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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

NCT ID: NCT07302230

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-05-31

Brief Summary

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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

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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.

Conditions

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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

Keywords

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Urinary Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Study statistician will be blinded to group assignment

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Given instruction to continue physical activity as usual

Internet-Based Intervention

Intervention Type OTHER

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

Health Telemonitoring

Intervention Type OTHER

Given a FitBit® to wear continuously

Educational Intervention

Intervention Type OTHER

Given NCCN Survivorship for Healthy Living Guidelines pamphlet

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

Ancillary studies

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Internet-Based Intervention

Intervention Type OTHER

Given access to the ExerciseRx app

Exercise Intervention

Intervention Type OTHER

Complete home exercise sessions

Health Telemonitoring

Intervention Type OTHER

Given a FitBit® to wear continuously

Educational Intervention

Intervention Type OTHER

Given NCCN Survivorship for Healthy Living Guidelines pamphlet

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

Ancillary studies

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Interventions

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Internet-Based Intervention

Given access to the ExerciseRx app

Intervention Type OTHER

Best Practice

Given instruction to continue physical activity as usual

Intervention Type OTHER

Internet-Based Intervention

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

Intervention Type OTHER

Exercise Intervention

Complete home exercise sessions

Intervention Type OTHER

Health Telemonitoring

Given a FitBit® to wear continuously

Intervention Type OTHER

Educational Intervention

Given NCCN Survivorship for Healthy Living Guidelines pamphlet

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Andy Hill CARE Fund

UNKNOWN

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Psutka, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Central Contacts

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Sarah Psutka, MD, MSc

Role: CONTACT

Phone: 206-210-4040

Email: [email protected]

Facility Contacts

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Sarah Psutka, MD, MSc

Role: primary

Other Identifiers

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NCI-2025-08850

Identifier Type: REGISTRY

Identifier Source: secondary_id

21052

Identifier Type: OTHER

Identifier Source: secondary_id

RG1125987

Identifier Type: -

Identifier Source: org_study_id