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Not yet recruiting NCT07459868

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

No phase Interventional Burnout Syndrome Professional Burnout

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-Care and Burnout Prevention Program.
Who it may be relevant to
Registry conditions: Burnout Syndrome, Professional Burnout. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Burnout (MBI-HSS domains). Maslach Buront Inventory [Time frame: Baseline and repeated every 3 mmonths during 12 months (per protocol schedule)]
Secondary outcome measures (1)
  • Baseline burnout prevalence (baseline). [Time frame: At Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Cufer T, Kosty MP; Curriculum Development Subgroup-ESMO/ASCO Global Curriculum Working Group. ESMO/ASCO Recommendations for a Global Curriculum in Medical Oncology Edition 2023. JCO Glob Oncol. 2023 Sep;9:e2300277. doi: 10.1200/GO.23.00277. PMID 37867478
  • West CP, Dyrbye LN, Rabatin JT, Call TG, Davidson JH, Multari A, Romanski SA, Hellyer JM, Sloan JA, Shanafelt TD. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):527-33. doi: 10.1001/jamainternmed.2013.14387. PMID 24515493
  • Kannai R, Krontal S, Freud T, Biderman A. Balint groups: an effective tool for improving health professionals' perceived well-being. Isr J Health Policy Res. 2024 Aug 1;13(1):31. doi: 10.1186/s13584-024-00618-8. PMID 39085974
  • Krasner MS, Epstein RM, Beckman H, Suchman AL, Chapman B, Mooney CJ, Quill TE. Association of an educational program in mindful communication with burnout, empathy, and attitudes among primary care physicians. JAMA. 2009 Sep 23;302(12):1284-93. doi: 10.1001/jama.2009.1384. PMID 19773563
  • Rojas B, Catalan E, Diez G, Roca P. A compassion-based program to reduce psychological distress in medical students: A pilot randomized clinical trial. PLoS One. 2023 Jun 23;18(6):e0287388. doi: 10.1371/journal.pone.0287388. eCollection 2023. PMID 37352295
  • Joshi SP, Wong AI, Brucker A, Ardito TA, Chow SC, Vaishnavi S, Lee PJ. Efficacy of Transcendental Meditation to Reduce Stress Among Health Care Workers: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231917. doi: 10.1001/jamanetworkopen.2022.31917. PMID 36121655
  • Araujo D, Bartolo A, Fernandes C, Pereira A, Monteiro S. Intervention Programs Targeting Burnout in Health Professionals: A Systematic Review. Iran J Public Health. 2024 May;53(5):997-1008. doi: 10.18502/ijph.v53i5.15580. PMID 38912141
  • West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28. PMID 27692469

Identifiers

NCT: NCT07459868 · UIEC-179

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗