Recruiting

ExerciseRx App

Sponsor:

University of Washington

Code:

NCT07302230

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+

Healthy Volunteers: Not accepted

Interventions

Internet-Based Intervention

Best Practice

Internet-Based Intervention

Exercise Intervention

Health Telemonitoring

Study Details

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

Study ID

NCT07302230

Start date

Mar 11, 2026

Status verified date

Jul, 2026

Completion date

Sep 27, 2027

Anticipated

Primary completion date

Aug 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Internet-Based Intervention

Given access to the ExerciseRx app

Best Practice

Given instruction to continue physical activity as usual

Internet-Based Intervention

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

Exercise Intervention

Complete home exercise sessions

Health Telemonitoring

Given a FitBit® to wear continuously

Educational Intervention

Given NCCN Survivorship for Healthy Living Guidelines pamphlet

Questionnaire Administration

Ancillary studies

Interview

Ancillary studies

Electronic Health Record Review

Ancillary studies

Primary outcome measure

  • Change in mean daily step count [ Time Frame: Baseline (1 week prior to trial initiation) and timepoint 2 (12 weeks) ]
  • Qualitative experience [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Sarah Psutka, MD, MSc

206-210-4040spsutka@uw.edu

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Sarah Psutka, MD, MSc

206-210-4040spsutka@uw.edu

Principal Investigator:

Sarah Psutka, MD, MSc

More Information

Sponsor

University of Washington

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Urinary Bladder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-07-06.