A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients Receiving Chemotherapy Before Radical Cystectomy, Get Moving Trial
Study Details
Study Description
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 phase I/II trial evaluates the utility of a personalized home-based prehabilitation exercise intervention for the improvement of physical function and surgical outcomes in patients receiving chemotherapy before routine radical cystectomy for localized (non-metastatic) muscle-invasive bladder cancer. 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 non-metastatic muscle-invasive bladder cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
OUTLINE: Patients are randomized to 1 of 2 arms and are followed from enrollment through neoadjuvant chemotherapy receipt, radical cystectomy, and for 90 days following surgery (total estimated time on study: ~7 months)
ARM A: 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 and personalized step count goal setting and tracking, while receiving standard of care (SOC) NAC prior to SOC radical cystectomy (RC), 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 wear a FitBit and use the FitBit app while receiving SOC NAC prior to SOC RC.
After completion of study intervention, patients are followed up at 90 days following SOC RC.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A ([P]REHAB intervention) 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. |
Other: Exercise Intervention
Receive (P)REHAB exercise program
Other: App-Based Intervention
Use ExerciseRx app
Other: App-Based Intervention
Use FitBit app
Other: Interview
Ancillary studies
Other: Wearable Activity Tracker
Wear FitBit
Other: Physical Performance Testing
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
| Active Comparator: Arm B (standard of care) 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). |
Other: Best Practice
Receive SOC educational materials
Other Names:
Other: App-Based Intervention
Use FitBit app
Other: Wearable Activity Tracker
Wear FitBit
Other: Physical Performance Testing
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Change in physical function [From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)]
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 [From 3-4 months post enrollment (after NAC and before RC) (T2) to 6-7 months post enrollment (90 days post RC) (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.
- Change in physical function [From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (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 Outcome Measures
- Trial recruitment [At enrollment]
Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) will be described via qualitative report.
- Trial retention [Through study completion, on average 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 T3.
- Protocol adherence [Through study completion, on average 7 months]
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) [Through study completion, on average 7 months]
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 [From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)]
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
- Frailty [From 3-4 months post enrollment (after NAC and before RC) (T2) to 6-7 months post enrollment (90 days post RC) (T3)]
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
- Frailty [From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)]
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
- Body composition - fat free mass [From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)]
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.
- Body composition - fat free mass [From 3-4 months post enrollment (after NAC and before RC) (T2) to 6-7 months post enrollment (90 days post RC) (T3)]
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.
- Body composition - fat free mass [From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)]
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.
- Body composition - fat mass [From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)]
Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating fat mass index of deidentified computed tomography scans.
- Body composition - fat mass [From 3-4 months post enrollment (after NAC and before RC) (T2) to 6-7 months post enrollment (90 days post RC) (T3)]
Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating fat mass index of deidentified computed tomography scans.
- Body composition - fat mass [From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)]
Body composition will be measured using a validated, supervised machine learning body composition segmentation algorithm evaluating fat mass index of deidentified computed tomography scans.
- Patient-reported health-related quality of life [At enrollment, 3-4 months from enrollment (after NAC and before RC), 6-7 months from enrollment (90 days post RC)]
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. Values represent absolute changes from week 1 to 6 of treatment.
- Patient-reported health-related quality of life - bladder cancer specific [From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)]
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 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. Values represent absolute changes from week 1 to 6 of treatment.
- Patient-reported health-related quality of life - bladder cancer specific [From 3-4 months post enrollment (after NAC and before RC) (T2) to 6-7 months post enrollment (90 days post RC) (T3)]
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 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. Values represent absolute changes from week 1 to 6 of treatment.
- Patient-reported health-related quality of life - bladder cancer specific [From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)]
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 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. Values represent absolute changes from week 1 to 6 of treatment.
- NAC-associated adverse events [From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)]
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
- (P)REHAB-associated adverse events [At enrollment (T1), 3-4 months from enrollment (after NAC and before RC) (T2), 6-7 months from enrollment (90 days post RC) (T3)]
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.
- Number of participants with post-surgical complications within 90 days graded using the Clavien grading scale [Within 90 days of RC]
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.
- Surgical outcomes - length of stay [Through study completion, on average 7 months]
Surgical outcomes include length of stay following RC. Surgical outcomes will be reported via qualitative report
- Surgical outcomes - post discharge disposition [Through study completion, on average 7 months]
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
- Average daily step count [Through study completion, on average 7 months]
Number of steps per day as measured by the FitBit wearable will be reported.
- Average daily sedentary time [Through study completion, on average 7 months]
Average daily sedentary time as measured by the FitBit wearable will be reported.
Eligibility Criteria
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)
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Patients who have been indicated for cisplatin-based NAC followed by RC in shared-decision-making with their primary urologist and medical oncologist
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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:
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Patients with baseline/preexisting renal dysfunction (e.g. creatinine clearance < 50 ml/min)
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Eastern Cooperative Oncology Group (ECOG) > 3
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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])
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Hearing impairment: hearing loss or tinnitus >= 2
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Grade 2 or greater neuropathy
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Hypersensitivity to platinum agents
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Pregnancy and lactation
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Human immunodeficiency virus (HIV)/AIDS (CD4 counts < 200 microL)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- University of Washington
- Bladder Cancer Advocacy Network
Investigators
- Principal Investigator: Sarah Psutka, Fred Hutch/University of Washington Cancer Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG1123479
- NCI-2023-05596
- RG1123479