Home-based app-guided exercise program versus health education to boost activity in people with non-muscle invasive bladder cancer
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 project will see if a personalized, app-guided home exercise program helps people with non-muscle invasive bladder cancer increase their daily physical activity compared with standard health education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT07302230 on ClinicalTrials.gov |
What this trial studies
Participants with non-muscle invasive bladder cancer who are currently insufficiently active are randomized to one of two groups for 12 weeks. The intervention group uses the ExerciseRx app for personalized home exercise sessions and gradually increasing daily step goals, while the comparison group receives health education materials; all participants wear a Fitbit to track activity. The app adapts goals based on progress, provides feedback, and offers exercise videos and motivational nudges. Outcomes focus on changes in physical activity with a follow-up visit four weeks after the intervention ends.
Who should consider this trial
Good fit: Ideal candidates are adults with non-muscle invasive bladder cancer who are currently insufficiently active, ambulatory, English-speaking, own a compatible smartphone or tablet, and are receiving care at the University of Washington.
Not a fit: Patients who are already physically active, cannot safely ambulate, lack a compatible smart device, have significant cognitive impairment, or are not receiving care at the University of Washington are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could increase daily steps and reduce frailty and related healthcare use for patients with early-stage bladder cancer.
How similar studies have performed: Prior research in other populations shows that increasing step counts and using digital activity tools can reduce frailty and health risks, but personalized app-guided programs specifically in non-muscle invasive bladder cancer are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Psutka, MD, MSc — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Sarah Psutka, MD, MSc
- Email: spsutka@uw.edu
- Phone: 206-210-4040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.