xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040762</url>
    </required_header>
    <id_info>
      <org_study_id>RG1123479</org_study_id>
      <secondary_id>NCI-2023-05596</secondary_id>
      <secondary_id>RG1123479</secondary_id>
      <nct_id>NCT06040762</nct_id>
    </id_info>
    <brief_title>A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients Receiving Chemotherapy Before Radical Cystectomy, Get Moving Trial</brief_title>
    <official_title>The &quot;Get Moving Trial&quot;: A Phase I/II RCT of Home-Based (P)Rehabilitation With ExerciseRx in Muscle-Invasive Bladder Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bladder Cancer Advocacy Network</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Washington</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Prehabilitation refers to the process of improving a patient's functional capabilities prior&#xD;
        to a surgical procedure with the goal of decreasing post-surgical inactivity and physical&#xD;
        decline. This phase I/II trial evaluates the utility of a personalized home-based&#xD;
        prehabilitation exercise intervention for the improvement of physical function and surgical&#xD;
        outcomes in patients receiving chemotherapy before routine radical cystectomy for localized&#xD;
        (non-metastatic) muscle-invasive bladder cancer. The exercise intervention includes at-home&#xD;
        exercise sessions focused on the improvement of core strength and balance as well as&#xD;
        personalized step count goals, delivered to patients remotely via a smart-device-based&#xD;
        application (ExerciseRx). Encouraging physical activity before surgery may improve physical&#xD;
        function and surgical outcomes in patients who are scheduled to undergo surgery for their&#xD;
        non-metastatic muscle-invasive bladder cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        OUTLINE: Patients are randomized to 1 of 2 arms and are followed from enrollment through&#xD;
        neoadjuvant chemotherapy receipt, radical cystectomy, and for 90 days following surgery&#xD;
        (total estimated time on study: ~7 months)&#xD;
  &#xD;
        ARM A: Patients use the ExerciseRx application (app) to follow the (P)REHAB exercise program,&#xD;
        which consists of four 20-30 minute home exercise sessions per week and personalized step&#xD;
        count goal setting and tracking, while receiving standard of care (SOC) NAC prior to SOC&#xD;
        radical cystectomy (RC), and for 90 days following surgery. Patients also wear a FitBit and&#xD;
        use the FitBit app on study.&#xD;
  &#xD;
        ARM B: Patients receive SOC educational materials and wear a FitBit and use the FitBit app&#xD;
        while receiving SOC NAC prior to SOC RC.&#xD;
  &#xD;
        After completion of study intervention, patients are followed up at 90 days following SOC RC.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">April 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">April 15, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in physical function</measure>
      <time_frame>From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in physical function</measure>
      <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)</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in physical function</measure>
      <time_frame>From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Trial recruitment</measure>
      <time_frame>At enrollment</time_frame>
      <description>Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) will be described via qualitative report.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trial retention</measure>
      <time_frame>Through study completion, on average 7 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Protocol adherence</measure>
      <time_frame>Through study completion, on average 7 months</time_frame>
      <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 &gt;=70% of all exercise activities (goal 4x weekly, 20-30min/session) as measured using the ExerciseRx app.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient experience with use of ExerciseRx app, including app engagement ([P]REHAB arm only) (feasibility)</measure>
      <time_frame>Through study completion, on average 7 months</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frailty</measure>
      <time_frame>From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)</time_frame>
      <description>Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frailty</measure>
      <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)</time_frame>
      <description>Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frailty</measure>
      <time_frame>From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)</time_frame>
      <description>Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition - fat free mass</measure>
      <time_frame>From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition - fat free mass</measure>
      <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)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition - fat free mass</measure>
      <time_frame>From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition - fat mass</measure>
      <time_frame>From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition - fat mass</measure>
      <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)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition - fat mass</measure>
      <time_frame>From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported health-related quality of life</measure>
      <time_frame>At enrollment, 3-4 months from enrollment (after NAC and before RC), 6-7 months from enrollment (90 days post RC)</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported health-related quality of life - bladder cancer specific</measure>
      <time_frame>From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported health-related quality of life - bladder cancer specific</measure>
      <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)</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported health-related quality of life - bladder cancer specific</measure>
      <time_frame>From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NAC-associated adverse events</measure>
      <time_frame>From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(P)REHAB-associated adverse events</measure>
      <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)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with post-surgical complications within 90 days graded using the Clavien grading scale</measure>
      <time_frame>Within 90 days of RC</time_frame>
      <description>Graded using the Clavien grading scale and reported qualitatively.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgical outcomes - length of stay</measure>
      <time_frame>Through study completion, on average 7 months</time_frame>
      <description>Surgical outcomes include length of stay following RC.Surgical outcomes will be reported via qualitative report</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgical outcomes - post discharge disposition</measure>
      <time_frame>Through study completion, on average 7 months</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average daily step count</measure>
      <time_frame>Through study completion, on average 7 months</time_frame>
      <description>Number of steps per day as measured by the FitBit wearable will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average daily sedentary time</measure>
      <time_frame>Through study completion, on average 7 months</time_frame>
      <description>Average daily sedentary time as measured by the FitBit wearable will be reported.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Muscle Invasive Bladder Carcinoma</condition>
    <condition>Stage II Bladder Cancer AJCC v8</condition>
    <condition>Stage IIIA Bladder Cancer AJCC v8</condition>
    <arm_group>
      <arm_group_label>Arm A ([P]REHAB intervention)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B (standard of care)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Best Practice</intervention_name>
      <description>Receive SOC educational materials</description>
      <arm_group_label>Arm B (standard of care)</arm_group_label>
      <other_name>standard of care</other_name>
      <other_name>standard therapy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise Intervention</intervention_name>
      <description>Receive (P)REHAB exercise program</description>
      <arm_group_label>Arm A ([P]REHAB intervention)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>App-Based Intervention</intervention_name>
      <description>Use ExerciseRx app</description>
      <arm_group_label>Arm A ([P]REHAB intervention)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>App-Based Intervention</intervention_name>
      <description>Use FitBit app</description>
      <arm_group_label>Arm A ([P]REHAB intervention)</arm_group_label>
      <arm_group_label>Arm B (standard of care)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Interview</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm A ([P]REHAB intervention)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Wearable Activity Tracker</intervention_name>
      <description>Wear FitBit</description>
      <arm_group_label>Arm A ([P]REHAB intervention)</arm_group_label>
      <arm_group_label>Arm B (standard of care)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical Performance Testing</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm A ([P]REHAB intervention)</arm_group_label>
      <arm_group_label>Arm B (standard of care)</arm_group_label>
      <other_name>Physical Fitness Testing</other_name>
      <other_name>Physical Function Testing</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm A ([P]REHAB intervention)</arm_group_label>
      <arm_group_label>Arm B (standard of care)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
            -  Diagnosis of American Urological Association (AUA) nonmetastatic muscle-invasive&#xD;
               bladder cancer (MIBC) (e.g. American Joint Committee on Cancer [AJCC] pT2-4 N0-1 M0)&#xD;
  &#xD;
            -  Patients who have been indicated for cisplatin-based NAC followed by RC in&#xD;
               shared-decision-making with their primary urologist and medical oncologist&#xD;
  &#xD;
            -  Have a smart device meeting study criteria or willing to use a study-supplied smart&#xD;
               device&#xD;
  &#xD;
            -  Willing and able to participate in trial activities&#xD;
  &#xD;
            -  Able to understand and willing to sign written informed consent in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cognitive/mental impairment that will preclude ability to participate in routine&#xD;
               exercise activities. Significant cognitive or memory impairment or baseline dementia&#xD;
               that would preclude a patient's ability to follow instructions or reproduce exercises&#xD;
               as characterized by scoring &lt; 24 on the Minimental Status Examination&#xD;
  &#xD;
            -  Immobility, inability/unwillingness to perform personalized exercise program.&#xD;
               Inability to perform exercises safely from seated or standing position at home or&#xD;
               recent falls or high fall risk. Neurologic or orthopedic condition that restricts&#xD;
               participation in unsupervised home exercises, such as prior stroke with neurologic&#xD;
               impairment, weight bearing precautions, unwillingness to participate in exercises&#xD;
  &#xD;
            -  Participants who have nonmuscle-invasive bladder cancer, or radiographic evidence of&#xD;
               metastatic disease involving other organs including brain metastases. Patients with&#xD;
               predominant histology other than urothelial carcinoma of the bladder who would not&#xD;
               otherwise be considered candidates for NAC or RC&#xD;
  &#xD;
            -  Contraindications to receiving intravesical NAC or RC. NAC is contraindicated in:&#xD;
  &#xD;
                 -  Patients with baseline/preexisting renal dysfunction (e.g. creatinine clearance &lt;&#xD;
                    50 ml/min)&#xD;
  &#xD;
                 -  Eastern Cooperative Oncology Group (ECOG) &gt; 3&#xD;
  &#xD;
                 -  Immunosuppressed patients with congenital or acquired immune deficiency, whether&#xD;
                    due to concurrent disease (e.g. acquired immunodeficiency syndrome [AIDS],&#xD;
                    lymphoma, leukemia), concomitant cancer therapy (cytotoxic drugs, radiation), or&#xD;
                    immunosuppressive therapy (e.g. corticosteroids, disease-modifying antirheumatic&#xD;
                    drugs [DMARDs])&#xD;
  &#xD;
                 -  Hearing impairment: hearing loss or tinnitus &gt;= 2&#xD;
  &#xD;
                 -  Grade 2 or greater neuropathy&#xD;
  &#xD;
                 -  Hypersensitivity to platinum agents&#xD;
  &#xD;
                 -  Pregnancy and lactation&#xD;
  &#xD;
                 -  Human immunodeficiency virus (HIV)/AIDS (CD4 counts &lt; 200 microL)&#xD;
  &#xD;
            -  Uncontrolled or concurrent illness including, but not limited to, ongoing or active&#xD;
               infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
               arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
               study requirements&#xD;
  &#xD;
            -  Pregnant women are excluded from this study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sarah Psutka</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ellie Brewer, MPH</last_name>
      <phone>206-210-4040</phone>
      <email>GetMoving@uw.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fred Hutch/University of Washington Cancer Consortium</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98109</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ellie Brewer, MPH</last_name>
        <phone>206-210-4040</phone>
        <email>GetMoving@uw.edu</email>
      </contact>
      <investigator>
        <last_name>Sarah Psutka</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040762
  org study id: RG1123479
  secondary id: NCI-2023-05596
  secondary id: RG1123479
  nct id: NCT06040762
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Change in physical function
  time frame: From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)
  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.
  measure: Change in physical function
  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)
  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.
  measure: Change in physical function
  time frame: From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)
  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.
  measure: Trial recruitment
  time frame: At enrollment
  description: Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) will be described via qualitative report.
  measure: Trial retention
  time frame: Through study completion, on average 7 months
  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.
  measure: Protocol adherence
  time frame: Through study completion, on average 7 months
  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.
  measure: Patient experience with use of ExerciseRx app, including app engagement ([P]REHAB arm only) (feasibility)
  time frame: Through study completion, on average 7 months
  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
  measure: Frailty
  time frame: From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)
  description: Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
  measure: Frailty
  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)
  description: Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
  measure: Frailty
  time frame: From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)
  description: Frailty will be assessed using the Cancer and Aging Resilience Geriatric Assessment.
  measure: Body composition - fat free mass
  time frame: From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)
  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.
  measure: Body composition - fat free mass
  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)
  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.
  measure: Body composition - fat free mass
  time frame: From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)
  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.
  measure: Body composition - fat mass
  time frame: From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)
  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.
  measure: Body composition - fat mass
  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)
  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.
  measure: Body composition - fat mass
  time frame: From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)
  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.
  measure: Patient-reported health-related quality of life
  time frame: At enrollment, 3-4 months from enrollment (after NAC and before RC), 6-7 months from enrollment (90 days post RC)
  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
  measure: Patient-reported health-related quality of life - bladder cancer specific
  time frame: From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)
  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).
  measure: Patient-reported health-related quality of life - bladder cancer specific
  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)
  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).
  measure: Patient-reported health-related quality of life - bladder cancer specific
  time frame: From enrollment (T1) to 6-7 months post enrollment (90 days post RC) (T3)
  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).
  measure: NAC-associated adverse events
  time frame: From enrollment (T1) to 3-4 months post enrollment (after NAC and before RC) (T2)
  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
  measure: (P)REHAB-associated adverse events
  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)
  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.
  measure: Number of participants with post-surgical complications within 90 days graded using the Clavien grading scale
  time frame: Within 90 days of RC
  description: Graded using the Clavien grading scale and reported qualitatively.
  measure: Surgical outcomes - length of stay
  time frame: Through study completion, on average 7 months
  description: Surgical outcomes include length of stay following RC.Surgical outcomes will be reported via qualitative report
  measure: Surgical outcomes - post discharge disposition
  time frame: Through study completion, on average 7 months
  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
  measure: Average daily step count
  time frame: Through study completion, on average 7 months
  description: Number of steps per day as measured by the FitBit wearable will be reported.
  measure: Average daily sedentary time
  time frame: Through study completion, on average 7 months
  description: Average daily sedentary time as measured by the FitBit wearable will be reported.
  arm group label: Arm A ([P]REHAB intervention)
  arm group type: Experimental
  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 group label: Arm B (standard of care)
  arm group type: Active Comparator
  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: Best Practice
  description: Receive SOC educational materials
  arm group label: Arm B (standard of care)
  other name: standard of care
  other name: standard therapy
  intervention type: Other
  intervention name: Exercise Intervention
  description: Receive (P)REHAB exercise program
  arm group label: Arm A ([P]REHAB intervention)
  intervention type: Other
  intervention name: App-Based Intervention
  description: Use ExerciseRx app
  arm group label: Arm A ([P]REHAB intervention)
  intervention type: Other
  intervention name: App-Based Intervention
  description: Use FitBit app
  arm group label: Arm A ([P]REHAB intervention)
  arm group label: Arm B (standard of care)
  intervention type: Other
  intervention name: Interview
  description: Ancillary studies
  arm group label: Arm A ([P]REHAB intervention)
  intervention type: Other
  intervention name: Wearable Activity Tracker
  description: Wear FitBit
  arm group label: Arm A ([P]REHAB intervention)
  arm group label: Arm B (standard of care)
  intervention type: Other
  intervention name: Physical Performance Testing
  description: Ancillary studies
  arm group label: Arm A ([P]REHAB intervention)
  arm group label: Arm B (standard of care)
  other name: Physical Fitness Testing
  other name: Physical Function Testing
  intervention type: Other
  intervention name: Questionnaire Administration
  description: Ancillary studies
  arm group label: Arm A ([P]REHAB intervention)
  arm group label: Arm B (standard of care)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sarah Psutka
  role: Principal Investigator
  affiliation: Fred Hutch/University of Washington Cancer Consortium
  last name: Ellie Brewer, MPH
  phone: 206-210-4040
  email: GetMoving@uw.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Urinary Bladder Neoplasms
  sharing ipd: No