A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients Receiving Chemotherapy Before Radical Cystectomy, Get Moving Trial
Muscle Invasive Bladder Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8
About this trial
This is an interventional supportive care trial for Muscle Invasive Bladder Carcinoma
Eligibility Criteria
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 cisplatin-based NAC 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 Contraindications to receiving intravesical NAC or RC. NAC is contraindicated in: Patients with baseline/preexisting renal dysfunction (e.g. creatinine clearance < 50 ml/min) Eastern Cooperative Oncology Group (ECOG) > 3 Immunosuppressed patients with congenital or acquired immune deficiency, whether due to concurrent disease (e.g. acquired immunodeficiency syndrome [AIDS], lymphoma, leukemia), concomitant cancer therapy (cytotoxic drugs, radiation), or immunosuppressive therapy (e.g. corticosteroids, disease-modifying antirheumatic drugs [DMARDs]) Hearing impairment: hearing loss or tinnitus >= 2 Grade 2 or greater neuropathy Hypersensitivity to platinum agents Pregnancy and lactation Human immunodeficiency virus (HIV)/AIDS (CD4 counts < 200 microL) 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
Sites / Locations
- Fred Hutch/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A ([P]REHAB intervention)
Arm B (standard of care)
Patients use the ExerciseRx app to follow the (P)REHAB exercise program, which consists of 4 20-30 minute home exercise sessions per week and personalized step count goal setting and tracking, during receipt of SOC NAC prior to SOC RC and for 90 days following surgery (total ~7 months). Patients download the Fitbit app and wear a FitBit throughout the study.
Patients receive SOC educational materials and wear a FitBit and use the FitBit app during receipt of SOC NAC prior to SOC RC and for 90 days following surgery (total ~7 months).