NCT06809933

Exercise and Movement to Enhance Resiliency in Cancer Patients

EMPOWER: Exercise and Movement to Promote Our Patients With (Gynecologic) Cancer to Enhance Resiliency

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecologic Cancer

Interventions

Type	Name	Description
OTHER	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
OTHER	Virtual Support Group	An institutional, virtual peer support group session will include a maximum of 5 participant per group
OTHER	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
OTHER	FitBit	FitBit is a health and activity tracking device placed around the wrist
OTHER	Handouts	A handout with exercise recommendations for those with cancer in accordance with national guidelines

Timeline

• Start date: 2025-03-24
• Primary completion: 2031-08-31
• Completion: 2031-08-31
• First posted: 2025-02-05
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States