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.
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
- Conditions the study is for
- Pediatric Residents Rotating in Pediatric Oncology
- 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
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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Intervention | Experimental | Subjects 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.
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
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.
- First posted28 Jul 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Residents Rotating in Pediatric OncologyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel H Kowalsky, MD, Principal investigator, Weill Medical College of Cornell University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can A Narrative Medicine Curriculum Impact Burnout Scores and Quality of Life for Residents on the Pediatric Oncology Service?
- ClinicalTrials.gov ID
- NCT04489316
- Acronym / sponsor ID
- 19-05020097
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Intervention | Experimental | Other: Narrative medicine curriculumSubjects in the Intervention group will receive 2-3 sessions in narrative medicine. They will also take the pretest and the postest. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative medicine curriculumAlso: Educational curriculumThe curriculum will consist of three sessions in narrative medicine- i.e. discussing texts and poetry, and engaging in reflective writing as a group | Other | Intervention |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel H Kowalsky, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
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.