<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/NCT04479995</url>
  </required_header>
  <id_info>
    <org_study_id>19-772</org_study_id>
    <nct_id>NCT04479995</nct_id>
  </id_info>
  <brief_title>Multidisciplinary Intervention In Chronic GVHD</brief_title>
  <official_title>Multidisciplinary Intervention to Promote Medical Adherence and Coping in Patients With Moderate to Severe Chronic Graft-Versus-Host Disease (GVHD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</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 is being done to evaluate the feasibility and efficacy of a multidisciplinary,&#xD;
      patient-centered intervention, Horizons Program, versus minimally enhanced standard care to&#xD;
      improve quality of life, symptom burden and psychological distress of adults who received an&#xD;
      allogeneic hematopoietic stem cell transplant and developed graft versus-host disease (GVHD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized research study is being conducted to see if the Horizons Program compared to&#xD;
      usual care is manageable and effective at improving understanding of chronic GVHD and&#xD;
      treatment, coping, and quality of life.&#xD;
&#xD;
      Randomization means that participants will be put into one of two groups by chance:&#xD;
&#xD;
        -  Horizons Program&#xD;
&#xD;
           --Individuals who receive the Horizons Program will attend 8 weekly 90-minute group&#xD;
           sessions using a secure TeleHealth videoconferencing system&#xD;
&#xD;
        -  Usual care --Individuals who receive usual care will also receive an educational&#xD;
           booklet.&#xD;
&#xD;
      The research study procedures include:&#xD;
&#xD;
        -  screening for eligibility&#xD;
&#xD;
        -  a brief test of videoconferencing software&#xD;
&#xD;
        -  completion of three study assessments (after signing consent but before randomization&#xD;
           and at 8 weeks and 16 weeks after the start of the Horizons Program)&#xD;
&#xD;
        -  Individuals who receive usual care will also receive an educational booklet. It is&#xD;
           anticipated 80 people will take part in this research study.&#xD;
&#xD;
      The MGH BMT Survivorship Program is supporting this research study by providing funding for&#xD;
      this project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 2, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2023</completion_date>
  <primary_completion_date type="Actual">April 1, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Enrollment</measure>
    <time_frame>Baseline (pre-randomization) to 8 week follow up</time_frame>
    <description>Feasibility will be demonstrated if ≥50% eligible participants enroll</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of adherence</measure>
    <time_frame>Baseline (pre-randomization) to 8 week follow up</time_frame>
    <description>Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of retention</measure>
    <time_frame>Baseline (pre-randomization) to 8 week follow up</time_frame>
    <description>Feasibility will be demonstrated if 80% of participants remain in study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL): Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)</measure>
    <time_frame>Baseline (pre-randomization) up to 16 week follow up</time_frame>
    <description>We will use linear mixed models to investigate longitudinal differences in quality of life between study groups (FACT-BMT score range 0-164, with higher scores indicating better quality of life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Burden: Lee Chronic Graft-Versus-Host Disease Symptom Scale (Lee cGVHD)</measure>
    <time_frame>Baseline (pre-randomization) up to 16 week follow up</time_frame>
    <description>We will use linear mixed models to investigate longitudinal differences in symptom burden between study groups (Lee cGVHD score range 0-56, with higher scores indicating worse symptom burden).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Distress: Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Baseline (pre-randomization) up to 16 week follow up</time_frame>
    <description>We will use linear mixed models to investigate longitudinal differences in psychological distress between study groups (HADS score range 0-21, with higher scores indicating greater distress).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Adherence: Medication Adherence Report Scale (MARS-5)</measure>
    <time_frame>Baseline (pre-randomization) up to 16 week follow up</time_frame>
    <description>We will use linear mixed models to investigate longitudinal differences in medical adherence self management between study groups (MARS-5 score range 5-25, with higher scores indicating greater adherence).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Support: Medical Outcomes Study Social Support Survey (MOS SSS)</measure>
    <time_frame>Baseline (pre-randomization) up to 16 week follow up</time_frame>
    <description>We will use linear mixed models to investigate longitudinal differences in social support self management between study groups (MOS SSS score range 0-100, with higher scores indicating greater support).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy: Cancer Self-Efficacy Scale (CASE)</measure>
    <time_frame>Baseline (pre-randomization) up to 16 week follow up</time_frame>
    <description>We will use linear mixed models to investigate longitudinal differences in cancer self-efficacy between study groups (CASE score range 0-170, with higher scores indicating greater self-efficacy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping Skills: Measure of Current Status (MOCS)</measure>
    <time_frame>Baseline (pre-randomization) up to 16 week follow up</time_frame>
    <description>Using to compare Coping Skills self management target between study groups&#xD;
We will use linear mixed models to investigate longitudinal differences in coping skills between study groups (CASE score range 0-52, with higher scores indicating greater coping skill).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Stem Cell Transplant Complications</condition>
  <condition>Graft Vs Host Disease</condition>
  <condition>Coping Skills</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Horizon Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eight weekly, audio recorded telehealth videoconferencing sessions. Sessions are 90 minutes.&#xD;
Questionnaire assessments at 8 and 16 weeks after end of videoconferencing sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard medical visits to address chronic GVHD, with an additional standardized booklet, in electronic or paper format, containing information on the management of chronic GVHD and stem cell transplant survivorship recommendations.&#xD;
Questionnaire assessment at 8 weeks and 16 weeks after Horizons Program group starts</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Horizon Program</intervention_name>
    <description>Telehealth videoconferencing sessions and questionnaires.</description>
    <arm_group_label>Horizon Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Standard medical visits with additional paper or electronic booklet.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients (≥ 21 years) who underwent allogeneic HCT&#xD;
&#xD;
          -  have moderate to severe chronic GVHD&#xD;
&#xD;
          -  are currently receiving their care at the MGH Blood and Marrow Transplant Clinic&#xD;
&#xD;
          -  have the ability to participate in an English language group intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with comorbid conditions or cognitive impairment that the treating clinician&#xD;
             believes prohibits informed consent or participation in the intervention&#xD;
&#xD;
          -  Vulnerable patients, defined here as prisoners and pregnant women, will not be&#xD;
             included in the intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Areej El-Jawahri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>El-Jawahri, Areej,M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Stem Cell Transplant Complications</keyword>
  <keyword>Graft Vs Host Disease</keyword>
  <keyword>Coping Skills</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Graft vs Host Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
    <ipd_access_criteria>Contact the Partners Innovations team at http://www.partners.org/innovation</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04479995
org study id: 19-772
nct id: NCT04479995
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research is being done to evaluate the feasibility and efficacy of a multidisciplinary,
      patient-centered intervention, Horizons Program, versus minimally enhanced standard care to
      improve quality of life, symptom burden and psychological distress of adults who received an
      allogeneic hematopoietic stem cell transplant and developed graft versus-host disease (GVHD).
This randomized research study is being conducted to see if the Horizons Program compared to
      usual care is manageable and effective at improving understanding of chronic GVHD and
      treatment, coping, and quality of life.

      Randomization means that participants will be put into one of two groups by chance:

        -  Horizons Program

           --Individuals who receive the Horizons Program will attend 8 weekly 90-minute group
           sessions using a secure TeleHealth videoconferencing system

        -  Usual care --Individuals who receive usual care will also receive an educational
           booklet.

      The research study procedures include:

        -  screening for eligibility

        -  a brief test of videoconferencing software

        -  completion of three study assessments (after signing consent but before randomization
           and at 8 weeks and 16 weeks after the start of the Horizons Program)

        -  Individuals who receive usual care will also receive an educational booklet. It is
           anticipated 80 people will take part in this research study.

      The MGH BMT Survivorship Program is supporting this research study by providing funding for
      this project.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of Enrollment
time frame: Baseline (pre-randomization) to 8 week follow up
description: Feasibility will be demonstrated if ≥50% eligible participants enroll
measure: Rate of adherence
time frame: Baseline (pre-randomization) to 8 week follow up
description: Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions
measure: Rate of retention
time frame: Baseline (pre-randomization) to 8 week follow up
description: Feasibility will be demonstrated if 80% of participants remain in study
measure: Quality of life (QOL): Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
time frame: Baseline (pre-randomization) up to 16 week follow up
description: We will use linear mixed models to investigate longitudinal differences in quality of life between study groups (FACT-BMT score range 0-164, with higher scores indicating better quality of life).
measure: Symptom Burden: Lee Chronic Graft-Versus-Host Disease Symptom Scale (Lee cGVHD)
time frame: Baseline (pre-randomization) up to 16 week follow up
description: We will use linear mixed models to investigate longitudinal differences in symptom burden between study groups (Lee cGVHD score range 0-56, with higher scores indicating worse symptom burden).
measure: Psychological Distress: Hospital Anxiety and Depression Scale (HADS)
time frame: Baseline (pre-randomization) up to 16 week follow up
description: We will use linear mixed models to investigate longitudinal differences in psychological distress between study groups (HADS score range 0-21, with higher scores indicating greater distress).
measure: Medical Adherence: Medication Adherence Report Scale (MARS-5)
time frame: Baseline (pre-randomization) up to 16 week follow up
description: We will use linear mixed models to investigate longitudinal differences in medical adherence self management between study groups (MARS-5 score range 5-25, with higher scores indicating greater adherence).
measure: Social Support: Medical Outcomes Study Social Support Survey (MOS SSS)
time frame: Baseline (pre-randomization) up to 16 week follow up
description: We will use linear mixed models to investigate longitudinal differences in social support self management between study groups (MOS SSS score range 0-100, with higher scores indicating greater support).
measure: Self-Efficacy: Cancer Self-Efficacy Scale (CASE)
time frame: Baseline (pre-randomization) up to 16 week follow up
description: We will use linear mixed models to investigate longitudinal differences in cancer self-efficacy between study groups (CASE score range 0-170, with higher scores indicating greater self-efficacy).
measure: Coping Skills: Measure of Current Status (MOCS)
time frame: Baseline (pre-randomization) up to 16 week follow up
description: Using to compare Coping Skills self management target between study groups
We will use linear mixed models to investigate longitudinal differences in coping skills between study groups (CASE score range 0-52, with higher scores indicating greater coping skill).
arm group label: Horizon Program
arm group type: Experimental
description: Eight weekly, audio recorded telehealth videoconferencing sessions. Sessions are 90 minutes.
Questionnaire assessments at 8 and 16 weeks after end of videoconferencing sessions
arm group label: Usual Care
arm group type: Experimental
description: Standard medical visits to address chronic GVHD, with an additional standardized booklet, in electronic or paper format, containing information on the management of chronic GVHD and stem cell transplant survivorship recommendations.
Questionnaire assessment at 8 weeks and 16 weeks after Horizons Program group starts
intervention type: Behavioral
intervention name: Horizon Program
description: Telehealth videoconferencing sessions and questionnaires.
arm group label: Horizon Program
intervention type: Behavioral
intervention name: Usual Care
description: Standard medical visits with additional paper or electronic booklet.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Areej El-Jawahri, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: El-Jawahri, Areej,M.D.
investigator title: Principal Investigator
mesh term: Graft vs Host Disease
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication
ipd access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation