Resiliency in Cancer Patients (EMPOWER) intervention.

Stage 2 (pilot randomized study comparing EMPOWER to enhanced usual care (EUS).

I. To assess the feasibility of recruitment of the study when randomized.

II. To assess the acceptability of a randomized study (in both groups)

SECONDARY OBJECTIVES:

Stage 1 and 2

I. To evaluate retention and adherence of the interventions.

II. To evaluate the components of acceptability and adherence of the interventions.

III. To evaluate changes in objective physical activity measures as a single arm pilot study (stage 1) and compared to EUS (stage 2) of the EMPOWER intervention.

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.

OUTLINE:

Participants will be enrolled in 2 stages.

Stage 1 is a single-arm pilot study testing the EMPOWER intervention to gather feedback for refinement and optimization of the program to implement in Stage 2.

Stage 2 is a pilot, randomized trial where participants will be assigned in a 1 to 1 ratio to either the EMPOWER program or EUS. All participants will be stratified by treatment type (neoadjuvant versus adjuvant therapy).

Participants will be enrolled in these interventions for a total of 16 weeks and receive a 3-month follow-up.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Stage 1: EMPOWER Feasibility Cohort

Experimental group

Description:

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.

Treatment:

Other: Virtual Support Group

Other: Digital Health Mobile App

Other: Health Coaching

Stage 2: EMPOWER

Experimental group

Description:

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.

Treatment:

Other: Virtual Support Group

Other: Digital Health Mobile App

Other: Health Coaching

Stage 2: Enhanced usual care (EUS)

Active Comparator group

Description:

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.

Treatment:

Other: FitBit

Other: Handouts