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The EMPOWER Trial: Evaluating a Home-Based Physical Activity Program (PAP) With the ExerciseRx™ Digital Platform vs. Health Education Group (HEG) in People With Non-Muscle Invasive Bladder Cancer

NCT ID: NCT07302230Sponsor: University of WashingtonLast updated: 2026-03-13

Summary

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.

Detailed description

OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (Health Education Group, HEG): Patients receive recommendations from their physicians and an educational pamphlet describing physical activity goals in line with National Comprehensive Cancer Network (NCCN) Survivorship for Healthy Living Guidelines. They receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen. GROUP II (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 personalized daily step count goals that gradually increase over the study period. Patients also receive a FitBit® to wear continuously throughout the study, are given access to features of the ExerciseRx app (step count goals, home exercise videos), and receive an educational pamphlet as in Group I. After completion of the study intervention, patients are followed up at 4 weeks.

Arms & interventions

  • OtherInternet-Based Intervention

    Given access to the ExerciseRx app

  • OtherBest Practice

    Given instruction to continue physical activity as usual

  • OtherInternet-Based Intervention

    Given access to the ExerciseRx app locked to the baseline home screen

  • OtherExercise Intervention

    Complete home exercise sessions

  • OtherHealth Telemonitoring

    Given a FitBit® to wear continuously

  • OtherEducational Intervention

    Given NCCN Survivorship for Healthy Living Guidelines pamphlet

  • OtherQuestionnaire Administration

    Ancillary studies

  • OtherInterview

    Ancillary studies

  • OtherElectronic Health Record Review

    Ancillary studies

Outcome measures

Primary

  • Change in mean daily step count

    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.

    Time frame: Baseline (1 week prior to trial initiation) and timepoint 2 (12 weeks)

  • Qualitative experience

    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.

    Time frame: Week 16

Secondary

  • Active time/24 hours (minutes) per week on study

    Time frame: Up to 12 weeks

  • Change in mean daily step count

    Time frame: Baseline up to 4 weeks post intervention

  • Change in functional mobility

    Time frame: Baseline up to 4 weeks post intervention

  • Change in frailty

    Time frame: Baseline up to 4 weeks post intervention

  • Change in health-related quality of life

    Time frame: Baseline up to 4 weeks post intervention

  • Change in fatigue

    Time frame: Baseline up to 4 weeks post intervention

  • Change in pain

    Time frame: Baseline up to 4 weeks post intervention

  • Change in anxiety/depression

    Time frame: Baseline up to 4 weeks post intervention

  • Change in distress

    Time frame: Baseline up to 4 weeks post intervention

  • Change in resiliency

    Time frame: Baseline up to 4 weeks post intervention

  • Change in treatment burden

    Time frame: Baseline up to 4 weeks post intervention

  • Incidence of patient-reported musculoskeletal adverse events

    Time frame: Baseline up to 4 weeks post intervention

  • Incidence of treatment-associated toxicity

    Time frame: Baseline up to 4 weeks post intervention

  • Incidence of patient-reported outcomes

    Time frame: Up to 4 weeks post intervention

  • Barriers and facilitators to exercise

    Time frame: Baseline up to 4 weeks post intervention

  • Change in Lifespace

    Time frame: Baseline up to 4 weeks post intervention

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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 Criteria: * 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

Study locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

Recruiting
Sarah Psutka, MD, MSc · Contact
206-210-4040spsutka@uw.edu
Sarah Psutka, MD, MSc · Principal Investigator