<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/NCT02199548</url>
  </required_header>
  <id_info>
    <org_study_id>GPS14</org_study_id>
    <nct_id>NCT02199548</nct_id>
  </id_info>
  <brief_title>The Good Patient Study</brief_title>
  <official_title>The Good Patient Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Jude Children's Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adolescents with cancer weigh multiple influences in medical decision-making, including their&#xD;
      own best interest, the perceived wishes of family members, and the interpreted preferences of&#xD;
      the health care team. Parents of children with cancer often describe themselves as trying to&#xD;
      be a good parent in making decisions in the child's best interest. Adolescents with cancer&#xD;
      often describe themselves as trying to be a good patient and good child in making decisions&#xD;
      in accord with how they believe a good patient and good child would decide.&#xD;
&#xD;
      Among the challenges of caring for adolescents is the reality that the formative relational&#xD;
      influences in adolescents' decision-making are both complex and unique due to adolescent&#xD;
      patients' social networks and relational roles. Delineating adolescents' definitions of being&#xD;
      a good patient, a good child, a good sibling, and a good friend may enable the care team to&#xD;
      better understand the formative decisional influences relevant to adolescents with cancer.&#xD;
      Expanding knowledge about the decision making constructs relevant to adolescents with cancer&#xD;
      and recognizing the role of these social constructs in medical interactions has the potential&#xD;
      for development of a comprehensive care model that methodically evaluates the self-assessed&#xD;
      decision making influences and needs of adolescents at various stages in oncology care.&#xD;
&#xD;
      This qualitative construct-defining study represents an initial step in the development of&#xD;
      enhanced interventions for improved psychosocial support in this vulnerable population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
        -  Describe the ways relationships and social interactions may factor into adolescent study&#xD;
           participants' approach to decisions;&#xD;
&#xD;
        -  By reports from adolescents with cancer, identify behaviors from members of the study&#xD;
           participants' social network that would be helpful to adolescents in fulfilling their&#xD;
           preferred role in medical decision-making and achieving the desired level of&#xD;
           participation in medical decision-making;&#xD;
&#xD;
        -  Identify adolescent participants' preferred role in medical decision making.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
        -  Develop definitions of being a &quot;good&quot; patient, child, sibling, and friend from&#xD;
           adolescent participant reports (will also welcome the study participant to self-declare&#xD;
           any additional relational constructs they may wish to report);&#xD;
&#xD;
        -  Describe how the adolescent study participant believes his or her &quot;good&quot; patient, child,&#xD;
           sibling, and friend definition may have changed over time;&#xD;
&#xD;
        -  Describe the self-assessed positive and negative aspects of trying to achieve the&#xD;
           meanings of the &quot;good&quot; patient, child, sibling, and friend constructs from adolescent&#xD;
           participant reports;&#xD;
&#xD;
        -  Describe the actions of members of the study participant's social network which may help&#xD;
           the study participant reach his/her definition of being a &quot;good&quot; patient, child,&#xD;
           sibling, and friend.&#xD;
&#xD;
      Participants will participate in a one-time voice-recorded, face-to-face interview consisting&#xD;
      of open-ended questions. Completion of the interview is expected to take less than one hour.&#xD;
&#xD;
      The qualitative interview consists of thirty open-ended questions for participants with no&#xD;
      siblings and thirty-eight open-ended questions for participants who have siblings. Questions&#xD;
      will be audio-recorded, face-to-face semi-structured in-depth interview format. Health&#xD;
      information will also be collected from medical records.&#xD;
&#xD;
      Expected accrual is 100 participants, 50 at each participating site. Accrual will be halted&#xD;
      when the study reaches qualitative theme saturation. For this study, saturation will occur&#xD;
      when three consecutive interviews fail to raise a new theme.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Factors contributing to decision-making</measure>
    <time_frame>Once, at enrollment</time_frame>
    <description>Describe the ways relationships and social interactions may factor into adolescent study participants' approach to decisions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behaviors that make a positive impact on decision-making</measure>
    <time_frame>Once, at enrollment</time_frame>
    <description>By reports from adolescents with cancer, identify behaviors from members of the study participants' social network that would be helpful to adolescents in fulfilling their preferred role in medical decision-making and achieving the desired level of participation in medical decision-making.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preferred decision-making role</measure>
    <time_frame>Once, at enrollment</time_frame>
    <description>Identify adolescent participants' preferred role in medical decision making.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Solid Tumor</condition>
  <condition>Hematological Malignancies</condition>
  <condition>Brain Tumor</condition>
  <arm_group>
    <arm_group_label>Study Participants</arm_group_label>
    <description>All enrolled participants will take part in a face-to-face interview.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>This study involves teen participants taking part in one private interview with the study team. Interviews last less than one hour and are scheduled at the participant's convenience. Interviews will be audio/digital recorded. Participants may answer any or all of the questions.</description>
    <arm_group_label>Study Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be teens who are patients at St. Jude Children's Research Hospital and&#xD;
        meet the criteria for study enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be between 12 and 19 years of age at the time of enrollment.&#xD;
&#xD;
          -  Participants must have primary care team approval to participate.&#xD;
&#xD;
          -  Participants must be English-speaking.&#xD;
&#xD;
          -  Participants must carry an oncologic diagnosis.&#xD;
&#xD;
          -  Participants must be within four months of initial oncologic diagnosis or within four&#xD;
             months of relapse/recurrent disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  This study lacks any exclusion related to pregnancy (an Institutional Review Board&#xD;
             requirement for enrollment of females who are capable of becoming pregnant), lactation&#xD;
             or plans to become pregnant and lacks any exclusion of males fathering children while&#xD;
             on study.&#xD;
&#xD;
          -  Patients who, in the opinion of their physician, are not capable mentally or verbally&#xD;
             of participating in the interview, will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meaghann Weaver, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's National Health System</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.stjude.org</url>
    <description>St. Jude Children's Research Hospital</description>
  </link>
  <link>
    <url>http://www.stjude.org/protocols</url>
    <description>Clinical Trials Open at St. Jude</description>
  </link>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>June 3, 2015</last_update_submitted>
  <last_update_submitted_qc>June 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent</keyword>
  <keyword>Decision-making</keyword>
  <keyword>Social network</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/NCT02199548
org study id: GPS14
nct id: NCT02199548
lead sponsor: 
has dmc: No
Adolescents with cancer weigh multiple influences in medical decision-making, including their
      own best interest, the perceived wishes of family members, and the interpreted preferences of
      the health care team. Parents of children with cancer often describe themselves as trying to
      be a good parent in making decisions in the child's best interest. Adolescents with cancer
      often describe themselves as trying to be a good patient and good child in making decisions
      in accord with how they believe a good patient and good child would decide.

      Among the challenges of caring for adolescents is the reality that the formative relational
      influences in adolescents' decision-making are both complex and unique due to adolescent
      patients' social networks and relational roles. Delineating adolescents' definitions of being
      a good patient, a good child, a good sibling, and a good friend may enable the care team to
      better understand the formative decisional influences relevant to adolescents with cancer.
      Expanding knowledge about the decision making constructs relevant to adolescents with cancer
      and recognizing the role of these social constructs in medical interactions has the potential
      for development of a comprehensive care model that methodically evaluates the self-assessed
      decision making influences and needs of adolescents at various stages in oncology care.

      This qualitative construct-defining study represents an initial step in the development of
      enhanced interventions for improved psychosocial support in this vulnerable population.
PRIMARY OBJECTIVES:

        -  Describe the ways relationships and social interactions may factor into adolescent study
           participants' approach to decisions;

        -  By reports from adolescents with cancer, identify behaviors from members of the study
           participants' social network that would be helpful to adolescents in fulfilling their
           preferred role in medical decision-making and achieving the desired level of
           participation in medical decision-making;

        -  Identify adolescent participants' preferred role in medical decision making.

      SECONDARY OBJECTIVES:

        -  Develop definitions of being a "good" patient, child, sibling, and friend from
           adolescent participant reports (will also welcome the study participant to self-declare
           any additional relational constructs they may wish to report);

        -  Describe how the adolescent study participant believes his or her "good" patient, child,
           sibling, and friend definition may have changed over time;

        -  Describe the self-assessed positive and negative aspects of trying to achieve the
           meanings of the "good" patient, child, sibling, and friend constructs from adolescent
           participant reports;

        -  Describe the actions of members of the study participant's social network which may help
           the study participant reach his/her definition of being a "good" patient, child,
           sibling, and friend.

      Participants will participate in a one-time voice-recorded, face-to-face interview consisting
      of open-ended questions. Completion of the interview is expected to take less than one hour.

      The qualitative interview consists of thirty open-ended questions for participants with no
      siblings and thirty-eight open-ended questions for participants who have siblings. Questions
      will be audio-recorded, face-to-face semi-structured in-depth interview format. Health
      information will also be collected from medical records.

      Expected accrual is 100 participants, 50 at each participating site. Accrual will be halted
      when the study reaches qualitative theme saturation. For this study, saturation will occur
      when three consecutive interviews fail to raise a new theme.
observational model: Cohort
time perspective: Prospective
measure: Factors contributing to decision-making
time frame: Once, at enrollment
description: Describe the ways relationships and social interactions may factor into adolescent study participants' approach to decisions.
measure: Behaviors that make a positive impact on decision-making
time frame: Once, at enrollment
description: By reports from adolescents with cancer, identify behaviors from members of the study participants' social network that would be helpful to adolescents in fulfilling their preferred role in medical decision-making and achieving the desired level of participation in medical decision-making.
measure: Preferred decision-making role
time frame: Once, at enrollment
description: Identify adolescent participants' preferred role in medical decision making.
arm group label: Study Participants
description: All enrolled participants will take part in a face-to-face interview.
intervention type: Other
intervention name: Interview
description: This study involves teen participants taking part in one private interview with the study team. Interviews last less than one hour and are scheduled at the participant's convenience. Interviews will be audio/digital recorded. Participants may answer any or all of the questions.
arm group label: Study Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 19 Years
healthy volunteers: No
last name: Meaghann Weaver, MD
role: Principal Investigator
affiliation: St. Jude Children's Research Hospital
facility: 
facility: 
country: United States
url: http://www.stjude.org
description: St. Jude Children's Research Hospital
url: http://www.stjude.org/protocols
description: Clinical Trials Open at St. Jude
responsible party type: Sponsor
mesh term: Hematologic Neoplasms