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

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.

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

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

Sponsors & Collaborators

• Andy Hill CARE Fund

  collaborator UNKNOWN

• University of Washington

  lead OTHER

Principal Investigators

• Sarah Psutka, MD, MSc · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-11

Primary Completion

2027-02-26

Completion

2027-05-31

Countries

• United States

Study Locations