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

NCT07459868 | Not Yet Recruiting

• 1 other identifier: UIEC-179
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Burnout Syndrome; Professional Burnout

Keywords

medical oncology residents; burnout syndrome; self care program

Outcome Measures

Primary Outcomes (1)

• Burnout (MBI-HSS domains). Maslach Buront Inventory

  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 Outcomes (1)

• Baseline burnout prevalence (baseline).

  At Baseline

Other Outcomes (6)

• Attendance rate to scheduled program sessions (%)

  throughout 12 months (complete duration of the program)

• Overall program satisfaction score assessed by post-program satisfaction survey (Likert 1-5)

  At program completion (12 months)

• Identification of barriers and facilitators to implementation

  Throughout 12 months (complete duration of the program)

Study Arms (1)

Self-Care and Burnout Prevention Program

EXPERIMENTAL

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

Interventions

Self-Care and Burnout Prevention Program BEHAVIORAL

(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.

Self-Care and Burnout Prevention Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion Arturo Lopez Perez: lead

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MeSH Terms

Conditions

Burnout, Psychological; Burnout, Professional

Interventions

Self Care

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Occupational Stress; Occupational Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nicole M Caire, Medical Oncologist

  Fundacion Arturo Lopez Perez

  PRINCIPAL INVESTIGATOR

• Daniela A Reinhardt, Psychologist

  Fundación Arturo Lopez Pérez

  STUDY CHAIR

• Victor M Tapia, Drama Therapist

  Fundacion Arturo Lopez Perez

  STUDY CHAIR

Central Study Contacts

Nicole M Caire, Medical Oncologist

CONTACT

+56974998222; nicole.caire@falp.org

Claudia C Chavez, Master of Science in Biostatis

CONTACT

+56966172416; claudia.chavezo@falp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-center, quasi-experimental interventional study using a mixed-methods longitudinal design. All eligible first-year medical oncology residents participate in a structured well-being and burnout prevention program delivered over a 12-month period. The intervention consists of recurrent, multimodal group-based sessions (including mindfulness, yoga, art and music therapy, reflective practice, and facilitated group discussions), integrated into the residency curriculum. There is no randomization or parallel control group; each participant serves as their own comparator over time. Quantitative outcomes are assessed repeatedly using validated instruments (Maslach Burnout Inventory), complemented by qualitative data obtained through semi-structured individual interviews. This design allows evaluation of temporal changes in burnout dimensions and exploration of contextual and experiential factors influencing professional well-being.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 10, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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
• 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.