An interventional study of Best Practice and Exercise Intervention in Bladder Cancer, Urothelial Carcinoma and Upper Tract Urothelial Carcinoma, sponsored by University of Washington. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University of Washington · Not applicable, Interventional, and Supportive care
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.
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 Google Health 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 Google Health 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.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 128 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 Google Health app and wear a FitBit throughout the study.
Other: Exercise Intervention · Other: App-Based Intervention · Other: Interview · Other: Wearable Activity Tracker · Other: Physical Performance Testing · Other: Questionnaire Administration
Patients receive SOC educational materials and, starting at least 4 weeks prior to date of surgery, patients wear a FitBit and use the Google Health app while receiving SOC chemotherapy, if applicable, prior to SOC surgery.
Other: Best Practice · Other: App-Based Intervention · Other: Wearable Activity Tracker · Other: Physical Performance Testing · Other: Questionnaire Administration
Receive SOC educational materials
Also known as: standard of care, standard therapy
Receive (P)REHAB exercise program
Use ExerciseRx app
Use Google Health app
Ancillary studies
Wear FitBit
Ancillary studies
Also known as: Physical Fitness Testing, Physical Function Testing
Ancillary studies
Trial recruitment
Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) will be described via qualitative report.
Time frame: At enrollment
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).
Time frame: Through study completion, on average 4-7 months
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.
Time frame: From enrollment (T1) to 1-4 months post enrollment (before surgery) (T2)
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.
Time frame: From 1-4 months post enrollment (before surgery) (T2) to 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.
Time frame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
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.
Time frame: Through study completion, on average 7 months
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
Time frame: Through study completion, on average 7 months
Frailty
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
Time frame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Frailty
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
Time frame: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
Frailty
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
Time frame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3
Body composition - fat free mass
Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating the skeletal muscle index and fat mass index of deidentified computed tomography scans.
Time frame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Body composition - fat free mass
Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating the skeletal muscle index and fat mass index of deidentified computed tomography scans.
Time frame: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
Body composition - fat free mass
Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating the skeletal muscle index and fat mass index of deidentified computed tomography scans.
Time frame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
Body composition - fat mass
Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating fat mass index of deidentified computed tomography scans.
Time frame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Body composition - fat mass
Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating fat mass index of deidentified computed tomography scans.
Time frame: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
Body composition - fat mass
Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating fat mass index of deidentified computed tomography scans.
Time frame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
Patient-reported health-related quality of life
Patient reported health-related quality of life will be assessed by a change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)-C30. All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.
Time frame: At enrollment, 3-4 months from enrollment (before surgery), 4-7 months from enrollment (90 days post surgery)
Patient-reported health-related quality of life - bladder cancer specific
Bladder cancer-specific patient-reported health-related quality of life will be assessed by a change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-Bladder Cancer Muscle-Invasive 30). All subscale and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.
Time frame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
Patient-reported health-related quality of life - bladder cancer specific
Bladder cancer-specific patient-reported health-related quality of life will be assessed by a change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-Bladder Cancer Muscle-Invasive 30). All subscale and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.
Time frame: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)
Patient-reported health-related quality of life - bladder cancer specific
Bladder cancer-specific patient-reported health-related quality of life will be assessed by a change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-Bladder Cancer Muscle-Invasive 30). All subscale and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.
Time frame: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)
NAC-associated adverse events
Will be recorded as both physician-reported adverse events utilizing Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 5.0 and using the patient-reported CTCAE and will be described via qualitative report
Time frame: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)
(P)REHAB-associated adverse events
Will be assessed by comparing physician-reported CTCAE v. 5.0 adverse events (e.g. falls, pain score as measured using a visual analog scale 0-10, and fatigue), compared between the (P)REHAB and standard of care arms.
Time frame: At enrollment (T1), 3-4 months from enrollment (before surgery) (T2), 4-7 months from enrollment (90 days post surgery) (T3)
Number of participants with post-surgical complications within 90 days graded using the Clavien grading scale
Graded using the Clavien grading scale and reported qualitatively. The Clavien-Dindo Classification is a grading system used throughout surgery for classifying adverse events (complications) that occur as a result of surgical procedures. The system consists of five (I, II, III, IV and V) or seven (I, II, IIIa, IIIb, IVa, IVb and V) grades of severity, with Grade I being low and Grade V being death.
Time frame: Within 90 days of surgery
Surgical outcomes - length of stay
Surgical outcomes include length of stay following surgery. Surgical outcomes will be reported via qualitative report.
Time frame: Through study completion, on average 7 months
Surgical outcomes - post discharge disposition
Surgical outcomes include discharge disposition (e.g. discharge to home vs. short term nursing facility versus rehabilitation unit). For patients not discharged to home, will evaluate length of time in a skilled nursing facility or rehabilitation unit as necessary. Surgical outcomes will be reported via qualitative report
Time frame: Through study completion, on average 7 months
Average daily step count
Number of steps per day as measured by the FitBit wearable will be reported.
Time frame: Through study completion, on average 7 months
Provider perceived usability
Assessed using the System Usability Scale (SUS) score 0-100 with 100 being high usability, User Burden Scale (UBS) score 20-100 with 100 being high burden, and/or Intervention Usability Scale (IUS) score 0-100 with 100 being high usability.
Time frame: Up to 1 year
Provider perceived utility
Assessed using the System Usability Scale (SUS) score 0-100 with 100 being high usability, User Burden Scale (UBS) score 20-100 with 100 being high burden, and/or Intervention Usability Scale (IUS) score 0-100 with 100 being high usability.
Time frame: Up to 1 year
Plan to share: No
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