Self-Care Program and Burnout Prevention in First-Year Medical Oncology Residents (Mixed-Methods Quasi-Experimental Study) (CARE-ONC)

March 10, 2026 updated by: Fundacion Arturo Lopez Perez

A Prospective Mixed-Methods Quasi-Experimental Study Evaluating Burnout Variation Over 12 Months and the Influence of a Self-Care and Burnout Prevention Program in First-Year Medical Oncology Residents

Burnout is highly prevalent among oncology clinicians, including residents in training. This prospective, mixed-methods, quasi-experimental study will evaluate how burnout changes over 12 months during the first year of medical oncology residency and explore which work-related, professional identity, and program support factors influence this variation.

Residents will participate in a structured self-care and burnout prevention program with multiple modules (e.g., yoga, mindfulness, art therapy, music therapy, Balint groups, workshops, mentorship). Quantitative burnout outcomes will be measured using the Maslach Burnout Inventory (MBI-HSS), and qualitative insights will be collected through individual semi-structured interviews. The study will also describe sociodemographic characteristics, baseline burnout prevalence, participation/adherence, satisfaction, and implementation barriers/facilitators.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Population: first-year medical oncology residents affiliated with FALP. Design: prospective mixed-methods convergent parallel quasi-experimental study. Quantitative component uses MBI-HSS. Qualitative component consists of individual semi-structured interviews.

Program participation and attendance across modules will be tracked. Satisfaction and perceived usefulness will be assessed at program completion. Feedback from participants and faculty will be analyzed to identify barriers and facilitators and to optimize future cohorts. The burnout prevention program lasts 12 months; overall project execution is planned for 14 months to complete follow-ups.

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • 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 Contact

Study Contact Backup

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • First-year medical oncology residents at FALP; continued residency enrollment; minimum attendance requirement per protocol (≥75%).

Exclusion Criteria:

  • Maternity leave during the study period.
  • Interruption/withdrawal from the residency program.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Care and Burnout Prevention Program
First-year medical oncology residents participate in a structured wellness program delivered over 12 months. Attendance is tracked, and feedback is collected to evaluate satisfaction and implementation.
Behavioral: Self-Care and Burnout Prevention Program
(EN): Multi-component wellness program delivered over 12 months (e.g., yoga, mindfulness, art therapy, music therapy, Balint groups, workshops, mentorship). Attendance/adherence is tracked; participant feedback is collected to evaluate satisfaction and implementation barriers/facilitators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burnout (MBI-HSS domains). Maslach Buront Inventory
Time Frame: Baseline and repeated every 3 mmonths during 12 months (per protocol schedule)
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) domains: Emotional Exhaustion, Depersonalization, and Personal Accomplishment.
Baseline and repeated every 3 mmonths during 12 months (per protocol schedule)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline burnout prevalence (baseline).
Time Frame: At Baseline
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) domains: Emotional Exhaustion, Depersonalization, and Personal Accomplishment. at baseline
At Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance rate to scheduled program sessions (%)
Time Frame: throughout 12 months (complete duration of the program)

Attendance will be calculated as: (number of scheduled sessions attended ÷ number of scheduled sessions offered) × 100 over the 12-month program. Attendance will be documented using program session attendance logs (and stored in REDCap). This aligns with the objective to characterize adherence/participation by quantifying attendance.Unit of Measure:

Percent (%)
throughout 12 months (complete duration of the program)
Overall program satisfaction score assessed by post-program satisfaction survey (Likert 1-5)
Time Frame: At program completion (12 months)

Participants will complete a post-program quantitative satisfaction survey at program completion. Overall satisfaction will be rated on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Results will be summarized as mean (SD) and/or median (IQR).Unit of Measure:

Score (1-5)
At program completion (12 months)
Identification of barriers and facilitators to implementation
Time Frame: Throughout 12 months (complete duration of the program)
To identify barriers and facilitators to program implementation and participation, explored through qualitative analysis of semi-structured interviews and participant feedback, including organizational, workload-related, personal, and contextual factors influencing engagement and feasibility.
Throughout 12 months (complete duration of the program)
Participants completing ≥75% of scheduled program sessions (%)
Time Frame: Throughout 12 months (complete duration of the program)

A participant will be considered adherent if they complete at least 75% of the scheduled program sessions during the 12-month period. The outcome will be reported as the proportion of participants meeting this threshold. This is consistent with the protocol criterion of ≥75% session completion.Unit of Measure:

Percent (%)
Throughout 12 months (complete duration of the program)
Perceived usefulness of the program assessed by post-program usefulness survey (Likert 1-5)
Time Frame: At program completion (12 months)

Participants will complete a post-program quantitative usefulness survey at program completion. Perceived usefulness will be rated on a 5-point Likert scale (1 = not useful at all, 5 = extremely useful). Results will be summarized as mean (SD) and/or median (IQR).Unit of Measure:

(1-5)
At program completion (12 months)
Qualitative feedback on satisfaction and usefulness assessed by end-of-program open-ended survey responses (themes)
Time Frame: At program completion (12 months)
Qualitative feedback regarding satisfaction, perceived usefulness, and perceived impact of program components will be collected through open-ended questions at program completion. Responses will be analyzed using thematic analysis to identify key themes (barriers, facilitators, perceived relevance/acceptability/impact).Unit of Measure: Themes (qualitative)
At program completion (12 months)

Collaborators and Investigators

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

Sponsor

Fundacion Arturo Lopez Perez

Investigators

  • Principal Investigator: Nicole M Caire, Medical Oncologist, Fundacion Arturo Lopez Perez
  • Study Chair: Daniela A Reinhardt, Psychologist, Fundacion Arturo Lopez Perez
  • Study Chair: Victor M Tapia, Drama Therapist, Fundacion Arturo Lopez Perez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

March 2, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIEC-179

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Recruitment and Adherence rates to the program Baseline results of the MBI

IPD Sharing Time Frame

Aggregate, de-identified data will be made available after completion of data collection and publication of the primary study results, approximately 6 to 12 months after study completion, and for 3 years after the study completion

IPD Sharing Access Criteria

Access will be granted to qualified researchers upon reasonable request for academic, non-commercial purposes. Requests must include a brief research proposal and will be subject to approval by the study investigators. Only aggregate, fully de-identified data will be shared, in accordance with institutional policies and ethical approvals.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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