Exercise and Movement to Enhance Resiliency in Cancer Patients

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06809933
Status
Recruiting
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Conditions

  • Gynecologic Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Digital Health Mobile App — OTHER
    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 — OTHER
    An institutional, virtual peer support group session will include a maximum of 5 participant per group
  • Health Coaching — OTHER
    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 — OTHER
    FitBit is a health and activity tracking device placed around the wrist
  • Handouts — OTHER
    A handout with exercise recommendations for those with cancer in accordance with national guidelines

Study Details

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.

Key Dates

Start date
Mar 24, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Recruitment Rate (Stage 1) [ Time Frame: Up to 20 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Nathalie Halley
[email protected]
[email protected]
877-827-3222
Stephanie Cham, MD (PRINCIPAL_INVESTIGATOR)

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