Clinical trial NCT06040762: A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Urothelial Carcinoma
Upper Tract Urothelial Carcinoma
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Bladder Cancer Advocacy Network
First posted: 2023-09-18
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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
* 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(s) that restricts participation in unsupervised home exercises, such as prior stroke with neurologic impairment, weight-bearing precautions, or unwillingness to participate in exercises
* 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
* Inability to understand or read English
* Lack of access or lack of sufficient facility to use 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

Primary outcomes:
measure: Trial recruitment
timeFrame: At enrollment
measure: Trial retention
timeFrame: Through study completion, on average 4-7 months
measure: Change in physical function
timeFrame: From enrollment (T1) to 1-4 months post enrollment (before surgery) (T2)
measure: Change in physical function
timeFrame: From 1-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
measure: Change in physical function
timeFrame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
Secondary outcomes:
measure: Protocol adherence
timeFrame: Through study completion, on average 7 months
measure: Patient experience with use of ExerciseRx app, including app engagement ([P]REHAB arm only) (feasibility)
timeFrame: Through study completion, on average 7 months
measure: Frailty
timeFrame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
measure: Frailty
timeFrame: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
measure: Frailty
timeFrame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3
measure: Body composition - fat free mass
timeFrame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
measure: Body composition - fat free mass
timeFrame: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
measure: Body composition - fat free mass
timeFrame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
measure: Body composition - fat mass
timeFrame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
measure: Body composition - fat mass
timeFrame: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
measure: Body composition - fat mass
timeFrame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
measure: Patient-reported health-related quality of life
timeFrame: At enrollment, 3-4 months from enrollment (before surgery), 4-7 months from enrollment (90 days post surgery)
measure: Patient-reported health-related quality of life - bladder cancer specific
timeFrame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
measure: Patient-reported health-related quality of life - bladder cancer specific
timeFrame: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
measure: Patient-reported health-related quality of life - bladder cancer specific
timeFrame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
measure: NAC-associated adverse events
timeFrame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
measure: (P)REHAB-associated adverse events
timeFrame: At enrollment (T1), 3-4 months from enrollment (before surgery) (T2), 4-7 months from enrollment (90 days post surgery) (T3)
measure: Number of participants with post-surgical complications within 90 days graded using the Clavien grading scale
timeFrame: Within 90 days of surgery
measure: Surgical outcomes - length of stay
timeFrame: Through study completion, on average 7 months
measure: Surgical outcomes - post discharge disposition
timeFrame: Through study completion, on average 7 months
measure: Average daily step count
timeFrame: Through study completion, on average 7 months
measure: Average daily sedentary time
timeFrame: Through study completion, on average 7 months
measure: Provider perceived usability
timeFrame: Up to 1 year
measure: Provider perceived utility
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Sarah Psutka
role: PRINCIPAL_INVESTIGATOR
References: