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Home-Based Physical Activity Program for Non-Muscle Invasive Bladder Cancer

This study, called EMPOWER, is testing if a home-based physical activity program delivered through a digital app (ExerciseRx app) can help people with non-muscle invasive bladder cancer (cancer that hasn't spread to the bladder muscle) become more physically active. You would either receive health education and a Fitbit, or use the ExerciseRx app with personalized exercise sessions and a Fitbit. The study aims to see if using the app increases your daily step count over 12 weeks and to understand your experience with the program. To join, you need to be an adult (18 or older) with this type of bladder cancer, not currently active enough, and have a smartphone or tablet. The study plans to enroll 100 participants, but its current status is unclear.

Study design
This interventional study randomizes 100 participants into two groups to compare a digital app-based exercise program with a health education group.
What's involved
Participants will wear a Fitbit continuously throughout the study. If in the exercise group, you will complete home exercise sessions via the ExerciseRx app for 20-30 minutes, four times a week for 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
After the 12-week intervention, patients are followed up at 4 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07302230

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

Recruiting
NAAges 18+InterventionalSupportive care
University of Washington
~100 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Internet-Based InterventionBest PracticeExercise InterventionHealth TelemonitoringEducational InterventionQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in mean daily step count
Measured over Baseline (1 week prior to trial initiation) and timepoint 2 (12 weeks)
+1 more outcome measured

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

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Bladder Carcinoma

NCT07302230

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washingtonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sarah Psutka, MD, MSc · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Sarah Psutka, MD, MSc
[email protected]
206-210-4040
Email the study team

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Eligibility criteria

Inclusion

Adults (age \>= 18 years)
Prior diagnosis of non-muscle invasive bladder cancer (NMIBC), currently on surveillance or receiving maintenance intravesical therapy (including intravesical chemotherapy, immunotherapy)
Classified as insufficiently active on the Physical Activity as a Vital Sign (PAVS) assessment
Has an Android or Apple Smartphone/Tablet
Ambulatory
English-speaking
Willing and able to participate in study activities and sign the informed consent form

Exclusion

Severe cognitive or memory impairment/dementia precluding ability to follow instructions or participate in survey assessments
Inability to read or understand English
Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria to run the ExerciseRx app
Not receiving treatment at University of Washington (UW)
Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
Inability/Unwillingness to participate in a personalized exercise program
Current diagnosis with muscle-invasive or metastatic bladder cancer
Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria for using the ExerciseRx app
Participation in a clinical trial that does not permit enrollment in the EMPOWER trial

What this trial measures

  • Change in mean daily step countBaseline (1 week prior to trial initiation) and timepoint 2 (12 weeks)

    Average daily step count (per 24-hour day) will be assessed by the Fitbit tracker. Summary statistics (mean and standard deviations; counts and percentages) will be used to describe and compare baseline characteristics between the two treatment arms. Will use a linear mixed effects model with average daily step count as the outcome, with fixed effects for time (T1, T2, and T3), treatment assignment, and the week-treatment interaction, and a random intercept for each participant. A significant interaction between T2 and treatment assignment will indicate the change in step count from baseline to T2 differs between the two treatment arms and will be used to evaluate the co-primary outcomes of step-count improvement at the end of treatment using a two-sided significance level of 0.05. The minimum amount of time that participants need to have worn the Fitbit for their step data to be valid for use in analysis is one week (7 days) post baseline period.

  • Qualitative experienceWeek 16

    Will be assessed by Zoom interviews (usability interview) with a subset of volunteer participants from the physical activity program (PAP) arm. Will analyze the semi-structured interview data using a process of reflexive thematic analysis, drawing on our reflexivity as designers, health informatics researchers, and clinical researchers to interpret data and construct themes using affinity analysis to identify ways in which ExerciseRx can be improved to meet the needs of patients with bladder cancer. Similarly, will apply the Discover Design Built Test framework from the University of Washington ALACRITY Center to adapt the ExerciseRx provider dashboard for healthcare providers caring for patients with bladder cancer.