Randomized Controlled Trial Assessing the Efficacy of a Communication Skills Training Program (CERTAIN)
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|ClinicalTrials.gov Identifier: NCT02836197|
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : June 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Physician Patient Relationship||Behavioral: Communication skills training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Communication About Uncertainty and Hope: A Randomized Controlled Trial Assessing the Efficacy of a Communication Skills Training Program for Physicians Caring for Cancer Patients|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2022|
Experimental: Experimental group
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
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.
No Intervention: Waiting-list group
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.
- Physicians' acquisition of communication skills addressing uncertainty and hope in encounters with a simulated advanced stage cancer patient through validated tools and questionnaires [ Time Frame: 4 months ]
- Improvement in physicians satisfaction regarding their communication skills addressing uncertainty and hope in encounters with a simulated advanced stage cancer patient through a questionnaire [ Time Frame: 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836197
|Contact: Yves Libert, Pr.||0032 2 541 34 email@example.com|
|Contact: Livia Peternelj, M.A.||0032 2 533 08 firstname.lastname@example.org|
|Brussels, Belgium, 1000|
|Contact: Livia Peternelj 474897965 email@example.com|
|Principal Investigator: yves libert|
|Libert||Not yet recruiting|
|Brussels, Belgium, 1000|
|Contact: Livia Peternelj, M.A. ++ 32 474897965 firstname.lastname@example.org|
|Contact: Isabelle Merckaert, Pr. ++ 32 478 84 35 02|
|Principal Investigator: Yves Libert|
|Sub-Investigator: Darius Razavi|
|Sub-Investigator: Christine Reynaert|
|Sub-Investigator: Isabelle Bragard|
|Sub-Investigator: Isabelle Merckaert|
|Sub-Investigator: Livia Peternelj|