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Pediatric Residents Rotating in Pediatric OncologyNCT04489316

Narrative Medicine and Pediatric Oncology

A study testing Narrative medicine curriculum in people with Pediatric Residents Rotating in Pediatric Oncology, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age
What is being tested?
Narrative medicine curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
1 Jul 2020to 1 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Narrative medicine curriculum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Narrative medicine curriculumOther

    Also called Educational 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

Study groups in NCT04489316
Study groupRoleWhat they receive
ControlNo interventionSubjects 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.
InterventionExperimentalSubjects in the Intervention group will receive 2-3 sessions in narrative medicine. They will also take the pretest and the postest.
Receives: Other: Narrative medicine curriculum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Burnout, as measured by the Maslach Burnout Inventory-Human Services Survey (MBI-HSS)

    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)

    Measured: Baseline, 3 weeks

  2. Change in Professional quality of life, as measured by Professional Quality of Life Scale: Compassion Satisfaction, Burnout, and Fatigue Scale Version V (ProQOL)

    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)

    Measured: Baseline, 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2020
  2. Study start1 Jul 2020
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04489316
Sponsor's protocol ID
19-05020097
Status last verified
Sep 2021
First submitted
24 Jul 2020
Last updated
23 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Narrative medicine curriculum in people with Pediatric Residents Rotating in Pediatric Oncology, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Burnout, as measured by the Maslach Burnout Inventory-Human Services Survey (MBI-HSS) (time frame: Baseline, 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.

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