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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07302230.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Sarah P Psutka
Phone: 206-210-4040
PRIMARY OBJECTIVES:
I. To understand the primary barriers and facilitators to activity in older cancer survivors.
II. To refine an existing digital health solution (ExerciseRx app) to successfully deliver personalized step count and home-based exercise recommendations in a manner acceptable to this patient population.
III. To evaluate the efficacy of a 12-week personalized step count and exercise recommendation intervention delivered via ExerciseRx app in a phase II randomized controlled trial (RCT).
SECONDARY OBJECTIVE:
I. To measure the impact of the PAP intervention on secondary objectives after 12-weeks of use, and at four weeks after intervention completion.
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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorSarah P Psutka
