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.
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
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.
Parallel
Best Practice
Other interventionReceive SOC educational materials
Exercise Intervention
Other interventionReceive (P)REHAB exercise program
App-Based Intervention
Other interventionUse ExerciseRx app
App-Based Intervention
Other interventionUse Google Health app
Interview
Other interventionAncillary studies
Wearable Activity Tracker
Other interventionWear FitBit
Physical Performance Testing
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Trial recruitment
Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) will be described via qualitative report.
Trial retention
Trial retention (proportion retained versus all enrolled, reason for not completing) will be described via qualitative report. Successful retention is defined as continued participation within the trial until 4-7 months post enrollment (90 days post surgery) (T3).
Change in physical function
Physical function will be measured by the Short Performance Physical Battery (SPPB). Change in physical function will be measured and compared between the (P)REHAB and standard of care arms. SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with possible sarcopenia but no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. Persons with a score of 2 or lower who have sarcopenia, potential cachexia, and mobility disability are determined to be disabled.
Change in physical function
Physical function will be measured by the Short Performance Physical Battery (SPPB). Change in physical function will be measured and compared between the (P)REHAB and standard of care arms. SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with possible sarcopenia but no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. Persons with a score of 2 or lower who have sarcopenia, potential cachexia, and mobility disability are determined to be disabled.
Protocol adherence
Protocol adherence (proportion adhered versus all enrolled, specifics for how protocol was not followed and why) will be described via qualitative report. Protocol adherence for the (P)REHAB arm is defined as completion of \>=70% of all exercise activities (goal 4x weekly, 20-30min/session) as measured using the ExerciseRx app.
Patient experience with use of ExerciseRx app, including app engagement ([P]REHAB arm only) (feasibility)
Qualitative experience will be assessed by Zoom interviews (usability interview) with a subset of volunteer participants from the (P)REHAB arm and app engagement will be assessed by an affinity analysis of the MAUQ
Frailty
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
Frailty
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
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University of Washington
Lead sponsor
Bladder Cancer Advocacy Network
Collaborator
