xml: <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/NCT05975333</url>
    </required_header>
    <id_info>
      <org_study_id>ChronCan</org_study_id>
      <secondary_id>NCI-2023-06074</secondary_id>
      <nct_id>NCT05975333</nct_id>
    </id_info>
    <brief_title>Writing Intervention With Adolescents and Young Adults With Cancer</brief_title>
    <official_title>ChronCan (Chronicling Cancer): Piloting a Novel Writing Intervention With Adolescents and Young Adults With Cancer</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Young people with cancer have difficult experiences and writing exercises may help improve&#xD;
        their well-being. However, very few studies have examined how a creative writing activity&#xD;
        might be useful for young people with cancer. In this pilot study, researchers at St. Jude&#xD;
        Children's Research Hospital hope to explore whether teenagers and young adults with cancer&#xD;
        want to participate in a writing exercise and whether they find it to be valuable.&#xD;
  &#xD;
        Primary Objective&#xD;
  &#xD;
        To assess the feasibility and acceptability of a writing-based narrative medicine&#xD;
        intervention for adolescent and young adult patients with cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be given the opportunity to write about their experiences with cancer, with&#xD;
        support and guidance from an expert writer. Participants will meet briefly with the expert at&#xD;
        the start of the exercise (15-30 minutes), and they can choose to meet 1-3 additional times&#xD;
        with the expert over the next 2 months to receive further support if they wish.&#xD;
  &#xD;
        After completing the writing exercise, participants will do an informal interview to share&#xD;
        their thoughts about whether the experience of writing felt helpful or not. The&#xD;
        post-intervention interview will occur at around 2 months after enrollment, +/- 1 month.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of touchpoints that participants have with the narrative medicine expert/guide</measure>
      <time_frame>During the narrative exercise, up to 2 months after enrollment</time_frame>
      <description>To determine intervention feasibility, the number of touchpoints that participants have with the narrative medicine expert/guide will be tracked</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants who complete the writing exercise</measure>
      <time_frame>During the narrative exercise, up to 2 months after enrollment</time_frame>
      <description>To determine intervention feasibility, the number of participants who complete the writing exercise will be tracked</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention acceptability</measure>
      <time_frame>Post-intervention interview will occur after the narrative exercise is completed at around 2 months after enrollment, +/- 1 month</time_frame>
      <description>Comparison of acceptability between participants who did/did not participate in the optional check-ins. Analysis of de-identified semi-structured interviews will be done. Interviews will be recorded, transcribed, de-identified, and analyzed using content analysis, an inductive approach that includes memo-writing, codebook development, coding, reconciliation, and synthesis to identify emerging patterns and themes.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Cancer Patients</condition>
    <condition>Communication Research</condition>
    <arm_group>
      <arm_group_label>Participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Adolescents and young adults (AYA) patients aged 15-25 years currently receiving cancer-directed therapy at St. Jude Children's Research Hospital</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Writing</intervention_name>
      <description>Participants will be asked to write about their experiences with cancer, guided by several specific open-ended writing prompts to spark ideas.</description>
      <arm_group_label>Participants</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Interview</intervention_name>
      <description>Following completion of the writing exercise, participants will reflect on their experiences with the writing intervention in a semi-structured private interview with a member of the research team.</description>
      <arm_group_label>Participants</arm_group_label>
      <other_name>Questions</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 15-25&#xD;
  &#xD;
            -  Currently receiving cancer-directed therapy&#xD;
  &#xD;
            -  Active patient at St. Jude Children's Research Hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Does not meet the inclusion criteria&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Trisha K. Paul, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>St. Jude Children's Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Trisha K. Paul, MD</last_name>
      <phone>866-278-5833</phone>
      <email>referralinfo@stjude.org</email>
    </overall_contact>
    <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>
      <status>Recruiting</status>
      <contact>
        <last_name>Trisha K. Paul, MD</last_name>
        <phone>866-278-5833</phone>
        <email>referralinfo@stjude.org</email>
      </contact>
    </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>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adolescents</keyword>
    <keyword>Young Adults</keyword>
    <keyword>Writing Intervention</keyword>
    <keyword>Interview</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975333
  org study id: ChronCan
  secondary id: NCI-2023-06074
  nct id: NCT05975333
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Young people with cancer have difficult experiences and writing exercises may help improve
        their well-being. However, very few studies have examined how a creative writing activity
        might be useful for young people with cancer. In this pilot study, researchers at St. Jude
        Children's Research Hospital hope to explore whether teenagers and young adults with cancer
        want to participate in a writing exercise and whether they find it to be valuable.
  
        Primary Objective
  
        To assess the feasibility and acceptability of a writing-based narrative medicine
        intervention for adolescent and young adult patients with cancer.
  Participants will be given the opportunity to write about their experiences with cancer, with
        support and guidance from an expert writer. Participants will meet briefly with the expert at
        the start of the exercise (15-30 minutes), and they can choose to meet 1-3 additional times
        with the expert over the next 2 months to receive further support if they wish.
  
        After completing the writing exercise, participants will do an informal interview to share
        their thoughts about whether the experience of writing felt helpful or not. The
        post-intervention interview will occur at around 2 months after enrollment, +/- 1 month.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Number of touchpoints that participants have with the narrative medicine expert/guide
  time frame: During the narrative exercise, up to 2 months after enrollment
  description: To determine intervention feasibility, the number of touchpoints that participants have with the narrative medicine expert/guide will be tracked
  measure: Number of participants who complete the writing exercise
  time frame: During the narrative exercise, up to 2 months after enrollment
  description: To determine intervention feasibility, the number of participants who complete the writing exercise will be tracked
  measure: Intervention acceptability
  time frame: Post-intervention interview will occur after the narrative exercise is completed at around 2 months after enrollment, +/- 1 month
  description: Comparison of acceptability between participants who did/did not participate in the optional check-ins. Analysis of de-identified semi-structured interviews will be done. Interviews will be recorded, transcribed, de-identified, and analyzed using content analysis, an inductive approach that includes memo-writing, codebook development, coding, reconciliation, and synthesis to identify emerging patterns and themes.
  arm group label: Participants
  arm group type: Experimental
  description: Adolescents and young adults (AYA) patients aged 15-25 years currently receiving cancer-directed therapy at St. Jude Children's Research Hospital
  intervention type: Behavioral
  intervention name: Writing
  description: Participants will be asked to write about their experiences with cancer, guided by several specific open-ended writing prompts to spark ideas.
  arm group label: Participants
  intervention type: Behavioral
  intervention name: Interview
  description: Following completion of the writing exercise, participants will reflect on their experiences with the writing intervention in a semi-structured private interview with a member of the research team.
  arm group label: Participants
  other name: Questions
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 25 Years
  healthy volunteers: No
  last name: Trisha K. Paul, MD
  role: Principal Investigator
  affiliation: St. Jude Children's Research Hospital
  last name: Trisha K. Paul, MD
  phone: 866-278-5833
  email: referralinfo@stjude.org
  facility: 
  status: Recruiting
  contact: 
  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