<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/NCT03244826</url>
  </required_header>
  <id_info>
    <org_study_id>17-253</org_study_id>
    <nct_id>NCT03244826</nct_id>
  </id_info>
  <brief_title>Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation</brief_title>
  <official_title>Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dana-Farber Cancer Institute</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 research study aims to evaluate the effectiveness of allowing patients who have had a&#xD;
      hematopoietic cell transplant to receive some of their post-transplant care with a local&#xD;
      oncologist rather than returning to the transplant center for all of their follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hematopoietic Cell Transplantation (HCT) - also known as bone marrow transplant - is only&#xD;
      available at select centers in the United States which can collect and store stem cells, as&#xD;
      well as care for patients before their new immune system cells take hold. For this reason,&#xD;
      many patients who undergo HCT live at great distances from their HCT center. Also, after&#xD;
      hospital discharge, the first 180 days post-HCT are very important, as patients must be&#xD;
      managed closely with frequent follow-up visits.&#xD;
&#xD;
      A potential way to make life easier for HCT patients is to allow some of the post-transplant&#xD;
      care to be provided by local oncologists who practice closer to where patients live. This&#xD;
      could reduce the burden on patients and their caregivers; however, it is not known if a&#xD;
      shared care model would ultimately benefit them. The investigators want to assess the&#xD;
      effectiveness of a Shared Care program which allows patients to receive half of their&#xD;
      post-HCT care at the HCT center, and the other half with their local oncologist&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">August 22, 2022</completion_date>
  <primary_completion_date type="Actual">August 22, 2022</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Highly-relevant PROs for Shared versus Usual Care at 180 days post-HCT</measure>
    <time_frame>180 days</time_frame>
    <description>Fact-BMT (standard measure of transplant-related quality of life)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Highly-relevant PROs for Shared versus Usual Care at 180 days post-HCT</measure>
    <time_frame>180 days</time_frame>
    <description>EORTC QLQ-C30 (standard measure of cancer-related quality of life)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Highly-relevant PROs for Shared versus Usual Care at 180 days post-HCT</measure>
    <time_frame>180 days</time_frame>
    <description>Dana-Farber post-transplant Survey (questionnaire developed to measure financial hardship after transplant; See Abel, et al BBMT, 2016)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>100-day non-relapse mortality (NRM) for patients in Shared Care versus Usual Care</measure>
    <time_frame>100 days</time_frame>
    <description>NRM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>2 years</time_frame>
    <description>OS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cGVHD</measure>
    <time_frame>2 years</time_frame>
    <description>cGVHD</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">404</enrollment>
  <condition>Other Cancer</condition>
  <arm_group>
    <arm_group_label>Shared Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the first 90 days, patients alternate between local oncologist and DFCI for weekly visits.&#xD;
From 90 to 180 days, patients alternate between local and DFCI every 2-3 weeks.&#xD;
Shared Care include the following&#xD;
Formal Care Coordination Plan&#xD;
Patient Engagement and Education&#xD;
Local Oncologist Engagement and Education&#xD;
Patient/Local Oncologist/Transplant Oncologist Web Portal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients receive all follow-up care at DFCI only, which is currently the Standard Care.&#xD;
Majority of routine visits in first 180 days will be at DFCI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Randomized</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients receive all follow-up care at DFCI only (Standard Care).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shared Care</intervention_name>
    <description>Shared Care involves four specific strategies to allow patients to have a portion of their care locally after HCT, where clinic and laboratory visits are equally shared between the local oncologist and primary HCT team</description>
    <arm_group_label>Shared Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>The usual care provided by the transplant center at DFCI.</description>
    <arm_group_label>Non-Randomized</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18 years of age&#xD;
&#xD;
          -  Scheduled to receive an allogeneic HCT at the Dana-Farber Inpatient Hospital or BWH&#xD;
             under the care of a DFCI physician&#xD;
&#xD;
          -  Residence in New York, Maine, New Hampshire, Vermont, Connecticut, or Massachusetts&#xD;
&#xD;
          -  Referred from or live less than 1 hour from one of the local participating centers.&#xD;
&#xD;
          -  Ability to read English (to fill out standard QOL forms)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years of age&#xD;
&#xD;
          -  Scheduled to receive an autologous HCT&#xD;
&#xD;
          -  Has received an allogeneic transplant in the past; scheduled to receive a second&#xD;
             allogeneic transplant&#xD;
&#xD;
          -  Did not receive an allogeneic HCT at Dana-Farber&#xD;
&#xD;
          -  Does not live in New York, Maine, New Hampshire, Vermont, Connecticut, or&#xD;
             Massachusetts&#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>Gregory A. Abel, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stamford Hospital</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Light Cancer Center dba Eastern Maine Medical Center</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Cancer Specialists</name>
      <address>
        <city>Brunswick</city>
        <state>Maine</state>
        <zip>04011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber at Milford</name>
      <address>
        <city>Milford</city>
        <state>Massachusetts</state>
        <zip>01757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber at South Shore Hospital</name>
      <address>
        <city>Weymouth</city>
        <state>Massachusetts</state>
        <zip>02190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber at Londonderry</name>
      <address>
        <city>Londonderry</city>
        <state>New Hampshire</state>
        <zip>03053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Oncology Hematology</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lifespan Cancer Institute at Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Gregory A. Abel, MD</investigator_full_name>
    <investigator_title>Gregory A. Abel. MD, MPH</investigator_title>
  </responsible_party>
  <keyword>Cancer</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 18, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03244826
org study id: 17-253
nct id: NCT03244826
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research study aims to evaluate the effectiveness of allowing patients who have had a
      hematopoietic cell transplant to receive some of their post-transplant care with a local
      oncologist rather than returning to the transplant center for all of their follow-up.
Hematopoietic Cell Transplantation (HCT) - also known as bone marrow transplant - is only
      available at select centers in the United States which can collect and store stem cells, as
      well as care for patients before their new immune system cells take hold. For this reason,
      many patients who undergo HCT live at great distances from their HCT center. Also, after
      hospital discharge, the first 180 days post-HCT are very important, as patients must be
      managed closely with frequent follow-up visits.

      A potential way to make life easier for HCT patients is to allow some of the post-transplant
      care to be provided by local oncologists who practice closer to where patients live. This
      could reduce the burden on patients and their caregivers; however, it is not known if a
      shared care model would ultimately benefit them. The investigators want to assess the
      effectiveness of a Shared Care program which allows patients to receive half of their
      post-HCT care at the HCT center, and the other half with their local oncologist
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Highly-relevant PROs for Shared versus Usual Care at 180 days post-HCT
time frame: 180 days
description: Fact-BMT (standard measure of transplant-related quality of life)
measure: Highly-relevant PROs for Shared versus Usual Care at 180 days post-HCT
time frame: 180 days
description: EORTC QLQ-C30 (standard measure of cancer-related quality of life)
measure: Highly-relevant PROs for Shared versus Usual Care at 180 days post-HCT
time frame: 180 days
description: Dana-Farber post-transplant Survey (questionnaire developed to measure financial hardship after transplant; See Abel, et al BBMT, 2016)
measure: 100-day non-relapse mortality (NRM) for patients in Shared Care versus Usual Care
time frame: 100 days
description: NRM
measure: Overall Survival
time frame: 2 years
description: OS
measure: cGVHD
time frame: 2 years
description: cGVHD
arm group label: Shared Care
arm group type: Experimental
description: For the first 90 days, patients alternate between local oncologist and DFCI for weekly visits.
From 90 to 180 days, patients alternate between local and DFCI every 2-3 weeks.
Shared Care include the following
Formal Care Coordination Plan
Patient Engagement and Education
Local Oncologist Engagement and Education
Patient/Local Oncologist/Transplant Oncologist Web Portal
arm group label: Usual Care
arm group type: Other
description: Patients receive all follow-up care at DFCI only, which is currently the Standard Care.
Majority of routine visits in first 180 days will be at DFCI.
arm group label: Non-Randomized
arm group type: Other
description: Patients receive all follow-up care at DFCI only (Standard Care).
intervention type: Other
intervention name: Shared Care
description: Shared Care involves four specific strategies to allow patients to have a portion of their care locally after HCT, where clinic and laboratory visits are equally shared between the local oncologist and primary HCT team
arm group label: Shared Care
intervention type: Other
intervention name: Standard Care
description: The usual care provided by the transplant center at DFCI.
arm group label: Non-Randomized
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gregory A. Abel, MD MPH
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Gregory A. Abel, MD
investigator title: Gregory A. Abel. MD, MPH
sharing ipd: No
submitted: August 18, 2023