A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- University of Washington
- Study ID
- NCT06040762
- Status
- Recruiting
Conditions
- Bladder Cancer
- Renal Pelvis and Ureter Urothelial Carcinoma
- Upper Tract Urothelial Carcinoma
- Urothelial Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Best Practice — OTHERReceive SOC educational materials
- Exercise Intervention — OTHERReceive (P)REHAB exercise program
- App-Based Intervention — OTHERUse ExerciseRx app
- App-Based Intervention — OTHERUse FitBit app
- Interview — OTHERAncillary studies
- Wearable Activity Tracker — OTHERWear FitBit
- Physical Performance Testing — OTHERAncillary studies
- Questionnaire Administration — OTHERAncillary studies
Study Details
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.
Key Dates
- Start date
- Dec 19, 2023
- Status verified
- Feb 2026
- Primary completion
- Apr 30, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 128 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Arm A ([P]REHAB intervention)Starting at least 4 weeks prior to date of surgery, patients use the ExerciseRx 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 SOC chemotherapy, if applicable, prior to SOC surgery and for 90 days following surgery (total \~4-7 months). Patients also download the FitBit app and wear a FitBit throughout the study.
- Active Comparator: Arm B (standard of care)Patients receive SOC educational materials and, starting at least 4 weeks prior to date of surgery, patients wear a FitBit and use the FitBit app while receiving SOC chemotherapy, if applicable, prior to SOC surgery.
Primary Outcome Measure
Trial recruitment [ Time Frame: At enrollment ]
Central Contacts
- Get Moving Research Coordinator206-210-4040
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | Sarah Psutka (PRINCIPAL_INVESTIGATOR) |
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