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 (EMPOWER)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stage 0a Bladder Cancer AJCC v8; Stage 0is Bladder Cancer AJCC v8; Stage I Bladder Cancer AJCC v8; Localized Non-Muscle Invasive Bladder Urothelial Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Interview; Other: Electronic Health Record Review; Other: Internet-Based Intervention; Other: Best Practice; Other: Internet-Based Intervention; Other: Health Telemonitoring; Other: Educational Intervention; Other: Exercise Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Psutka, MD, MSc; Phone Number: 206-210-4040; Email: spsutka@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Sarah Psutka, MD, MSc; Phone Number: 206-210-4040; Email: spsutka@uw.edu
      • Principal Investigator: Sarah Psutka, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Internet-Based Intervention; Given access to the ExerciseRx app; Other: Best Practice; Given instruction to continue physical activity as usual; Other Names: standard of care; Other: Internet-Based Intervention; Given access to the ExerciseRx app locked to the baseline home screen; Other: Health Telemonitoring; Given a FitBit® to wear continuously; Other: Educational Intervention; Given NCCN Survivorship for Healthy Living Guidelines pamphlet
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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Internet-Based Intervention; Given access to the ExerciseRx app; Other: Internet-Based Intervention; Given access to the ExerciseRx app locked to the baseline home screen; Other: Health Telemonitoring; Given a FitBit® to wear continuously; Other: Educational Intervention; Given NCCN Survivorship for Healthy Living Guidelines pamphlet; Other: Exercise Intervention; Complete home exercise sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active time/24 hours (minutes) per week on study	A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to Health Education Group (HEG). Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Up to 12 weeks
Change in mean daily step count	A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Change in functional mobility	Assessed by the Short Physical Performance Battery. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Change in frailty	Assessed by the Cancer and Aging Research Group - Geriatric Assessment. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Change in health-related quality of life	Will include physical function, role function, emotional function, cognitive function, and social function. Assessed by the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (Core 30) (EORTC-QLQ-C30) and EORTC Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer Module (24 items) (EORTC-QLQ-NMIBC24). A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Change in fatigue	Will be assessed using the Insomnia and Symptom Scale of the EORTC-QLQ-C30. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Change in pain	Will be assessed using the Symptom Scale of the EORTC-QLQ-C30. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Change in anxiety/depression	Will be assessed using the Hospital Anxiety and Depression Scale (HADS)-Anxiety and HADS-Depression (14 items). A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Change in distress	Will be assessed using the Perceived Stress Scale. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Change in resiliency	Will be assessed using the Brief Resiliency Scale. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Change in treatment burden	Will be assessed using the Treatment Burden Questionnaire (engagement in healthcare). Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Incidence of patient-reported musculoskeletal adverse events	A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Incidence of treatment-associated toxicity	Will be assessed using the EORTC-NMIBC 24. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Incidence of patient-reported outcomes	Will be assessed using the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events version 5.0 and chart review. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Up to 4 weeks post intervention
Barriers and facilitators to exercise	Will be assessed using the weekly barriers and facilitators to exercise survey. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention
Change in Lifespace	Will be assessed using the Lifespace questionnaire. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time.	Baseline up to 4 weeks post intervention

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Andy Hill CARE Fund
• Investigators: Principal Investigator: Sarah Psutka, MD, MSc, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Urinary Bladder
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Guidelines as Topic; Quality Assurance, Health Care; Interviews as Topic; Standard of Care; Early Intervention, Educational; Practice Guidelines as Topic
• Other Study ID Numbers: RG1125987; 21052 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2025-08850 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No