Home-Based Physical Activity Program With Digital App Versus Health Education Group for Improving Physical Activity Among Patients With Non-muscle Invasive Bladder Cancer, The EMPOWER Trial

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07302230
Status
Recruiting
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Conditions

  • Localized Non-Muscle Invasive Bladder Urothelial Carcinoma
  • Stage 0a Bladder Cancer AJCC v8
  • Stage 0is Bladder Cancer AJCC v8
  • Stage I Bladder Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Internet-Based Intervention — OTHER
    Given access to the ExerciseRx app
  • Best Practice — OTHER
    Given instruction to continue physical activity as usual
  • Internet-Based Intervention — OTHER
    Given access to the ExerciseRx app locked to the baseline home screen
  • Exercise Intervention — OTHER
    Complete home exercise sessions
  • Health Telemonitoring — OTHER
    Given a FitBit® to wear continuously
  • Educational Intervention — OTHER
    Given NCCN Survivorship for Healthy Living Guidelines pamphlet
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Interview — OTHER
    Ancillary studies
  • Electronic Health Record Review — OTHER
    Ancillary studies

Study Details

This clinical trial compares how well a home-based personalized physical activity program (PAP) that is delivered by a digital application (app) (the ExerciseRx app) works compared to health education in improving physical activity for patients with bladder cancer that has not reached the muscle wall of the bladder (non-muscle invasive). For people who are not physically active, previous studies have shown that increasing step counts can reduce incidence of death, reduce frailty, and reduce healthcare costs. The ExerciseRx app tracks adherence to home exercise, adapts step count goals based on the patient's progress, and provides encouraging feedback and motivation from the healthcare team. Additional features include activity summaries, progress towards current goal, nudges, helpful facts about the benefits of activity, and ideas for how to incorporate daily movement. A home-based PAP using the ExerciseRx app may work better in increasing physical activity among patients with non-muscle invasive bladder cancer compared to a health education only group.

Key Dates

Start date
Mar 11, 2026
Status verified
Dec 2025
Primary completion
Feb 26, 2027
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Group I: Health Education Group (HEG)
    Patients receive recommendations from their physicians to continue their usual physical activity as tolerated, receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen, and receive an educational pamphlet describing physical activity goals in line with NCCN Survivorship for Healthy Living Guidelines.
  • Experimental: Group II: Physical Activity Program (PAP) intervention
    Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive daily step count goals. Patients also receive a FitBit® to wear continuously throughout the study, and are given access to view their step counts via the ExerciseRx app, and receive an educational pamphlet as in Group I.

Primary Outcome Measure

Change in mean daily step count [ Time Frame: Baseline (1 week prior to trial initiation) and timepoint 2 (12 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Sarah Psutka, MD, MSc
[email protected]
206-210-4040
Sarah Psutka, MD, MSc (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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