<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/NCT01725022</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00032263</org_study_id>
    <nct_id>NCT01725022</nct_id>
  </id_info>
  <brief_title>A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care</brief_title>
  <official_title>A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal with this study is to document whether patients can maintain their normal&#xD;
      bowel microbiota by staying at home compared to those who live at home but are treated in&#xD;
      clinic, and those who are treated in the hospital. In addition, the investigators would&#xD;
      predict that the quality of life will be higher for those patients treated at the medical&#xD;
      home compared to those that stay at the hospital. The investigators also predict that the&#xD;
      costs associated with this approach will be significantly lower compared to hospitalized&#xD;
      patients. Finally, the investigators propose that the treatment related morbidities and&#xD;
      mortality will not be different between the two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects enrolled in the medical home arm and those serving as concurrent controls will have&#xD;
      the following studies:&#xD;
&#xD;
        1. Stool collection for analysis at time 0 (prior to preparatory regimen) and then weekly&#xD;
           for the first four weeks, at day 60 and 100.&#xD;
&#xD;
        2. The PG-SGA, FACT-BMT and other patient-reported symptom instruments will be collected&#xD;
           weekly for the first 4 weeks, at day 60, 100 and patients will be required to complete a&#xD;
           daily food diary.&#xD;
&#xD;
        3. Other assessments for toxicities or GVHD will proceed as per current standard of care,&#xD;
           for a total blood draw amount of 100 mls from home care subjects and concurrent&#xD;
           controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bowel Microbiota</measure>
    <time_frame>100 days</time_frame>
    <description>The bowel microbiota before and during the first 100 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nutritional status using the PG-SGA assessment tool</measure>
    <time_frame>100 days</time_frame>
    <description>The assessment tool to capture overall nutritional status will be the Patient Generated Subjective Global Assessment (PG-SGA) which has been validated in other cancer patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of acute Graft Versus Host Disease (GVHD)</measure>
    <time_frame>100 days</time_frame>
    <description>All incidences of Grade II-IV GVHD will be quantified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment related morbidities and mortalities</measure>
    <time_frame>100 Days</time_frame>
    <description>Both treatment related morbidities and mortalities will be quantified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality Of Life Assessment (QOL)</measure>
    <time_frame>100 Days</time_frame>
    <description>The QOL assessment will utilize the FACT-BMT (Functional Assessment of Cancer Therapy Bone Marrow Transplant) assessment tool as well as other patient-reported symptom instruments to capture the patient reported experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs of care</measure>
    <time_frame>100 Days</time_frame>
    <description>The mean, median and range of costs will be compared in the three arms.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Hematologic Malignancies</condition>
  <arm_group>
    <arm_group_label>Home Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the arm for patients who receive their transplant care in their homes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hospital Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care for stem cell transplant recipients where the aftercare is done in hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinic Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Care</intervention_name>
    <description>This is the interventional arm where patients receive the transplant care in their homes.</description>
    <arm_group_label>Home Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Scheduled to undergo a hematopoietic stem cell transplant for any cancer or non-cancer&#xD;
             illness from any autologous, related or unrelated donor source including bone marrow,&#xD;
             peripheral blood progenitor cell, or umbilical cord blood&#xD;
&#xD;
          2. Age 18-80 years of age&#xD;
&#xD;
          3. Karnofsky Performance Scale (KPS) &gt; 80&#xD;
&#xD;
          4. A home that is deemed, upon inspection, in suitable condition to serve as a medical&#xD;
             home, within a 90-minute driving distance of Duke (home care group only)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lack of a caregiver&#xD;
&#xD;
          2. Pregnant women (It is standard of care to assess for pregnancy for all females of&#xD;
             child-bearing potential with a serum beta human chorionic gonadotropin (HCG) test&#xD;
             within 7 days of starting the preparative regimen prior to transplant. No additional&#xD;
             research pregnancy testing will occur.)&#xD;
&#xD;
          3. Patients with a documented active infection prior to starting their preparative&#xD;
             regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nelson Chao, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stem cell transplant</keyword>
  <keyword>bowel microbiota</keyword>
  <keyword>home care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01725022
org study id: Pro00032263
nct id: NCT01725022
lead sponsor: 
has dmc: Yes
The primary goal with this study is to document whether patients can maintain their normal
      bowel microbiota by staying at home compared to those who live at home but are treated in
      clinic, and those who are treated in the hospital. In addition, the investigators would
      predict that the quality of life will be higher for those patients treated at the medical
      home compared to those that stay at the hospital. The investigators also predict that the
      costs associated with this approach will be significantly lower compared to hospitalized
      patients. Finally, the investigators propose that the treatment related morbidities and
      mortality will not be different between the two groups.
Subjects enrolled in the medical home arm and those serving as concurrent controls will have
      the following studies:

        1. Stool collection for analysis at time 0 (prior to preparatory regimen) and then weekly
           for the first four weeks, at day 60 and 100.

        2. The PG-SGA, FACT-BMT and other patient-reported symptom instruments will be collected
           weekly for the first 4 weeks, at day 60, 100 and patients will be required to complete a
           daily food diary.

        3. Other assessments for toxicities or GVHD will proceed as per current standard of care,
           for a total blood draw amount of 100 mls from home care subjects and concurrent
           controls.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Bowel Microbiota
time frame: 100 days
description: The bowel microbiota before and during the first 100 days.
measure: Nutritional status using the PG-SGA assessment tool
time frame: 100 days
description: The assessment tool to capture overall nutritional status will be the Patient Generated Subjective Global Assessment (PG-SGA) which has been validated in other cancer patients.
measure: Incidence of acute Graft Versus Host Disease (GVHD)
time frame: 100 days
description: All incidences of Grade II-IV GVHD will be quantified.
measure: Treatment related morbidities and mortalities
time frame: 100 Days
description: Both treatment related morbidities and mortalities will be quantified.
measure: Quality Of Life Assessment (QOL)
time frame: 100 Days
description: The QOL assessment will utilize the FACT-BMT (Functional Assessment of Cancer Therapy Bone Marrow Transplant) assessment tool as well as other patient-reported symptom instruments to capture the patient reported experience.
measure: Costs of care
time frame: 100 Days
description: The mean, median and range of costs will be compared in the three arms.
arm group label: Home Care
arm group type: Experimental
description: This is the arm for patients who receive their transplant care in their homes.
arm group label: Hospital Care
arm group type: No Intervention
description: Standard of care for stem cell transplant recipients where the aftercare is done in hospital.
arm group label: Clinic Care
arm group type: No Intervention
description: Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic.
intervention type: Other
intervention name: Home Care
description: This is the interventional arm where patients receive the transplant care in their homes.
arm group label: Home Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nelson Chao, MD, MBA
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hematologic Neoplasms