<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/NCT04489316</url>
  </required_header>
  <id_info>
    <org_study_id>19-05020097</org_study_id>
    <nct_id>NCT04489316</nct_id>
  </id_info>
  <brief_title>Narrative Medicine and Pediatric Oncology</brief_title>
  <official_title>Can A Narrative Medicine Curriculum Impact Burnout Scores and Quality of Life for Residents on the Pediatric Oncology Service?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</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 investigators' objective is to implement an innovative curriculum in narrative medicine&#xD;
      for pediatric residents rotating at Memorial Sloan Kettering Cancer Center (MSKCC), and to&#xD;
      evaluate whether this curriculum is protective against burnout and diminished quality of life&#xD;
      during that rotation as measured on The Maslach Burnout Inventory-Human Services Survey&#xD;
      (MBI-HSS) and The Professional Quality of Life Scale: Compassion Satisfaction, Burnout, and&#xD;
      Fatigue Scale Version V (ProQOL R-V).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods and Procedures This study is designed to evaluate the impact of a narrative medicine&#xD;
      curriculum on a convenience sample of pediatric residents rotating through MSKCC during the&#xD;
      2020-2021 academic year. The first block of the study period will be a control group,&#xD;
      followed by treatment (the second block). Blocks will alternate in this way for the remainder&#xD;
      of the 12 month period (control-treatment-control-treatment-control-treatment etc).&#xD;
&#xD;
      The treatment group will be offered three sessions in narrative medicine during their block&#xD;
      at MSKCC, with sessions taking place during the one-hour afternoon conference time slot. The&#xD;
      control group will proceed through the standard afternoon conference curriculum, with no&#xD;
      narrative medicine sessions.&#xD;
&#xD;
      A session in narrative medicine is defined as a one-hour session in which a pre- selected&#xD;
      piece of poetry or literary fiction is read, then responded to in written form, with the&#xD;
      option to share one's responses aloud with the group. It provides opportunity for reflection,&#xD;
      meaning-making, bearing witness to the stories of doctors and patients, and important&#xD;
      professional development. Candidate texts have been chosen by experts in narrative medicine,&#xD;
      English literature, and creative writing, and are grouped around 4 themes: caring for ill and&#xD;
      dying children and their families, forging connections, coping with uncertainty and&#xD;
      ambiguity, and mindfulness. The publishers for each piece are currently being contacted and&#xD;
      permission requested for their use in this study. While the use of works in the context of&#xD;
      this study meets Cornell University Check.list for Fair Use Criteria, some publishers charge&#xD;
      a nominal fee, up to approximately $50, for use of a complete work such as a poem. Excerpts&#xD;
      from books are typically at no charge. The cost of these permissions has been figured into&#xD;
      the study budget, and is funded by a Pilot Grant from the Dept. of Pediatrics.&#xD;
&#xD;
      Narrative medicine sessions will be standardized, and will be taught by 5 of the 6&#xD;
      co-investigator's: two from pediatric emergency medicine, one from pediatric pulmonology, one&#xD;
      from the office of the chaplain, and one from the Dept. of Child Psychiatry at MSK. All five&#xD;
      will receive training in facilitating narrative medicine sessions. They will each attend one&#xD;
      narrative medicine session at the WCMC Liz Claiborne Center for Humanism in Medicine, and&#xD;
      they will each read relevant chapters of the textbook &quot;Narrative Medicine,&quot; by Rita Charon.&#xD;
&#xD;
      A pre-test, comprised of the Maslach Burnout Inventory-Human Services Survey (MBI-HSS) and&#xD;
      the Professional Quality of Life Scale: Compassion Satisfaction, Burnout, and Fatigue Scale&#xD;
      Version V (ProQOL) will be administered to all groups during the first session of each block,&#xD;
      and demographic information will be collected, specifically post-graduate year,&#xD;
      self-identified gender, self-identified race and/or ethnicity, previous exposure to narrative&#xD;
      medicine, and previous rotations in clinical oncology. A post-test, using the same survey&#xD;
      instruments, will be administered during the final session, along with two open-ended&#xD;
      questions about their experience with this curriculum. Only the intervention group will&#xD;
      answer the two open-ended questions.&#xD;
&#xD;
      Each resident will choose a 4-digit ID number which will be written on their demographic&#xD;
      intakes and pre-and post-tests, as well as on the sign in sheet for the 2nd narrative&#xD;
      medicine session during intervention blocks. They will be asked to email their PIN to&#xD;
      themselves during the pre-test so that they will not forget the number. This identifying&#xD;
      pin-number is necessary in order to match individual pre-tests to post-tests and assess&#xD;
      degree of change for individuals over the duration of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>There will be an intervention group that receives 3 sessions in narrative medicine, and a control group that will receive the standard curriculum</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Burnout, as measured by the Maslach Burnout Inventory-Human Services Survey (MBI-HSS)</measure>
    <time_frame>Baseline, 3 weeks</time_frame>
    <description>The MBI-HSS is a 22-item self-report questionnaire comprised of 3 subscales, which measure exhaustion, depersonalization, and personal accomplishment. Respondents indicate the frequency of their signs and symptoms on a 7-point Likert scale where 0 = never and 6= every day. The highest and lowest possible scores for each of the subscales are as follows:&#xD;
Emotional exhaustion subscale (0- 54) Depersonalization subscale (0-30) Professional accomplishment scale (0-48)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Professional quality of life, as measured by Professional Quality of Life Scale: Compassion Satisfaction, Burnout, and Fatigue Scale Version V (ProQOL)</measure>
    <time_frame>Baseline, 3 weeks</time_frame>
    <description>The PROQOL R-V will be used to measure compassion satisfaction, compassion fatigue, and burnout. It is a 30 item self-report questionnaire . Subjects are instructed to indicate on a 6-point Likert scale with endpoints of 0 (never) and 5 (very often), the characteristics that relate to them. The highest and lowest possible scores for each of the subscales are as follows:&#xD;
Compassion Satisfaction subscale (3-50) Burnout subscale (3-40) Secondary traumatic stress subscale (2-37)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Pediatric Residents Rotating in Pediatric Oncology</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in the Control group will proceed through the standard pediatric oncology curriculum. They will not receive any sessions in narrative medicine. They will take the pretest and the post-test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the Intervention group will receive 2-3 sessions in narrative medicine. They will also take the pretest and the postest.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Narrative medicine curriculum</intervention_name>
    <description>The curriculum will consist of three sessions in narrative medicine- i.e. discussing texts and poetry, and engaging in reflective writing as a group</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Educational curriculum</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric residents&#xD;
&#xD;
          -  Rotating through Memorial Sloan Kettering Cancer Center during the 2020-2021 academic&#xD;
             year&#xD;
&#xD;
          -  Who complete at least 2 sessions in narrative medicine, including the pre-test and&#xD;
             post-test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Residents who are on an elective rotation, rather than a compulsory rotation,&#xD;
&#xD;
          -  Residents who have already rotated once through MSKCC during the Jan 2020-Jan 2021&#xD;
             calendar year if their first rotation was an intervention block.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel H Kowalsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04489316
org study id: 19-05020097
nct id: NCT04489316
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators' objective is to implement an innovative curriculum in narrative medicine
      for pediatric residents rotating at Memorial Sloan Kettering Cancer Center (MSKCC), and to
      evaluate whether this curriculum is protective against burnout and diminished quality of life
      during that rotation as measured on The Maslach Burnout Inventory-Human Services Survey
      (MBI-HSS) and The Professional Quality of Life Scale: Compassion Satisfaction, Burnout, and
      Fatigue Scale Version V (ProQOL R-V).
Methods and Procedures This study is designed to evaluate the impact of a narrative medicine
      curriculum on a convenience sample of pediatric residents rotating through MSKCC during the
      2020-2021 academic year. The first block of the study period will be a control group,
      followed by treatment (the second block). Blocks will alternate in this way for the remainder
      of the 12 month period (control-treatment-control-treatment-control-treatment etc).

      The treatment group will be offered three sessions in narrative medicine during their block
      at MSKCC, with sessions taking place during the one-hour afternoon conference time slot. The
      control group will proceed through the standard afternoon conference curriculum, with no
      narrative medicine sessions.

      A session in narrative medicine is defined as a one-hour session in which a pre- selected
      piece of poetry or literary fiction is read, then responded to in written form, with the
      option to share one's responses aloud with the group. It provides opportunity for reflection,
      meaning-making, bearing witness to the stories of doctors and patients, and important
      professional development. Candidate texts have been chosen by experts in narrative medicine,
      English literature, and creative writing, and are grouped around 4 themes: caring for ill and
      dying children and their families, forging connections, coping with uncertainty and
      ambiguity, and mindfulness. The publishers for each piece are currently being contacted and
      permission requested for their use in this study. While the use of works in the context of
      this study meets Cornell University Check.list for Fair Use Criteria, some publishers charge
      a nominal fee, up to approximately $50, for use of a complete work such as a poem. Excerpts
      from books are typically at no charge. The cost of these permissions has been figured into
      the study budget, and is funded by a Pilot Grant from the Dept. of Pediatrics.

      Narrative medicine sessions will be standardized, and will be taught by 5 of the 6
      co-investigator's: two from pediatric emergency medicine, one from pediatric pulmonology, one
      from the office of the chaplain, and one from the Dept. of Child Psychiatry at MSK. All five
      will receive training in facilitating narrative medicine sessions. They will each attend one
      narrative medicine session at the WCMC Liz Claiborne Center for Humanism in Medicine, and
      they will each read relevant chapters of the textbook "Narrative Medicine," by Rita Charon.

      A pre-test, comprised of the Maslach Burnout Inventory-Human Services Survey (MBI-HSS) and
      the Professional Quality of Life Scale: Compassion Satisfaction, Burnout, and Fatigue Scale
      Version V (ProQOL) will be administered to all groups during the first session of each block,
      and demographic information will be collected, specifically post-graduate year,
      self-identified gender, self-identified race and/or ethnicity, previous exposure to narrative
      medicine, and previous rotations in clinical oncology. A post-test, using the same survey
      instruments, will be administered during the final session, along with two open-ended
      questions about their experience with this curriculum. Only the intervention group will
      answer the two open-ended questions.

      Each resident will choose a 4-digit ID number which will be written on their demographic
      intakes and pre-and post-tests, as well as on the sign in sheet for the 2nd narrative
      medicine session during intervention blocks. They will be asked to email their PIN to
      themselves during the pre-test so that they will not forget the number. This identifying
      pin-number is necessary in order to match individual pre-tests to post-tests and assess
      degree of change for individuals over the duration of the study.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: There will be an intervention group that receives 3 sessions in narrative medicine, and a control group that will receive the standard curriculum
primary purpose: Other
masking: None (Open Label)
measure: Change in Burnout, as measured by the Maslach Burnout Inventory-Human Services Survey (MBI-HSS)
time frame: Baseline, 3 weeks
description: The MBI-HSS is a 22-item self-report questionnaire comprised of 3 subscales, which measure exhaustion, depersonalization, and personal accomplishment. Respondents indicate the frequency of their signs and symptoms on a 7-point Likert scale where 0 = never and 6= every day. The highest and lowest possible scores for each of the subscales are as follows:
Emotional exhaustion subscale (0- 54) Depersonalization subscale (0-30) Professional accomplishment scale (0-48)
measure: Change in Professional quality of life, as measured by Professional Quality of Life Scale: Compassion Satisfaction, Burnout, and Fatigue Scale Version V (ProQOL)
time frame: Baseline, 3 weeks
description: The PROQOL R-V will be used to measure compassion satisfaction, compassion fatigue, and burnout. It is a 30 item self-report questionnaire . Subjects are instructed to indicate on a 6-point Likert scale with endpoints of 0 (never) and 5 (very often), the characteristics that relate to them. The highest and lowest possible scores for each of the subscales are as follows:
Compassion Satisfaction subscale (3-50) Burnout subscale (3-40) Secondary traumatic stress subscale (2-37)
arm group label: Control
arm group type: No Intervention
description: Subjects in the Control group will proceed through the standard pediatric oncology curriculum. They will not receive any sessions in narrative medicine. They will take the pretest and the post-test.
arm group label: Intervention
arm group type: Experimental
description: Subjects in the Intervention group will receive 2-3 sessions in narrative medicine. They will also take the pretest and the postest.
intervention type: Other
intervention name: Narrative medicine curriculum
description: The curriculum will consist of three sessions in narrative medicine- i.e. discussing texts and poetry, and engaging in reflective writing as a group
arm group label: Intervention
other name: Educational curriculum
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Rachel H Kowalsky, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No