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
University of Washington
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.
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 pe…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- OtherInternet-Based Intervention
Given access to the ExerciseRx app
- OtherBest Practice
Given instruction to continue physical activity as usual
- OtherInternet-Based Intervention
Given access to the ExerciseRx app locked to the baseline home screen
- OtherExercise Intervention
Complete home exercise sessions
- OtherHealth Telemonitoring
Given a FitBit® to wear continuously
- OtherEducational Intervention
Given NCCN Survivorship for Healthy Living Guidelines pamphlet
- Other
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington