Exercise and Movement to Enhance Resiliency in Cancer Patients
EMPOWER
EMPOWER: Exercise and Movement to Promote Our Patients With (Gynecologic) Cancer to Enhance Resiliency
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2025
CompletedFirst Posted
Study publicly available on registry
February 5, 2025
CompletedStudy Start
First participant enrolled
March 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2031
January 26, 2026
January 1, 2026
6.4 years
January 30, 2025
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Recruitment Rate (Stage 1)
Feasibility of the intervention is defined as \>= 30% recruitment rate for participants in Stage 1.
Up to 20 days
Recruitment Rate (Stage 2)
Feasibility of the intervention is defined as \>= 30% recruitment rate for participants in Stage 2.
Up to 20 days
Enrollment Rate (Stage 1)
Feasibility of the intervention is defined as \> 30% enrollment rate for participants in Stage 1.
Up to 20 days
Enrollment Rate (Stage 2)
Feasibility of the intervention is defined as \> 30% enrollment rate for participants in Stage 2.
Up to 20 days
Percentage of participants recommending the EMPOWER intervention (Stage 1 & 2, EMPOWER Participants only)
Acceptability of the intervention will be measured by a physician designed questionnaire assessing the acceptability of the EMPOWER intervention. The questionnaire is an 8-item measure of which assesses participants perceived acceptability of the EMPOWER program. Each item response falls on a scale of 1 (Strongly disagree) to 5 (Strongly agree). The percentage of participants with a response of either agree or strongly agree will be reported.
1 day
Percentage of participants adherence to the intervention (Stage 2, EMPOWER Participants only)
Adherence to the intervention will be measured for each participant, from week 1 to study completion per data collected by wearable device and by CHC collection. The percentage of participants will be reported
Up to 16 weeks
Secondary Outcomes (13)
Retention Rate
Up to 16 weeks
Percentage of participants who completed prescribed exercises
Up to 16 weeks
Percentage of participants who utilized the mobile application
Up to 16 weeks
Percent attendance of the online meetings
Up to 16 weeks
Mean changes in average step count over time
Up to 16 weeks
- +8 more secondary outcomes
Study Arms (3)
Stage 1: EMPOWER Feasibility Cohort
EXPERIMENTALThe 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.
Stage 2: EMPOWER
EXPERIMENTALParticipants 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.
Stage 2: Enhanced usual care (EUS)
ACTIVE COMPARATORParticipants 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
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
An institutional, virtual peer support group session will include a maximum of 5 participant per group
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 is a health and activity tracking device placed around the wrist
A handout with exercise recommendations for those with cancer in accordance with national guidelines
Eligibility Criteria
You may qualify if:
- Age 18 years or older.
- 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.).
- Able to understand study procedures and to comply with study procedures for the entire length of the study.
- Ability to understand a written informed consent document, and the willingness to sign it.
- Eastern Cooperative Oncology Group (ECOG) status \< 4.
- Willingness to participate and wear an activity tracker (FitBit).
- Planning to start systemic treatment or currently receiving Cycle 1 of systemic treatment.
You may not qualify if:
- Medically ineligible or contraindications to exercise as determined by their oncologist; or contradiction to any other study-related procedure or assessment.
- 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.
- Existing performance of excessive physical activity (\>210 minutes per week of moderate to vigorous intensity exercise at baseline).
- Existing enrollment in an exercise program or physical therapy program.
- Inability to speak and read English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Sword Health, SAcollaborator
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Cham, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2025
First Posted
February 5, 2025
Study Start
March 24, 2025
Primary Completion (Estimated)
August 31, 2031
Study Completion (Estimated)
August 31, 2031
Last Updated
January 26, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share