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Brief Title: A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients Receiving Chemotherapy Before Radical Cystectomy, Get Moving Trial

The "Get Moving Trial": A Phase I/II RCT of Home-Based (P)Rehabilitation With ExerciseRx in Muscle-Invasive Bladder Cancer

INTRODUCTION

  • Org Study ID: RG1123479
  • Secondary ID: N/A
  • NCT ID: NCT06040762
  • Sponsor: University of Washington

BRIEF SUMMARY

Prehabilitation refers to the process of improving a patient's functional capabilities prior to a surgical procedure with the goal of decreasing post-surgical inactivity and physical decline. This clinical trial evaluates the utility of a personalized home-based prehabilitation exercise intervention for the improvement of physical function and surgical outcomes in patients receiving chemotherapy before routine radical cystectomy for localized (non-metastatic) muscle-invasive bladder cancer. The exercise intervention includes at-home exercise sessions focused on the improvement of core strength and balance as well as personalized step count goals, delivered to patients remotely via a smart-device-based application (ExerciseRx). Encouraging physical activity before surgery may improve physical function and surgical outcomes in patients who are scheduled to undergo surgery for their non-metastatic muscle-invasive bladder cancer.

DETAILED DESCRIPTION

OUTLINE: Patients are randomized to 1 of 2 arms and are followed from enrollment through neoadjuvant chemotherapy receipt, radical cystectomy, and for 90 days following surgery (total estimated time on study: ~7 months)

ARM A: Patients use the ExerciseRx application (app) to follow the (P)REHAB exercise program, which consists of four 20-30 minute home exercise sessions per week and personalized step count goal setting and tracking, while receiving standard of care (SOC) NAC prior to SOC radical cystectomy (RC), and for 90 days following surgery. Patients also wear a FitBit and use the FitBit app on study.

ARM B: Patients receive SOC educational materials and wear a FitBit and use the FitBit app while receiving SOC NAC prior to SOC RC.

After completion of study intervention, patients are followed up at 90 days following SOC RC.

  • Overall Status
    Recruiting
  • Start Date
    December 19, 2023
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Muscle Invasive Bladder Carcinoma
  • Stage II Bladder Cancer AJCC v8
  • Stage IIIA Bladder Cancer AJCC v8

ELIGIBILITY

Inclusion Criteria:
* 18 years of age or older

- * English-speaking

- * Diagnosis of American Urological Association (AUA) nonmetastatic muscle-invasive bladder cancer (MIBC) (e.g. American Joint Committee on Cancer [AJCC] pT2-4 N0-1 M0)

- * Patients who have been indicated for any neoadjuvant systemic therapy followed by RC in shared-decision-making with their primary urologist and medical oncologist

- * Have a smart device meeting study criteria or willing to use a study-supplied smart device

- * Willing and able to participate in trial activities

- * Able to understand and willing to sign written informed consent in English
Exclusion Criteria:
* Cognitive/mental impairment that will preclude ability to participate in routine exercise activities. Significant cognitive or memory impairment or baseline dementia that would preclude a patient's ability to follow instructions or reproduce exercises as characterized by scoring < 24 on the Minimental Status Examination - * Immobility, inability/unwillingness to perform personalized exercise program. Inability to perform exercises safely from seated or standing position at home or recent falls or high fall risk. Neurologic or orthopedic condition that restricts participation in unsupervised home exercises, such as prior stroke with neurologic impairment, weight bearing precautions, unwillingness to participate in exercises - * Participants who have nonmuscle-invasive bladder cancer, or radiographic evidence of metastatic disease involving other organs including brain metastases. Patients with predominant histology other than urothelial carcinoma of the bladder who would not otherwise be considered candidates for NAC or RC - * 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 - * Pregnant women are excluded from this study

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Sarah Psutka

Role: Principal Investigator

Affiliation: Fred Hutch/University of Washington Cancer Consortium

Overall Contact

Name: Get Moving Research Coordinator

Phone: 206-210-4040

Email: GetMoving@uw.edu

LOCATION

Facility Status Contact
Facility: Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109
United States 		Status: Recruiting Contact: Contact
Get Moving Research Coordinator
206-210-4040
GetMoving@uw.edu

Principal Investigator
Sarah Psutka

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