Narrative Medicine and Pediatric Oncology

September 21, 2021 updated by: Weill Medical College of Cornell University

Can A Narrative Medicine Curriculum Impact Burnout Scores and Quality of Life for Residents on the Pediatric Oncology Service?

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric residents
  • Rotating through Memorial Sloan Kettering Cancer Center during the 2020-2021 academic year
  • Who complete at least 2 sessions in narrative medicine, including the pre-test and post-test.

Exclusion Criteria:

  • Residents who are on an elective rotation, rather than a compulsory rotation,
  • Residents who have already rotated once through MSKCC during the Jan 2020-Jan 2021 calendar year if their first rotation was an intervention block.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
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.
Experimental: Intervention
Subjects in the Intervention group will receive 2-3 sessions in narrative medicine. They will also take the pretest and the postest.
Other: Narrative medicine curriculum
The curriculum will consist of three sessions in narrative medicine- i.e. discussing texts and poetry, and engaging in reflective writing as a group
Other Names:
  • Educational curriculum

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Burnout, as measured by the Maslach Burnout Inventory-Human Services Survey (MBI-HSS)
Time Frame: Baseline, 3 weeks

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)
Baseline, 3 weeks
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

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)
Baseline, 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel H Kowalsky, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-05020097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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