Burnout SyndromeCARE-ONCNCT07459868
Self-Care Program and Burnout Prevention in First-Year Medical Oncology Residents (Mixed-Methods Quasi-Experimental Study)
A study testing Self-Care and Burnout Prevention Program in people with Burnout Syndrome and Professional Burnout, run by Fundacion Arturo Lopez Perez.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout Syndrome, Professional Burnout
- What is being tested?
- Self-Care and Burnout Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First-year medical oncology residents at FALP; continued residency enrollment; minimum attendance requirement per protocol (≥75%).
Who cannot join
- Maternity leave during the study period.
- Interruption/withdrawal from the residency program.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Burnout Syndrome, Professional Burnout
- Being tested
- Self-Care and Burnout Prevention Program
- Keywords
- medical oncology residents, burnout syndrome, self care program
- Medical subject headings
- Burnout, Psychological, Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Care and Burnout Prevention ProgramBehavioural
(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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-Care and Burnout Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout (MBI-HSS domains). Maslach Buront Inventory
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) domains: Emotional Exhaustion, Depersonalization, and Personal Accomplishment.
Measured: Baseline and repeated every 3 mmonths during 12 months (per protocol schedule)
Secondary outcomes (1)
Baseline burnout prevalence (baseline).
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) domains: Emotional Exhaustion, Depersonalization, and Personal Accomplishment. at baseline
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start2 Mar 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Burnout SyndromeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Arturo Lopez Perez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole M Caire, Medical Oncologist, Principal investigator, Fundacion Arturo Lopez PerezDaniela A Reinhardt, Psychologist, Study chair, Fundación Arturo Lopez PérezVictor M Tapia, Drama Therapist, Study chair, Fundacion Arturo Lopez Perez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459868
- Sponsor's protocol ID
- UIEC-179
- Acronym
- CARE-ONC
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Recruitment and Adherence rates to the program Baseline results of the MBI
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.
PubMed 37867478West 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.
PubMed 24515493Kannai 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.
PubMed 39085974Krasner 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.
PubMed 19773563Rojas 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.
PubMed 37352295Joshi 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.
PubMed 36121655Araujo 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.
PubMed 38912141West 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.
PubMed 27692469Panagioti M, Geraghty K, Johnson J, Zhou A, Panagopoulou E, Chew-Graham C, Peters D, Hodkinson A, Riley R, Esmail A. Association Between Physician Burnout and Patient Safety, Professionalism, and Patient Satisfaction: A Systematic Review and Meta-analysis. JAMA Intern Med. 2018 Oct 1;178(10):1317-1331. doi: 10.1001/jamainternmed.2018.3713.
PubMed 30193239Hlubocky FJ, Taylor LP, Marron JM, Spence RA, McGinnis MM, Brown RF, McFarland DC, Tetzlaff ED, Gallagher CM, Rosenberg AR, Popp B, Dragnev K, Bosserman LD, Dudzinski DM, Smith S, Chatwal M, Patel MI, Markham MJ, Levit K, Bruera E, Epstein RM, Brown M, Back AL, Shanafelt TD, Kamal AH. A Call to Action: Ethics Committee Roundtable Recommendations for Addressing Burnout and Moral Distress in Oncology. JCO Oncol Pract. 2020 Apr;16(4):191-199. doi: 10.1200/JOP.19.00806. Epub 2020 Mar 30.
PubMed 32223701LeNoble CA, Pegram R, Shuffler ML, Fuqua T, Wiper DW 3rd. To Address Burnout in Oncology, We Must Look to Teams: Reflections on an Organizational Science Approach. JCO Oncol Pract. 2020 Apr;16(4):e377-e383. doi: 10.1200/JOP.19.00631. Epub 2020 Feb 19.
PubMed 32074017Alabi RO, Hietanen P, Elmusrati M, Youssef O, Almangush A, Makitie AA. Mitigating Burnout in an Oncological Unit: A Scoping Review. Front Public Health. 2021 Oct 1;9:677915. doi: 10.3389/fpubh.2021.677915. eCollection 2021.
PubMed 34660505Banerjee S, Califano R, Corral J, de Azambuja E, De Mattos-Arruda L, Guarneri V, Hutka M, Jordan K, Martinelli E, Mountzios G, Ozturk MA, Petrova M, Postel-Vinay S, Preusser M, Qvortrup C, Volkov MNM, Tabernero J, Olmos D, Strijbos MH. Professional burnout in European young oncologists: results of the European Society for Medical Oncology (ESMO) Young Oncologists Committee Burnout Survey. Ann Oncol. 2017 Jul 1;28(7):1590-1596. doi: 10.1093/annonc/mdx196.
PubMed 28449049Shanafelt T, Dyrbye L. Oncologist burnout: causes, consequences, and responses. J Clin Oncol. 2012 Apr 10;30(11):1235-41. doi: 10.1200/JCO.2011.39.7380. Epub 2012 Mar 12.
PubMed 22412138Sobczuk P, Gawlik-Urban A, Sigorski D, Kiszka J, Osmola M, Machulska-Ciuraj K, Wilk M, Brodziak A. Prevalence and factors associated with professional burnout in Polish oncologists-results of a nationwide survey. ESMO Open. 2024 Feb;9(2):102230. doi: 10.1016/j.esmoop.2023.102230. Epub 2024 Jan 23.
PubMed 38266421
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07459868
- Acronym / sponsor ID
- CARE-ONC / UIEC-179
- Conditions
- Burnout Syndrome, Professional Burnout
- Keywords
- medical oncology residents, burnout syndrome, self care program
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Fundacion Arturo Lopez PerezUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 Mar 2026 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self-Care and Burnout Prevention Program | Experimental | Behavioral: Self-Care and Burnout Prevention ProgramFirst-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First-year medical oncology residents at FALP; continued residency enrollment; minimum attendance requirement per protocol (≥75%).
Key exclusion criteria (2 listed)
- Maternity leave during the study period.
- Interruption/withdrawal from the residency program.
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 |
|---|---|---|
| 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. | Behavioural | Self-Care and Burnout Prevention Program |
Primary outcome
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.
1 secondary outcome
Baseline burnout prevalence (baseline).
Time frame: At Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Background: PubMed 37867478Cufer 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.
- Background: PubMed 24515493West 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.
- Background: PubMed 39085974Kannai 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.
- Background: PubMed 19773563Krasner 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.
- Background: PubMed 37352295Rojas 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.
- Background: PubMed 36121655Joshi 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.
- Background: PubMed 38912141Araujo 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.
- Background: PubMed 27692469West 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.
- Background: PubMed 30193239Panagioti M, Geraghty K, Johnson J, Zhou A, Panagopoulou E, Chew-Graham C, Peters D, Hodkinson A, Riley R, Esmail A. Association Between Physician Burnout and Patient Safety, Professionalism, and Patient Satisfaction: A Systematic Review and Meta-analysis. JAMA Intern Med. 2018 Oct 1;178(10):1317-1331. doi: 10.1001/jamainternmed.2018.3713.
- Background: PubMed 32223701Hlubocky FJ, Taylor LP, Marron JM, Spence RA, McGinnis MM, Brown RF, McFarland DC, Tetzlaff ED, Gallagher CM, Rosenberg AR, Popp B, Dragnev K, Bosserman LD, Dudzinski DM, Smith S, Chatwal M, Patel MI, Markham MJ, Levit K, Bruera E, Epstein RM, Brown M, Back AL, Shanafelt TD, Kamal AH. A Call to Action: Ethics Committee Roundtable Recommendations for Addressing Burnout and Moral Distress in Oncology. JCO Oncol Pract. 2020 Apr;16(4):191-199. doi: 10.1200/JOP.19.00806. Epub 2020 Mar 30.
- Background: PubMed 32074017LeNoble CA, Pegram R, Shuffler ML, Fuqua T, Wiper DW 3rd. To Address Burnout in Oncology, We Must Look to Teams: Reflections on an Organizational Science Approach. JCO Oncol Pract. 2020 Apr;16(4):e377-e383. doi: 10.1200/JOP.19.00631. Epub 2020 Feb 19.
- Background: PubMed 34660505Alabi RO, Hietanen P, Elmusrati M, Youssef O, Almangush A, Makitie AA. Mitigating Burnout in an Oncological Unit: A Scoping Review. Front Public Health. 2021 Oct 1;9:677915. doi: 10.3389/fpubh.2021.677915. eCollection 2021.
- Individual participant dataSharing planned: Yes. Recruitment and Adherence rates to the program Baseline results of the MBI
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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.
Nicole M Caire, Medical Oncologist principal investigator
Fundacion Arturo Lopez Perez
Daniela A Reinhardt, Psychologist study chair
Fundación Arturo Lopez Pérez
Victor M Tapia, Drama Therapist study chair
Fundacion Arturo Lopez Perez
Questions about this trial
What is this clinical trial studying?
A study testing Self-Care and Burnout Prevention Program in people with Burnout Syndrome and Professional Burnout, run by Fundacion Arturo Lopez Perez.
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 1 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: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole M Caire, Medical Oncologist (+56974998222, nicole.caire@falp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burnout (MBI-HSS domains). Maslach Buront Inventory (time frame: Baseline and repeated every 3 mmonths during 12 months (per protocol schedule)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07459868, which also lists 23 linked publications.
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 11 Mar 2026.