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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 and Upper Tract Urothelial 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 with urothelial carcinoma undergoing definitive or consolidative surgery of the bladder (radical cystectomy) or upper tract (nephroureterectomy, ureterectomy) with or without preceding neoadjuvant/systemic therapy. 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 bladder or urothelial cancer.

DETAILED DESCRIPTION

OUTLINE: Patients are randomized to 1 of 2 arms and are followed from enrollment through surgery, and for 90 days following surgery (total estimated time on study: ~4-7 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 approximately 4-6 weeks prior to surgery and personalized step count goal setting and tracking, prior to standard of care (SOC) surgery, 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 prior to SOC surgery.

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

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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Trial recruitment

Primary Outcome 1 - Timeframe: At enrollment

Primary Outcome 2 - Measure: Trial retention

Primary Outcome 2 - Timeframe: Through study completion

Primary Outcome 3 - Measure: Change in physical function

Primary Outcome 3 - Timeframe: on average 4-7 months

Primary Outcome 4 - Measure: Change in physical function

Primary Outcome 4 - Timeframe: From enrollment (T1) to 1-4 months post enrollment (before surgery) (T2)

Primary Outcome 5 - Measure: Change in physical function

Primary Outcome 5 - Timeframe: From 1-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)

CONDITION

  • Bladder Cancer
  • Urothelial Carcinoma
  • Upper Tract Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
* 18 years of age or older

- * English-speaking

- * Planned treatment with radical cystectomy or radical nephroureterectomy/ureterectomy with or without preceding systemic therapy as indicated by the patient's surgeon with enough time to complete a minimum of 4 weeks of exercises before surgery if enrolled in the (P)REHAB arm

- * Willing and able to participate in trial activities
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 Mini-mental Status Assessment - * 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 - * Inability to understand or read English - * Participants who have nonmuscle-invasive urothelial cancer of the bladder/upper tract anticipating undergoing organ-preserving treatments, or radiographic evidence of metastatic disease involving other organs including brain metastases. - * Patients with predominant histology other than urothelial carcinoma of the bladder or upper tracts (e.g. metastasis from another cancer) who would not otherwise be considered candidates for standard definitive or consolidative surgeries (radical cystectomy, ureterectomy, radical nephroureterectomy) with/without treatment with preoperative/neoadjuvant systemic therapy.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 - * No access to an Android or iOS smart device with the minimum criteria for using ExerciseRx. - * Not receiving surgery at UWMC - * Participation in a clinical trial that does not permit enrollment in the Get Moving trial.

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: [email protected]

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
[email protected]

Principal Investigator
Sarah Psutka