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/NCT05978583</url>
    </required_header>
    <id_info>
      <org_study_id>LCCC2252</org_study_id>
      <nct_id>NCT05978583</nct_id>
    </id_info>
    <brief_title>Impact of Physical and Occupational Therapy Therapy in New BMT Patients</brief_title>
    <official_title>Assessing the Impact of Physical and Occupational Therapy for Patients Admitted for Bone Marrow Transplant on 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 is a single-site, non-randomized, interventional study designed to evaluate the impact&#xD;
        of adding physical and occupational therapy consultation upon inpatient admission for a bone&#xD;
        marrow transplantation (BMT). The purpose of this study is to investigate whether&#xD;
        consultation with physical and occupational therapists as part of the general admission order&#xD;
        set for patients scheduled for bone marrow transplant will result in reduced complications,&#xD;
        morbidity, length of inpatient stay, 30-day readmission and 90-day mortality. Baseline data&#xD;
        collection will be used to determine eligibility. This study will be partially retrospective&#xD;
        (pre-implementation of physical and occupational therapy consultation order) and partially&#xD;
        prospective.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 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>30-day readmission</measure>
      <time_frame>Up to 30 days after bone marrow transplantation</time_frame>
      <description>30-day readmission rates will be calculated using historical data (pre-intervention) and compared to rates once physical and occupational therapy consultation has been included in the inpatient admission order set for bone marrow transplantation (BMT).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The feasibility</measure>
      <time_frame>1 day (the date of bone marrow transplantation)</time_frame>
      <description>The proportion of individuals who received a physical and occupational therapy consultation in the prospective group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute care length of stay</measure>
      <time_frame>Up to 90 days after bone marrow transplantation</time_frame>
      <description>Acute care length of stay will be calculated using historical data (pre-intervention) and compared to rates once physical and occupational therapy consultation has been included in the inpatient admission order set for BMT.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality rates</measure>
      <time_frame>Up to 90 days after bone marrow transplantation</time_frame>
      <description>Mortality rates will be calculated by comparing, how many subjects died pre-intervention and post-intervention, using medical record data.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complication types and rates</measure>
      <time_frame>Up to 90 days after bone marrow transplantation</time_frame>
      <description>Complication types and rates will be calculated and compared pre-intervention and post-intervention using medical record data.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Bone Marrow Transplantation</condition>
    <condition>Bone Marrow Disease</condition>
    <arm_group>
      <arm_group_label>physical and occupational therapy</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Physical and occupational therapy consultation might be used to provide targeted prehabilitation interventions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>physical and occupational therapy consultation</intervention_name>
      <description>Physical and occupational therapy consultation during the inpatient admission period. This information may be used in the future to provide targeted prehabilitation interventions.</description>
      <arm_group_label>physical and occupational therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years at the time of admission for bone marrow transplantation (BMT)&#xD;
  &#xD;
            2. Received BMT&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. No history of inpatient admission for BMT&#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 Stephen, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UNC Lineberger Comprehensive Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sasha Knowlton</last_name>
      <phone>984 974 0293</phone>
      <email>sknow@email.unc.ed</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Stephen Rego</last_name>
      <email>stephen_rego@med.unc.edu</email>
    </overall_contact_backup>
    <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>
    </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>exercise</keyword>
    <keyword>physical therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bone Marrow Diseases</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/NCT05978583
  org study id: LCCC2252
  nct id: NCT05978583
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-site, non-randomized, interventional study designed to evaluate the impact
        of adding physical and occupational therapy consultation upon inpatient admission for a bone
        marrow transplantation (BMT). The purpose of this study is to investigate whether
        consultation with physical and occupational therapists as part of the general admission order
        set for patients scheduled for bone marrow transplant will result in reduced complications,
        morbidity, length of inpatient stay, 30-day readmission and 90-day mortality. Baseline data
        collection will be used to determine eligibility. This study will be partially retrospective
        (pre-implementation of physical and occupational therapy consultation order) and partially
        prospective.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: 30-day readmission
  time frame: Up to 30 days after bone marrow transplantation
  description: 30-day readmission rates will be calculated using historical data (pre-intervention) and compared to rates once physical and occupational therapy consultation has been included in the inpatient admission order set for bone marrow transplantation (BMT).
  measure: The feasibility
  time frame: 1 day (the date of bone marrow transplantation)
  description: The proportion of individuals who received a physical and occupational therapy consultation in the prospective group.
  measure: Acute care length of stay
  time frame: Up to 90 days after bone marrow transplantation
  description: Acute care length of stay will be calculated using historical data (pre-intervention) and compared to rates once physical and occupational therapy consultation has been included in the inpatient admission order set for BMT.
  measure: Mortality rates
  time frame: Up to 90 days after bone marrow transplantation
  description: Mortality rates will be calculated by comparing, how many subjects died pre-intervention and post-intervention, using medical record data.
  measure: Complication types and rates
  time frame: Up to 90 days after bone marrow transplantation
  description: Complication types and rates will be calculated and compared pre-intervention and post-intervention using medical record data.
  arm group label: physical and occupational therapy
  arm group type: Other
  description: Physical and occupational therapy consultation might be used to provide targeted prehabilitation interventions.
  intervention type: Other
  intervention name: physical and occupational therapy consultation
  description: Physical and occupational therapy consultation during the inpatient admission period. This information may be used in the future to provide targeted prehabilitation interventions.
  arm group label: physical and occupational therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sasha Stephen, MD
  role: Principal Investigator
  affiliation: UNC Lineberger Comprehensive Cancer Center
  last name: Sasha Knowlton
  phone: 984 974 0293
  email: sknow@email.unc.ed
  last name: Stephen Rego
  email: stephen_rego@med.unc.edu
  facility: 
  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: Bone Marrow Diseases
  sharing ipd: No