Randomized Controlled Trial Assessing the Efficacy of a Communication Skills Training Program

NCT02836197 | Unknown

• 1 other identifier: CERTAIN
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Although previous studies have reported the efficacy of communication skills training programs (CST), specific training addressing communication about uncertainty and hope in oncology has not yet been studied. This paper describes the study protocol of a randomized controlled trial assessing the efficacy of a CST program aimed at improving physician ability to communicate about uncertainty and hope in encounters with cancer patients. Methods: Physician participants will be randomly assigned in groups (n = 3/group) to a 30-hour CST program (experimental group) or to a waiting list (control group). The training program will include learner-centered, skills-focused, practice-oriented techniques. Training efficacy is assessed in the context of an encounter with a simulated advanced stage cancer patient at baseline and after the CST for the experimental group, and after four months for the waiting-list group. Efficacy assessments will include communicational, psychological and physiological measures. Group-by-time effects will be analyzed using a generalized estimating equation (GEE). A power analysis indicated that a sample size of 60 (30 experimental and 30 control) participants will be sufficient to detect effects. Discussion: The current study will aid in the development of effective CST programs to improve physician ability to communicate about uncertainty and hope in encounters with cancer patients.

Conditions

Physician Patient Relationship

Keywords

Uncertainty;hope;cancer;communication skills training;physicians

Outcome Measures

Primary Outcomes (1)

• Physicians' acquisition of communication skills addressing uncertainty and hope in encounters with a simulated advanced stage cancer patient through validated tools and questionnaires

  4 months

Secondary Outcomes (1)

• Improvement in physicians satisfaction regarding their communication skills addressing uncertainty and hope in encounters with a simulated advanced stage cancer patient through a questionnaire

  4 months

Study Arms (2)

Experimental group

EXPERIMENTAL

This group of 30 physicians will immediately attend the intervention communication skills training program (experimental group).For this experimental group, the first assessment will take place before the first training session and the second recording after the last session. This assessment involves the analyses of communicational, physiological and psychological variables recorded in the context of an encounter with a simulated advanced stage cancer patient.

Behavioral: Communication skills training

Waiting-list group

NO INTERVENTION

This group of 30 physicians will attend the intervention communication skills training in a delayed manner (control group). For this control group, the first and the second recording will take place with a four-month interval. This assessment involves the analyses of communicational, physiological and psychological variables recorded in the context of an encounter with a simulated advanced stage cancer patient.

Interventions

Communication skills training BEHAVIORAL

The general aim of the communication skills training program is to help physicians learn effective communication skills in contexts of high uncertainty. The training will last 30 hours, will be spread over 4 months. The training will be conducted by group of 3 subjects. The training will include mainly role-plays, theoretical information and modeling techniques. A training manual has been developed to increase content standardization and reduce potential group or trainee biases. The role-plays will be based on clinical cases brought up by the participants.

Experimental group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to speak French
• to be willing to participate in the research program
• to be oncologist, other specialist, or resident with at least one year of experience working with cancer patients (part-time or full-time).
• to provide written informed consent.

Sponsors & Collaborators

• Jules Bordet Institute: lead
• Université Libre de Bruxelles: collaborator
• Université Catholique de Louvain: collaborator
• Université de Liège: collaborator
• Centre de Psycho-Oncologie (CPO): collaborator

Study Sites (2)

Libert Yves

Brussels, 1000, Belgium

RECRUITING

Libert

Brussels, 1000, Belgium

NOT YET RECRUITING

Related Publications (22)

• Bragard I, Etienne AM, Merckaert I, Libert Y, Razavi D. Efficacy of a communication and stress management training on medical residents' self-efficacy, stress to communicate and burnout: a randomized controlled study. J Health Psychol. 2010 Oct;15(7):1075-81. doi: 10.1177/1359105310361992. Epub 2010 May 7.

  PMID: 20453053 BACKGROUND

• Bragard I, Etienne AM, Libert Y, Merckaert I, Lienard A, Meunier J, Delvaux N, Hansez I, Marchal S, Reynaert C, Slachmuylder JL, Razavi D. Predictors and correlates of burnout in residents working with cancer patients. J Cancer Educ. 2010 Mar;25(1):120-6. doi: 10.1007/s13187-010-0050-9. Epub 2010 Feb 26.

  PMID: 20186520 BACKGROUND

• Bragard I, Razavi D, Marchal S, Merckaert I, Delvaux N, Libert Y, Reynaert C, Boniver J, Klastersky J, Scalliet P, Etienne AM. Teaching communication and stress management skills to junior physicians dealing with cancer patients: a Belgian Interuniversity Curriculum. Support Care Cancer. 2006 May;14(5):454-61. doi: 10.1007/s00520-005-0008-3. Epub 2006 Jan 18.

  PMID: 16418828 BACKGROUND

• Bragard I, Libert Y, Etienne AM, Merckaert I, Delvaux N, Marchal S, Boniver J, Klastersky J, Reynaert C, Scalliet P, Slachmuylder JL, Razavi D. Insight on variables leading to burnout in cancer physicians. J Cancer Educ. 2010 Mar;25(1):109-15. doi: 10.1007/s13187-009-0026-9.

  PMID: 20082173 BACKGROUND

• Delvaux N, Merckaert I, Marchal S, Libert Y, Conradt S, Boniver J, Etienne AM, Fontaine O, Janne P, Klastersky J, Melot C, Reynaert C, Scalliet P, Slachmuylder JL, Razavi D. Physicians' communication with a cancer patient and a relative: a randomized study assessing the efficacy of consolidation workshops. Cancer. 2005 Jun 1;103(11):2397-411. doi: 10.1002/cncr.21093.

  PMID: 15858816 BACKGROUND

• Gibon AS, Merckaert I, Lienard A, Libert Y, Delvaux N, Marchal S, Etienne AM, Reynaert C, Slachmuylder JL, Scalliet P, Van Houtte P, Coucke P, Salamon E, Razavi D. Is it possible to improve radiotherapy team members' communication skills? A randomized study assessing the efficacy of a 38-h communication skills training program. Radiother Oncol. 2013 Oct;109(1):170-7. doi: 10.1016/j.radonc.2013.08.019. Epub 2013 Sep 7.

  PMID: 24021347 BACKGROUND

• Libert Y, Merckaert I, Reynaert C, Delvaux N, Marchal S, Etienne AM, Boniver J, Klastersky J, Scalliet P, Slachmuylder JL, Razavi D. Does psychological characteristic influence physicians' communication styles? Impact of physicians' locus of control on interviews with a cancer patient and a relative. Support Care Cancer. 2006 Mar;14(3):230-42. doi: 10.1007/s00520-005-0871-y. Epub 2005 Jul 29.

  PMID: 16052317 BACKGROUND

• Libert Y, Merckaert I, Reynaert C, Delvaux N, Marchal S, Etienne AM, Boniver J, Klastersky J, Scalliet P, Slachmuylder JL, Razavi D. Physicians are different when they learn communication skills: influence of the locus of control. Psychooncology. 2007 Jun;16(6):553-62. doi: 10.1002/pon.1098.

  PMID: 16988932 BACKGROUND

• Libert Y, Janne P, Razavi D, Merckaert I, Scalliet P, Delvaux N, Etienne AM, Conradt S, Klastersky J, Boniver J, Reynaert C. Impact of medical specialists' locus of control on communication skills in oncological interviews. Br J Cancer. 2003 Feb 24;88(4):502-9. doi: 10.1038/sj.bjc.6600797.

  PMID: 12592362 BACKGROUND

• Lienard A, Merckaert I, Libert Y, Delvaux N, Marchal S, Boniver J, Etienne AM, Klastersky J, Reynaert C, Scalliet P, Slachmuylder JL, Razavi D. Factors that influence cancer patients' anxiety following a medical consultation: impact of a communication skills training programme for physicians. Ann Oncol. 2006 Sep;17(9):1450-8. doi: 10.1093/annonc/mdl142. Epub 2006 Jun 26.

  PMID: 16801333 BACKGROUND

• Lienard A, Merckaert I, Libert Y, Delvaux N, Marchal S, Boniver J, Etienne AM, Klastersky J, Reynaert C, Scalliet P, Slachmuylder JL, Razavi D. Factors that influence cancer patients' and relatives' anxiety following a three-person medical consultation: impact of a communication skills training program for physicians. Psychooncology. 2008 May;17(5):488-96. doi: 10.1002/pon.1262.

  PMID: 17879970 BACKGROUND

• Lienard A, Merckaert I, Libert Y, Bragard I, Delvaux N, Etienne AM, Marchal S, Meunier J, Reynaert C, Slachmuylder JL, Razavi D. Is it possible to improve residents breaking bad news skills? A randomised study assessing the efficacy of a communication skills training program. Br J Cancer. 2010 Jul 13;103(2):171-7. doi: 10.1038/sj.bjc.6605749.

  PMID: 20628395 BACKGROUND

• Lienard A, Merckaert I, Libert Y, Bragard I, Delvaux N, Etienne AM, Marchal S, Meunier J, Reynaert C, Slachmuylder JL, Razavi D. Transfer of communication skills to the workplace during clinical rounds: impact of a program for residents. PLoS One. 2010 Aug 26;5(8):e12426. doi: 10.1371/journal.pone.0012426.

  PMID: 20865055 BACKGROUND

• Menard C, Merckaert I, Razavi D, Libert Y. Decision-making in oncology: a selected literature review and some recommendations for the future. Curr Opin Oncol. 2012 Jul;24(4):381-90. doi: 10.1097/CCO.0b013e328354b2f6.

  PMID: 22572724 BACKGROUND

• Merckaert I, Lienard A, Libert Y, Bragard I, Delvaux N, Etienne AM, Marchal S, Meunier J, Reynaert C, Slachmuylder JL, Razavi D. Is it possible to improve the breaking bad news skills of residents when a relative is present? A randomised study. Br J Cancer. 2013 Nov 12;109(10):2507-14. doi: 10.1038/bjc.2013.615. Epub 2013 Oct 15.

  PMID: 24129243 BACKGROUND

• Merckaert I, Libert Y, Delvaux N, Marchal S, Boniver J, Etienne AM, Klastersky J, Reynaert C, Scalliet P, Slachmuylder JL, Razavi D. Factors influencing physicians' detection of cancer patients' and relatives' distress: can a communication skills training program improve physicians' detection? Psychooncology. 2008 Mar;17(3):260-9. doi: 10.1002/pon.1233.

  PMID: 17575569 BACKGROUND

• Merckaert I, Libert Y, Delvaux N, Marchal S, Boniver J, Etienne AM, Klastersky J, Reynaert C, Scalliet P, Slachmuylder JL, Razavi D. Factors that influence physicians' detection of distress in patients with cancer: can a communication skills training program improve physicians' detection? Cancer. 2005 Jul 15;104(2):411-21. doi: 10.1002/cncr.21172.

  PMID: 15952179 BACKGROUND

• Meunier J, Merckaert I, Libert Y, Delvaux N, Etienne AM, Lienard A, Bragard I, Marchal S, Reynaert C, Slachmuylder JL, Razavi D. The effect of communication skills training on residents' physiological arousal in a breaking bad news simulated task. Patient Educ Couns. 2013 Oct;93(1):40-7. doi: 10.1016/j.pec.2013.04.020. Epub 2013 May 29.

  PMID: 23726746 BACKGROUND

• Meunier J, Libert Y, Merckaert I, Delvaux N, Etienne AM, Lienard A, Marchal S, Reynaert C, Slachmuylder JL, Razavi D. How much is residents' distress detection performance during a clinical round related to their characteristics? Patient Educ Couns. 2011 Nov;85(2):180-7. doi: 10.1016/j.pec.2010.09.022. Epub 2010 Dec 4.

  PMID: 21131159 BACKGROUND

• Razavi D, Merckaert I, Marchal S, Libert Y, Conradt S, Boniver J, Etienne AM, Fontaine O, Janne P, Klastersky J, Reynaert C, Scalliet P, Slachmuylder JL, Delvaux N. How to optimize physicians' communication skills in cancer care: results of a randomized study assessing the usefulness of posttraining consolidation workshops. J Clin Oncol. 2003 Aug 15;21(16):3141-9. doi: 10.1200/JCO.2003.08.031.

  PMID: 12915605 BACKGROUND

• Razavi D, Delvaux N, Marchal S, De Cock M, Farvacques C, Slachmuylder JL. Testing health care professionals' communication skills: the usefulness of highly emotional standardized role-playing sessions with simulators. Psychooncology. 2000 Jul-Aug;9(4):293-302. doi: 10.1002/1099-1611(200007/08)9:43.0.co;2-j.

  PMID: 10960927 BACKGROUND

• Libert Y, Peternelj L, Bragard I, Lienard A, Merckaert I, Reynaert C, Razavi D. Communication about uncertainty and hope: A randomized controlled trial assessing the efficacy of a communication skills training program for physicians caring for cancer patients. BMC Cancer. 2017 Jul 10;17(1):476. doi: 10.1186/s12885-017-3437-8.

  PMID: 28693515 DERIVED

Central Study Contacts

Yves Libert, Pr.

CONTACT

0032 2 541 34 15; yves.libert@bordet.be

Livia Peternelj, M.A.

CONTACT

0032 2 533 08 58; livia.peternelj@bordet.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 18, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2022
• Last Updated: June 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)