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A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients Receiving Chemotherapy Before Radical Cystectomy, Get Moving Trial

Primary Purpose

Muscle Invasive Bladder Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Exercise Intervention
App-Based Intervention
App-Based Intervention
Interview
Wearable Activity Tracker
Physical Performance Testing
Questionnaire Administration
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscle Invasive Bladder Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Arm A ([P]REHAB intervention)

Arm B (standard of care)

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Trial recruitment
Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) will be described via qualitative report.
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 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.
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
Frailty
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
Frailty
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
Frailty
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
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.
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.
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.
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.
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.
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.
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. Values represent absolute changes from week 1 to 6 of treatment.
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 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
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
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
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
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
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
Surgical outcomes include length of stay following RC. Surgical outcomes will be reported via qualitative report
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
Average daily step count
Number of steps per day as measured by the FitBit wearable will be reported.
Average daily sedentary time
Average daily sedentary time as measured by the FitBit wearable will be reported.

Full Information

First Posted
August 21, 2023
Last Updated
October 18, 2023
Sponsor
University of Washington
Collaborators
Bladder Cancer Advocacy Network
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1. Study Identification

Unique Protocol Identification Number
NCT06040762
Brief Title
A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients Receiving Chemotherapy Before Radical Cystectomy, Get Moving Trial
Official Title
The "Get Moving Trial": A Phase I/II RCT of Home-Based (P)Rehabilitation With ExerciseRx in Muscle-Invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
April 15, 2026 (Anticipated)
Study Completion Date
April 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
Bladder Cancer Advocacy Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 clinical 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Invasive Bladder Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A ([P]REHAB intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B (standard of care)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive SOC educational materials
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Receive (P)REHAB exercise program
Intervention Type
Other
Intervention Name(s)
App-Based Intervention
Intervention Description
Use ExerciseRx app
Intervention Type
Other
Intervention Name(s)
App-Based Intervention
Intervention Description
Use FitBit app
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Wearable Activity Tracker
Intervention Description
Wear FitBit
Intervention Type
Other
Intervention Name(s)
Physical Performance Testing
Other Intervention Name(s)
Physical Fitness Testing, Physical Function Testing
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in physical function
Description
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 3-4 months post enrollment (after NAC and before RC) (T2)
Title
Change in physical function
Description
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 3-4 months post enrollment (after NAC and before RC) (T2) to 6-7 months post enrollment (90 days post RC) (T3)
Title
Change in physical function
Description
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 6-7 months post enrollment (90 days post RC) (T3)
Secondary Outcome Measure Information:
Title
Trial recruitment
Description
Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) will be described via qualitative report.
Time Frame
At enrollment
Title
Trial retention
Description
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.
Time Frame
Through study completion, on average 7 months
Title
Protocol adherence
Description
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
Title
Patient experience with use of ExerciseRx app, including app engagement ([P]REHAB arm only) (feasibility)
Description
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
Title
Frailty
Description
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
Time Frame
From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)
Title
Frailty
Description
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
Time Frame
From 3-4 months post enrollment (after NAC and before RC) (T2) to 6-7 months post enrollment (90 days post RC) (T3)
Title
Frailty
Description
Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
Time Frame
From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)
Title
Body composition - fat free mass
Description
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 (after NAC and before RC) (T2)
Title
Body composition - fat free mass
Description
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 (after NAC and before RC) (T2) to 6-7 months post enrollment (90 days post RC) (T3)
Title
Body composition - fat free mass
Description
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 6-7 months post enrollment (90 days post RC) (T3)
Title
Body composition - fat mass
Description
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 (after NAC and before RC) (T2)
Title
Body composition - fat mass
Description
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 (after NAC and before RC) (T2) to 6-7 months post enrollment (90 days post RC) (T3)
Title
Body composition - fat mass
Description
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 6-7 months post enrollment (90 days post RC) (T3)
Title
Patient-reported health-related quality of life
Description
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.
Time Frame
At enrollment, 3-4 months from enrollment (after NAC and before RC), 6-7 months from enrollment (90 days post RC)
Title
Patient-reported health-related quality of life - bladder cancer specific
Description
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.
Time Frame
From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)
Title
Patient-reported health-related quality of life - bladder cancer specific
Description
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.
Time Frame
From 3-4 months post enrollment (after NAC and before RC) (T2) to 6-7 months post enrollment (90 days post RC) (T3)
Title
Patient-reported health-related quality of life - bladder cancer specific
Description
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.
Time Frame
From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)
Title
NAC-associated adverse events
Description
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 (after NAC and before RC) (T2)
Title
(P)REHAB-associated adverse events
Description
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 (after NAC and before RC) (T2), 6-7 months from enrollment (90 days post RC) (T3)
Title
Number of participants with post-surgical complications within 90 days graded using the Clavien grading scale
Description
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 RC
Title
Surgical outcomes - length of stay
Description
Surgical outcomes include length of stay following RC. Surgical outcomes will be reported via qualitative report
Time Frame
Through study completion, on average 7 months
Title
Surgical outcomes - post discharge disposition
Description
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
Title
Average daily step count
Description
Number of steps per day as measured by the FitBit wearable will be reported.
Time Frame
Through study completion, on average 7 months
Title
Average daily sedentary time
Description
Average daily sedentary time as measured by the FitBit wearable will be reported.
Time Frame
Through study completion, on average 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellie Brewer, MPH
Phone
206-210-4040
Email
GetMoving@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Psutka
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellie Brewer, MPH
Phone
206-210-4040
Email
GetMoving@uw.edu
First Name & Middle Initial & Last Name & Degree
Sarah Psutka

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients Receiving Chemotherapy Before Radical Cystectomy, Get Moving Trial

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