Exercise and Movement to Enhance Resiliency in Cancer Patients
NCT ID: NCT06809933
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-03-24
2031-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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
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.
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
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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Sword Health, SA
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Stephanie Cham, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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NCI-2025-00773
Identifier Type: REGISTRY
Identifier Source: secondary_id
244013
Identifier Type: -
Identifier Source: org_study_id
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