The "Get Moving Trial": A Phase I/II RCT of Home-Based (P)Rehabilitation With ExerciseRx in Bladder Cancer and Upper Tract Urothelial Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- University of Washington
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Trial recruitment
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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: Starting at least 4 weeks prior to date of surgery, 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, while receiving standard of care (SOC) chemotherapy, if applicable, prior to 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, 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. After completion of study intervention, patients are followed up at 90 days following SOC surgery.
Investigators
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
Outcomes
Primary Outcomes
Trial recruitment
Time Frame: At enrollment
Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) will be described via qualitative report.
Trial retention
Time Frame: Through study completion, on average 4-7 months
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
Time Frame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
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.
Secondary Outcomes
- Patient experience with use of ExerciseRx app, including app engagement ([P]REHAB arm only) (feasibility)(Through study completion, on average 7 months)
- Number of participants with post-surgical complications within 90 days graded using the Clavien grading scale(Within 90 days of surgery)
- Surgical outcomes - post discharge disposition(Through study completion, on average 7 months)
- Provider perceived usability(Up to 1 year)
- Body composition - fat free mass(From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3))
- Patient-reported health-related quality of life - bladder cancer specific(From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3))
- Frailty(From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
- Body composition - fat mass(From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3))
- Patient-reported health-related quality of life(At enrollment, 3-4 months from enrollment (before surgery), 4-7 months from enrollment (90 days post surgery))
- NAC-associated adverse events(From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2))
- (P)REHAB-associated adverse events(At enrollment (T1), 3-4 months from enrollment (before surgery) (T2), 4-7 months from enrollment (90 days post surgery) (T3))
- Protocol adherence(Through study completion, on average 7 months)
- Surgical outcomes - length of stay(Through study completion, on average 7 months)
- Average daily step count(Through study completion, on average 7 months)
- Provider perceived utility(Up to 1 year)
- Average daily sedentary time(Through study completion, on average 7 months)