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/NCT05978570</url>
    </required_header>
    <id_info>
      <org_study_id>LCCC2251</org_study_id>
      <nct_id>NCT05978570</nct_id>
    </id_info>
    <brief_title>Physical Therapy in Pre-cystectomy Patients</brief_title>
    <official_title>Assessing the Impact of Physical Therapy in the Pre-cystectomy Pathway in Patients With Bladder Cancer on Patient Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>UNC Lineberger Comprehensive Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>UNC Lineberger Comprehensive Cancer Center</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>
        This single-site, non-randomized, interventional study evaluates the impact of a physical&#xD;
        therapy consultation for patients with bladder cancer scheduled for radical cystectomy (RC).&#xD;
        The purpose of this study is to investigate whether consultation with a physical therapist&#xD;
        and the development of a personally tailored exercise program in the pre-cystectomy period&#xD;
        for patients with bladder cancer will result in reduced post-operative complications,&#xD;
        morbidity, length of inpatient stay, improve readmission 30-day and 90-day and improve 90-day&#xD;
        mortality. This study will be partially retrospective (pre-implementation of a physical&#xD;
        therapy consultation order) and partially prospective.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 27, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Thirty-day readmission rates</measure>
      <time_frame>Up to 30 days after the date of cystectomy</time_frame>
      <description>Thirty-day readmission rates will be defined as the comparison of the number of hospital admission after physical therapy consultation and tailored exercises and historical hospital admission data.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The proportion of individuals who received a physical therapy consultation</measure>
      <time_frame>1 day (the date of cystectomy)</time_frame>
      <description>The feasibility of implementing a physical therapy consultation and tailored exercise program in the pre-cystectomy treatment pathway will be determined by calculating the proportion of individuals who received a physical therapy consultation in the prospective group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ninety-day readmission rates</measure>
      <time_frame>Up to 90 days after the date of cystectomy</time_frame>
      <description>Ninety-day readmission rates will be defined as the comparison of the number of hospital admission after physical therapy consultation and tailored exercises and historical hospital admission data.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute care length of stay</measure>
      <time_frame>Starting to the exercises to up to 90 days after the date of cystectomy</time_frame>
      <description>Acute care length of stay will be defined as comparing number of hospital day stay after physical therapy consultation and tailored exercises and historical hospital admission data.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality rates</measure>
      <time_frame>Up to 90 days after the date of cystectomy</time_frame>
      <description>Mortality rates will be defined as the comparison of the number of subjects who died after physical therapy consultation and tailored exercises and historical hospital admission data.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-cystectomy complication types and rates</measure>
      <time_frame>Up to 90 days after the date of cystectomy</time_frame>
      <description>Post-cystectomy complication types and rates will be defined as comparison of the numbers and types of complications after physical therapy consultation with tailored exercises and historical data.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Bladder Cancer</condition>
    <arm_group>
      <arm_group_label>A personally tailored exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A personally tailored exercise program will be offered to the participants after the Physical Therapy assessment, before the surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>A personally tailored exercise program</intervention_name>
      <description>A personally tailored exercise program will be offered to the participants after Physical Therapy assessment, before the surgery.</description>
      <arm_group_label>A personally tailored exercise</arm_group_label>
      <other_name>Exercise</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          In order to participate in this study a subject must meet all of the eligibility criteria&#xD;
          outlined below:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years at the time of bladder cancer diagnosis&#xD;
  &#xD;
            2. History of bladder cancer&#xD;
  &#xD;
            3. Performance of radical cystectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. No history of bladder cancer or radical cystectomy&#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>Sasha Knowlton</last_name>
      <role>Principal Investigator</role>
      <affiliation>Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sasha Knowlton</last_name>
      <phone>984 974 0293</phone>
      <email>sknow@email.unc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sasha Knowlton</last_name>
      </contact>
      <investigator>
        <last_name>Sasha E Knowlton, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://unclineberger.org/patientcare/clinical-trials/clinical-trials</url>
      <description>University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>radical cystectomy</keyword>
    <keyword>physical therapy</keyword>
    <keyword>exercise program</keyword>
    <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/NCT05978570
  org study id: LCCC2251
  nct id: NCT05978570
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This single-site, non-randomized, interventional study evaluates the impact of a physical
        therapy consultation for patients with bladder cancer scheduled for radical cystectomy (RC).
        The purpose of this study is to investigate whether consultation with a physical therapist
        and the development of a personally tailored exercise program in the pre-cystectomy period
        for patients with bladder cancer will result in reduced post-operative complications,
        morbidity, length of inpatient stay, improve readmission 30-day and 90-day and improve 90-day
        mortality. This study will be partially retrospective (pre-implementation of a physical
        therapy consultation order) and partially prospective.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Thirty-day readmission rates
  time frame: Up to 30 days after the date of cystectomy
  description: Thirty-day readmission rates will be defined as the comparison of the number of hospital admission after physical therapy consultation and tailored exercises and historical hospital admission data.
  measure: The proportion of individuals who received a physical therapy consultation
  time frame: 1 day (the date of cystectomy)
  description: The feasibility of implementing a physical therapy consultation and tailored exercise program in the pre-cystectomy treatment pathway will be determined by calculating the proportion of individuals who received a physical therapy consultation in the prospective group.
  measure: Ninety-day readmission rates
  time frame: Up to 90 days after the date of cystectomy
  description: Ninety-day readmission rates will be defined as the comparison of the number of hospital admission after physical therapy consultation and tailored exercises and historical hospital admission data.
  measure: Acute care length of stay
  time frame: Starting to the exercises to up to 90 days after the date of cystectomy
  description: Acute care length of stay will be defined as comparing number of hospital day stay after physical therapy consultation and tailored exercises and historical hospital admission data.
  measure: Mortality rates
  time frame: Up to 90 days after the date of cystectomy
  description: Mortality rates will be defined as the comparison of the number of subjects who died after physical therapy consultation and tailored exercises and historical hospital admission data.
  measure: Post-cystectomy complication types and rates
  time frame: Up to 90 days after the date of cystectomy
  description: Post-cystectomy complication types and rates will be defined as comparison of the numbers and types of complications after physical therapy consultation with tailored exercises and historical data.
  arm group label: A personally tailored exercise
  arm group type: Experimental
  description: A personally tailored exercise program will be offered to the participants after the Physical Therapy assessment, before the surgery.
  intervention type: Other
  intervention name: A personally tailored exercise program
  description: A personally tailored exercise program will be offered to the participants after Physical Therapy assessment, before the surgery.
  arm group label: A personally tailored exercise
  other name: Exercise
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sasha Knowlton
  role: Principal Investigator
  affiliation: Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
  last name: Sasha Knowlton
  phone: 984 974 0293
  email: sknow@email.unc.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: http://unclineberger.org/patientcare/clinical-trials/clinical-trials
  description: University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
  responsible party type: Sponsor
  mesh term: Urinary Bladder Neoplasms
  sharing ipd: No