Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07302230

The EMPOWER Trial: Home-Based Physical Activity Program Using the ExerciseRx Digital Platform Versus Health Education for Patients with Non-Muscle Invasive Bladder Cancer

Led by University of Washington · Updated on 2026-03-13

100

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

A

Andy Hill CARE Fund

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how well a home-based personalized physical activity program (PAP) delivered through the ExerciseRx digital app improves physical activity in patients with non-muscle invasive bladder cancer. This type of bladder cancer has not spread into the muscle wall. Increasing physical activity has been linked to benefits such as lower death rates, less frailty, and reduced healthcare costs. The study compares the ExerciseRx app program to standard health education. Participants are randomly assigned to one of two groups. One group receives usual care recommendations, a FitBit to wear continuously, and an educational pamphlet with physical activity goals, with the ExerciseRx app locked on their device. The other group follows home exercise sessions via the ExerciseRx app for 20-30 minutes, four times a week over 12 weeks, with personalized daily step goals that increase over time. They also receive a FitBit, the educational pamphlet, and full access to the app's features. Throughout the study, participants wear a FitBit to track activity and complete assessments of step counts, functional mobility, frailty, quality of life, fatigue, pain, mental health, and treatment burden. After the 12-week intervention, participants are followed up for an additional 4 weeks to evaluate ongoing effects and their experience. The study measures changes in daily steps from baseline to 12 weeks and collects qualitative feedback at week 16 to understand participant experience.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Prior diagnosis of non-muscle invasive bladder cancer (NMIBC), currently on surveillance or receiving maintenance intravesical therapy
  • Classified as insufficiently active on the Physical Activity as a Vital Sign (PAVS) assessment
  • Has access to an Android or Apple smartphone or tablet
  • Able to walk (ambulatory)
  • English-speaking
  • Willing and able to participate in study activities and sign informed consent
Not Eligible

You will not qualify if you...

  • Severe cognitive or memory impairment or dementia preventing participation
  • Unable to read or understand English
  • Lack of access to or inability to use an Android or iOS device meeting app requirements
  • Not receiving treatment at University of Washington
  • Orthopedic, neurologic, or other conditions preventing safe walking or study adherence
  • Unwillingness or inability to participate in a personalized exercise program
  • Current diagnosis of muscle-invasive or metastatic bladder cancer
  • Uncontrolled or concurrent illnesses such as active infections, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
  • Participation in another clinical trial that disallows enrollment in this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants are randomized to either a Health Education Group receiving physical activity recommendations and an educational pamphlet with a FitBit® and locked ExerciseRx app, or a Physical Activity Program intervention completing home exercise sessions 4 times per week for 12 weeks with personalized step goals, FitBit®, and full access to the ExerciseRx app.

Weekly visits or check-ins during the 12-week intervention period

Follow-up

Duration - 4 weeks

Participants are followed up to assess outcomes such as physical activity, functional mobility, quality of life, and other health-related measures for 4 weeks after completing the intervention.

1 visit (in-person) approximately 4 weeks after intervention completion

Trial Site Locations

Total: 1 location

1

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

S

Sarah Psutka, MD, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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