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

NCT07302230 | Recruiting

• 3 other identifiers: RG1125987NCI-2025-0885021052
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

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

Keywords

Urinary Bladder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

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

  Up to 12 weeks

• Change in mean daily step count

  Baseline up to 4 weeks post intervention

• Change in functional mobility

  Baseline up to 4 weeks post intervention

• Change in frailty

  Baseline up to 4 weeks post intervention

• Change in health-related quality of life

  Baseline up to 4 weeks post intervention

Study Arms (2)

Group I: Health Education Group (HEG)

ACTIVE COMPARATOR

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: Best Practice; Other: Internet-Based Intervention; Other: Health Telemonitoring; Other: Educational Intervention; Other: Questionnaire Administration; Other: Interview; Other: Electronic Health Record Review

Group II: Physical Activity Program (PAP) intervention

EXPERIMENTAL

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: Internet-Based Intervention; Other: Exercise Intervention; Other: Health Telemonitoring; Other: Educational Intervention; Other: Questionnaire Administration; Other: Interview; Other: Electronic Health Record Review

Interventions

Internet-Based Intervention OTHER

Given access to the ExerciseRx app

Group II: Physical Activity Program (PAP) intervention

Best Practice OTHER

Given instruction to continue physical activity as usual

Also known as: standard of care

Group I: Health Education Group (HEG)

Exercise Intervention OTHER

Complete home exercise sessions

Group II: Physical Activity Program (PAP) intervention

Health Telemonitoring OTHER

Given a FitBit® to wear continuously

Group I: Health Education Group (HEG); Group II: Physical Activity Program (PAP) intervention

Educational Intervention OTHER

Given NCCN Survivorship for Healthy Living Guidelines pamphlet

Group I: Health Education Group (HEG); Group II: Physical Activity Program (PAP) intervention

Questionnaire Administration OTHER

Ancillary studies

Group I: Health Education Group (HEG); Group II: Physical Activity Program (PAP) intervention

Interview OTHER

Ancillary studies

Group I: Health Education Group (HEG); Group II: Physical Activity Program (PAP) intervention

Electronic Health Record Review OTHER

Ancillary studies

Group I: Health Education Group (HEG); Group II: Physical Activity Program (PAP) intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Andy Hill CARE Fund: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Interviews as Topic

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Sarah Psutka, MD, MSc

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Psutka, MD, MSc

CONTACT

206-210-4040; spsutka@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study statistician will be blinded to group assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: March 11, 2026
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)