Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 3:50 AM
Study NCT ID:
NCT07459868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Care Program and Burnout Prevention in First-Year Medical Oncology Residents (Mixed-Methods Quasi-Experimental Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D002055', 'term': 'Burnout, Professional'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012648', 'term': 'Self Care'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Attendance rate to scheduled program sessions (%)', 'timeFrame': 'throughout 12 months (complete duration of the program)', 'description': '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:\n\nPercent (%)'}, {'measure': 'Overall program satisfaction score assessed by post-program satisfaction survey (Likert 1-5)', 'timeFrame': 'At program completion (12 months)', 'description': '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:\n\nScore (1-5)'}, {'measure': 'Identification of barriers and facilitators to implementation', 'timeFrame': 'Throughout 12 months (complete duration of the program)', 'description': '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.'}, {'measure': 'Participants completing ≥75% of scheduled program sessions (%)', 'timeFrame': 'Throughout 12 months (complete duration of the program)', 'description': '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:\n\nPercent (%)'}, {'measure': 'Perceived usefulness of the program assessed by post-program usefulness survey (Likert 1-5)', 'timeFrame': 'At program completion (12 months)', 'description': '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:\n\n(1-5)'}, {'measure': 'Qualitative feedback on satisfaction and usefulness assessed by end-of-program open-ended survey responses (themes)', 'timeFrame': 'At program completion (12 months)', 'description': '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)'}], 'primaryOutcomes': [{'measure': 'Burnout (MBI-HSS domains). Maslach Buront Inventory', 'timeFrame': 'Baseline and repeated every 3 mmonths during 12 months (per protocol schedule)', 'description': 'Maslach Burnout Inventory-Human Services Survey (MBI-HSS) domains: Emotional Exhaustion, Depersonalization, and Personal Accomplishment.'}], 'secondaryOutcomes': [{'measure': 'Baseline burnout prevalence (baseline).', 'timeFrame': 'At Baseline', 'description': 'Maslach Burnout Inventory-Human Services Survey (MBI-HSS) domains: Emotional Exhaustion, Depersonalization, and Personal Accomplishment. at baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['medical oncology residents', 'burnout syndrome', 'self care program'], 'conditions': ['Burnout Syndrome', 'Professional Burnout']}, 'referencesModule': {'references': [{'pmid': '37867478', 'type': 'BACKGROUND', 'citation': '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': '24515493', 'type': 'BACKGROUND', 'citation': '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': '39085974', 'type': 'BACKGROUND', 'citation': "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': '19773563', 'type': 'BACKGROUND', 'citation': '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': '37352295', 'type': 'BACKGROUND', 'citation': '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': '36121655', 'type': 'BACKGROUND', 'citation': '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': '38912141', 'type': 'BACKGROUND', 'citation': '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': '27692469', 'type': 'BACKGROUND', 'citation': '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': '30193239', 'type': 'BACKGROUND', 'citation': 'Panagioti 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.', 'retractions': [{'pmid': '32421149', 'source': 'JAMA Intern Med. 2020 Jul 1;180(7):931'}]}, {'pmid': '32223701', 'type': 'BACKGROUND', 'citation': 'Hlubocky 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.'}, {'pmid': '32074017', 'type': 'BACKGROUND', 'citation': 'LeNoble 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.'}, {'pmid': '34660505', 'type': 'BACKGROUND', 'citation': 'Alabi 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.'}, {'pmid': '28449049', 'type': 'BACKGROUND', 'citation': 'Banerjee 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.'}, {'pmid': '22412138', 'type': 'BACKGROUND', 'citation': 'Shanafelt 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.'}, {'pmid': '38266421', 'type': 'BACKGROUND', 'citation': 'Sobczuk 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.'}, {'pmid': '39879569', 'type': 'BACKGROUND', 'citation': 'Schenkel C, Levit LA, Kirkwood K, Shanafelt T, Subbiah IM. Ten-Year Trends in Clinician Well-Being and Burnout Among Oncology Fellows in Training: An ASCO State of Cancer Care in America Study. JCO Oncol Pract. 2025 Jul;21(7):1039-1044. doi: 10.1200/OP.24.00200. Epub 2025 Jan 29.'}, {'pmid': '34325108', 'type': 'BACKGROUND', 'citation': 'Jimenez-Labaig P, Pacheco-Barcia V, Cebria A, Galvez F, Obispo B, Paez D, Quilez A, Quintanar T, Ramchandani A, Remon J, Rogado J, Sanchez DA, Sanchez-Canovas M, Sanz-Garcia E, Sesma A, Tarazona N, Cotes A, Gonzalez E, Bosch-Barrera J, Fernandez A, Felip E, Vera R, Rodriguez-Lescure A, Elez E. Identifying and preventing burnout in young oncologists, an overwhelming challenge in the COVID-19 era: a study of the Spanish Society of Medical Oncology (SEOM). ESMO Open. 2021 Aug;6(4):100215. doi: 10.1016/j.esmoop.2021.100215. Epub 2021 Jul 26.'}, {'pmid': '20627537', 'type': 'BACKGROUND', 'citation': 'Blanchard P, Truchot D, Albiges-Sauvin L, Dewas S, Pointreau Y, Rodrigues M, Xhaard A, Loriot Y, Giraud P, Soria JC, Kantor G. Prevalence and causes of burnout amongst oncology residents: a comprehensive nationwide cross-sectional study. Eur J Cancer. 2010 Oct;46(15):2708-15. doi: 10.1016/j.ejca.2010.05.014. Epub 2010 Jun 4.'}, {'pmid': '33013115', 'type': 'BACKGROUND', 'citation': 'Noronha J, Malik A, Bindhulakshmi P, Karimundackal G. Oncology Residency-a Burning Issue, Results of a Questionnaire-Based Survey on Psychological Well-being of Oncology Residents. Indian J Surg Oncol. 2020 Sep;11(3):387-393. doi: 10.1007/s13193-020-01183-7. Epub 2020 Aug 3.'}, {'pmid': '27249706', 'type': 'BACKGROUND', 'citation': 'Hlubocky FJ, Back AL, Shanafelt TD. Addressing Burnout in Oncology: Why Cancer Care Clinicians Are At Risk, What Individuals Can Do, and How Organizations Can Respond. Am Soc Clin Oncol Educ Book. 2016;35:271-9. doi: 10.1200/EDBK_156120.'}, {'pmid': '39906334', 'type': 'BACKGROUND', 'citation': 'Schenkel C, Levit LA, Kirkwood K, Spence R, Burke JM, Gallagher CM, Garrett-Mayer E, McGinnis M, Morgante JD, Page RD, Paice J, Tetzlaff E, Winer E, Hlubocky FJ, Shanafelt T. State of Professional Well-Being, Satisfaction, and Career Plans Among US Oncologists in 2023. JCO Oncol Adv. 2025 Jan 29;2(1):e2400010. doi: 10.1200/OA.24.00010. eCollection 2025.'}, {'pmid': '39461774', 'type': 'BACKGROUND', 'citation': "Lim KHJ, Kamposioras K, Elez E, Haanen JBAG, Hardy C, Murali K, O'Connor M, Oing C, Punie K, de Azambuja E, Blay JY, Banerjee S; ESMO Resilience Task Force. ESMO Resilience Task Force recommendations to manage psychosocial risks, optimise well-being, and reduce burnout in oncology. ESMO Open. 2024 Oct;9(10):103634. doi: 10.1016/j.esmoop.2024.103634. Epub 2024 Sep 10."}, {'pmid': '38653640', 'type': 'BACKGROUND', 'citation': 'Pujol-de Castro A, Valerio-Rao G, Vaquero-Cepeda P, Catala-Lopez F. [Prevalence of burnout syndrome in physicians working in Spain: systematic review and meta-analysis]. Gac Sanit. 2024;38:102384. doi: 10.1016/j.gaceta.2024.102384. Epub 2024 Apr 22. Spanish.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nResidents 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.', 'detailedDescription': '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.\n\nProgram 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-year medical oncology residents at FALP; continued residency enrollment; minimum attendance requirement per protocol (≥75%).\n\nExclusion Criteria:\n\n* Maternity leave during the study period.\n* Interruption/withdrawal from the residency program.'}, 'identificationModule': {'nctId': 'NCT07459868', 'acronym': 'CARE-ONC', 'briefTitle': 'Self-Care Program and Burnout Prevention in First-Year Medical Oncology Residents (Mixed-Methods Quasi-Experimental Study)', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Arturo Lopez Perez'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'UIEC-179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-Care and Burnout Prevention Program', 'description': '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.', 'interventionNames': ['Behavioral: Self-Care and Burnout Prevention Program']}], 'interventions': [{'name': 'Self-Care and Burnout Prevention Program', 'type': 'BEHAVIORAL', 'description': '(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.', 'armGroupLabels': ['Self-Care and Burnout Prevention Program']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nicole M Caire, Medical Oncologist', 'role': 'CONTACT', 'email': 'nicole.caire@falp.org', 'phone': '+56974998222'}, {'name': 'Claudia C Chavez, Master of Science in Biostatis', 'role': 'CONTACT', 'email': 'claudia.chavezo@falp.org', 'phone': '+56966172416'}], 'overallOfficials': [{'name': 'Nicole M Caire, Medical Oncologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundacion Arturo Lopez Perez'}, {'name': 'Daniela A Reinhardt, Psychologist', 'role': 'STUDY_CHAIR', 'affiliation': 'Fundación Arturo Lopez Pérez'}, {'name': 'Victor M Tapia, Drama Therapist', 'role': 'STUDY_CHAIR', 'affiliation': 'Fundacion Arturo Lopez Perez'}]}, 'ipdSharingStatementModule': {'url': 'http://www.falp.org', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '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', 'ipdSharing': 'YES', 'description': 'Recruitment and Adherence rates to the program Baseline results of the MBI', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Arturo Lopez Perez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}