<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/NCT03758911</url>
  </required_header>
  <id_info>
    <org_study_id>J16127</org_study_id>
    <secondary_id>IRB00111131</secondary_id>
    <secondary_id>2016-03p</secondary_id>
    <nct_id>NCT03758911</nct_id>
  </id_info>
  <brief_title>Perspectives on Bone Marrow Donors Who Donate for Their Parent</brief_title>
  <official_title>Perspectives on the Adolescent, Young Adult, and Adult Experience as Donors for Their Parent Undergoing Haploidentical Bone Marrow Transplants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</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>
      The purpose of this pilot study is to explore the role of family function on decision-making&#xD;
      for bone marrow donors who donated for their parent, and to assess the unique supportive care&#xD;
      needs of these participants. Semi-structured interviews were conducted with participants to&#xD;
      identify overarching themes of the donation experience.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2016</start_date>
  <completion_date type="Actual">June 29, 2017</completion_date>
  <primary_completion_date type="Actual">June 29, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Themes influencing donors' decision-making as assessed by words used during interview responses</measure>
    <time_frame>Day 1</time_frame>
    <description>Words/terms are extracted from interviewer responses and associated to key themes that influence participant's decision-making process. A codebook is used to reference these words/terms</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Bone Marrow Transplant</condition>
  <arm_group>
    <arm_group_label>bone marrow/blood stem cell donors</arm_group_label>
    <description>Participants underwent a one time semi-structured telephone interview to understand the perspectives of bone marrow/stem cell donors experience, including how family dynamics impacted participants' decision to donate and identifying unique supportive care needs of bone marrow/stem cell donors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Semi-structured Interview</intervention_name>
    <arm_group_label>bone marrow/blood stem cell donors</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants included adolescents, young adults, or adults who had donated bone marrow or&#xD;
        peripheral blood stem cells for their parent in the past 1 - 6 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Donated bone marrow or peripheral blood stem cells for their parent in the past 1-6&#xD;
             months&#xD;
&#xD;
          -  Willing to participate in mandatory audio recorded telephone interview&#xD;
&#xD;
          -  Able to participate in interview without assistance&#xD;
&#xD;
          -  Must be English speaking&#xD;
&#xD;
          -  Transplant recipient (parent) must be living&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide oral consent for participation (for minors- unable to obtain&#xD;
             parental consent and/or oral assent from child for participation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nina D Wagner-Johnston, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bone marrow</keyword>
  <keyword>stem cell</keyword>
  <keyword>donor</keyword>
  <keyword>interview</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03758911
org study id: J16127
secondary id: IRB00111131
secondary id: 2016-03p
nct id: NCT03758911
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot study is to explore the role of family function on decision-making
      for bone marrow donors who donated for their parent, and to assess the unique supportive care
      needs of these participants. Semi-structured interviews were conducted with participants to
      identify overarching themes of the donation experience.
observational model: Case-Only
time perspective: Prospective
measure: Themes influencing donors' decision-making as assessed by words used during interview responses
time frame: Day 1
description: Words/terms are extracted from interviewer responses and associated to key themes that influence participant's decision-making process. A codebook is used to reference these words/terms
arm group label: bone marrow/blood stem cell donors
description: Participants underwent a one time semi-structured telephone interview to understand the perspectives of bone marrow/stem cell donors experience, including how family dynamics impacted participants' decision to donate and identifying unique supportive care needs of bone marrow/stem cell donors.
intervention type: Other
intervention name: Semi-structured Interview
arm group label: bone marrow/blood stem cell donors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nina D Wagner-Johnston, MD
role: Principal Investigator
affiliation: Johns Hopkins University
responsible party type: Sponsor
sharing ipd: Undecided