<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/NCT03042715</url>
  </required_header>
  <id_info>
    <org_study_id>16-522</org_study_id>
    <nct_id>NCT03042715</nct_id>
  </id_info>
  <brief_title>Psychological Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)</brief_title>
  <official_title>Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is evaluating a psychological intervention for caregivers of patients&#xD;
      undergoing stem cell transplantation.&#xD;
&#xD;
      Phase 1 will include a qualitative phase to refine the intervention to specifically target&#xD;
      the needs of caregivers&#xD;
&#xD;
      Phase 2 of the trial will transition to an interventional randomization clinical trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to find out whether a psychological intervention can help&#xD;
      caregivers learn effective coping methods during their loved one's transplant process and&#xD;
      make the experience of being a caregiver more manageable.&#xD;
&#xD;
      Phase 1 of the project entails using qualitative interviews with caregivers to further refine&#xD;
      the intervention. The psychological intervention will take place over the course of a patient&#xD;
      transplant in a series of eight sessions. A trained behavioral psychologist will meet with&#xD;
      the participant or talk with them over the telephone for 30-45 minutes at a time to discuss&#xD;
      the caregiver experience and to help develop effective skills to support the patient as well&#xD;
      as the participant over the course of the transplant.&#xD;
&#xD;
      Upon the completion of the sessions, the investigators will have a short, audio-recorded exit&#xD;
      interview to obtain the participant's feedback on the intervention. At the participant's&#xD;
      convenience, this interview will be conducted in-person or over the phone. The investigators&#xD;
      will use the feedback to improve the intervention before further testing its efficacy in&#xD;
      phase 2, a randomized clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pilot Qualitative Refinement of the Caregiver Intervention</measure>
    <time_frame>1 year</time_frame>
    <description>qualitative data to develop and refine the caregiver intervention</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">6</enrollment>
  <condition>Stem Cell Transplant Complications</condition>
  <arm_group>
    <arm_group_label>Psychological Intervention refinement</arm_group_label>
    <description>Eight weekly sessions in-person or via telephone&#xD;
Qualitative interviews&#xD;
Feedback from 5-10 caregivers to refine the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Qualitative Interviews</intervention_name>
    <description>phase 1 of the study entail refining the psychological intervention based on caregivers' feedback</description>
    <arm_group_label>Psychological Intervention refinement</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Caregivers will be recruited during the patient transplant consent visit, which typically&#xD;
        occurs 2-4 weeks prior to admission for HCT. Caregivers are required to attend the HCT&#xD;
        consent visit with the patient.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult caregivers (≥18 years) of patients undergoing HCT at MGH.&#xD;
&#xD;
          -  A relative or a friend who either lives with the patient or has in-person contact with&#xD;
             him or her at least twice per week and is identified as the primary caregiver for&#xD;
             transplant&#xD;
&#xD;
          -  Ability to speak English or able to complete questionnaires with minimum assistance of&#xD;
             an interpreter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder,&#xD;
             major depression)&#xD;
&#xD;
          -  Other co-morbid disease (dementia, cognitive impairment), which the treating clinician&#xD;
             believes prohibits the ability to participate in study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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</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 2021</verification_date>
  <study_first_submitted>January 28, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <results_first_submitted>August 29, 2018</results_first_submitted>
  <results_first_submitted_qc>December 1, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 18, 2019</results_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</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>Areej El-Jawahri, MD</investigator_title>
  </responsible_party>
  <keyword>Supportive Care</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 3, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03042715/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Qualitative Refinement</title>
          <description>this clinical trials.gov report is focused on the qualitative refinement phase of the project.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Psychological Intervention Refinement</title>
          <description>Eight weekly sessions in-person or via telephone&#xD;
Qualitative interviews&#xD;
Feedback from 5-10 caregivers to refine the intervention.&#xD;
Qualitative Interviews: phase 1 of the study entail refining the psychological intervention based on caregivers' feedback</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pilot Qualitative Refinement of the Caregiver Intervention</title>
        <description>qualitative data to develop and refine the caregiver intervention</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Qualitative Refinement</title>
            <description>pilot qualitative refinement of intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Pilot Qualitative Refinement of the Caregiver Intervention</title>
          <description>qualitative data to develop and refine the caregiver intervention</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>intervention length is feasible</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>session length is appropriate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>preferred fewer visits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>focus on mindfulness is appropriate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>qualitative refinement of an intervention, no adverse events reported during the entire study period (1 year). all caregivers were followed for a total of 3 months during the intervention refinement</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Qualitative Refinement</title>
          <description>this clinical trials.gov report is focused on the qualitative refinement phase of the project.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Areej El-Jawahri</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-724-4000</phone>
      <email>ael-jawahri@partners.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03042715
org study id: 16-522
nct id: NCT03042715
lead sponsor: 
has dmc: Yes
This research study is evaluating a psychological intervention for caregivers of patients
      undergoing stem cell transplantation.

      Phase 1 will include a qualitative phase to refine the intervention to specifically target
      the needs of caregivers

      Phase 2 of the trial will transition to an interventional randomization clinical trial
The purpose of this study is to find out whether a psychological intervention can help
      caregivers learn effective coping methods during their loved one's transplant process and
      make the experience of being a caregiver more manageable.

      Phase 1 of the project entails using qualitative interviews with caregivers to further refine
      the intervention. The psychological intervention will take place over the course of a patient
      transplant in a series of eight sessions. A trained behavioral psychologist will meet with
      the participant or talk with them over the telephone for 30-45 minutes at a time to discuss
      the caregiver experience and to help develop effective skills to support the patient as well
      as the participant over the course of the transplant.

      Upon the completion of the sessions, the investigators will have a short, audio-recorded exit
      interview to obtain the participant's feedback on the intervention. At the participant's
      convenience, this interview will be conducted in-person or over the phone. The investigators
      will use the feedback to improve the intervention before further testing its efficacy in
      phase 2, a randomized clinical trial.
observational model: Cohort
time perspective: Prospective
measure: Pilot Qualitative Refinement of the Caregiver Intervention
time frame: 1 year
description: qualitative data to develop and refine the caregiver intervention
arm group label: Psychological Intervention refinement
description: Eight weekly sessions in-person or via telephone
Qualitative interviews
Feedback from 5-10 caregivers to refine the intervention.
intervention type: Behavioral
intervention name: Qualitative Interviews
description: phase 1 of the study entail refining the psychological intervention based on caregivers' feedback
arm group label: Psychological Intervention refinement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
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: Areej El-Jawahri, MD
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 