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Recruiting NCT07302230

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

No phase Interventional 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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internet-Based Intervention, Best Practice, Internet-Based Intervention, Exercise Intervention.
Who it may be relevant to
Registry 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. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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 personalized daily step count goals that gradually increase over the study period. Patients also receive a FitBit® to wear continuously throughout the study, are given access to features of the ExerciseRx app (step count goals, home exercise videos), and receive an educational pamphlet as in Group I.

After completion of the study intervention, patients are followed up at 4 weeks.

Interventions

  • Other Internet-Based Intervention
    Given access to the ExerciseRx app
  • Other Best Practice
    Given instruction to continue physical activity as usual
  • Other Internet-Based Intervention
    Given access to the ExerciseRx app locked to the baseline home screen
  • Other Exercise Intervention
    Complete home exercise sessions
  • Other Health Telemonitoring
    Given a FitBit® to wear continuously
  • Other Educational Intervention
    Given NCCN Survivorship for Healthy Living Guidelines pamphlet
  • Other Questionnaire Administration
    Ancillary studies
  • Other Interview
    Ancillary studies
  • Other Electronic Health Record Review
    Ancillary studies

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Active time/24 hours (minutes) per week on study [Time frame: Up to 12 weeks]
  • Change in mean daily step count [Time frame: Baseline up to 4 weeks post intervention]
  • Change in functional mobility [Time frame: Baseline up to 4 weeks post intervention]
  • Change in frailty [Time frame: Baseline up to 4 weeks post intervention]
  • Change in health-related quality of life [Time frame: Baseline up to 4 weeks post intervention]
  • Change in fatigue [Time frame: Baseline up to 4 weeks post intervention]
  • Change in pain [Time frame: Baseline up to 4 weeks post intervention]
  • Change in anxiety/depression [Time frame: Baseline up to 4 weeks post intervention]
  • Change in distress [Time frame: Baseline up to 4 weeks post intervention]
  • Change in resiliency [Time frame: Baseline up to 4 weeks post intervention]
  • Change in treatment burden [Time frame: Baseline up to 4 weeks post intervention]
  • Incidence of patient-reported musculoskeletal adverse events [Time frame: Baseline up to 4 weeks post intervention]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT07302230 · RG1125987 · NCI-2025-08850 · 21052

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗