NCT06809933NARecruiting

Exercise and Movement to Enhance Resiliency in Cancer Patients

University of California, San Francisco

Start Date

3/24/2025

Completion Date

8/31/2031

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

OTHER

Digital Health Mobile App

OTHER

Virtual Support Group

OTHER

Health Coaching

OTHER

FitBit

OTHER

Handouts

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Conditions

Gynecologic Cancer

Locations

University of California, San Francisco

San Francisco, California 94143

United States