NCT Number: NCT07459868
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(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.
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.
Time frame: At Baseline
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) domains: Emotional Exhaustion, Depersonalization, and Personal Accomplishment. at baseline
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 (%)
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)
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.
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 (%)
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)
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)
Contact information is provided by the study sponsor or research team.
Claudia C Chavez, Master of Science in Biostatis
CONTACT
Nicole M Caire, Medical Oncologist
CONTACT
Fundacion Arturo Lopez Perez
Other
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
Acronym: CARE-ONC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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