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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
Sponsor:
Collaborators:
Université Libre de Bruxelles
Université Catholique de Louvain
Université de Liège
Centre de Psycho-Oncologie (CPO)
Information provided by (Responsible Party):
Yves Libert, Jules Bordet Institute

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.


Condition or disease Intervention/treatment Phase
Physician Patient Relationship Behavioral: Communication skills training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Yves Libert, Pr. 0032 2 541 34 15 yves.libert@bordet.be
Contact: Livia Peternelj, M.A. 0032 2 533 08 58 livia.peternelj@bordet.be

Locations
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Belgium
Libert Yves Recruiting
Brussels, Belgium, 1000
Contact: Livia Peternelj    474897965    liviapeternelj@hotmail.com   
Principal Investigator: yves libert         
Libert Not yet recruiting
Brussels, Belgium, 1000
Contact: Livia Peternelj, M.A.    ++ 32 474897965    liviapeternelj@hotmail.com   
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         
Sponsors and Collaborators
Jules Bordet Institute
Université Libre de Bruxelles
Université Catholique de Louvain
Université de Liège
Centre de Psycho-Oncologie (CPO)
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yves Libert, Professor, Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT02836197    
Other Study ID Numbers: CERTAIN
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yves Libert, Jules Bordet Institute:
Uncertainty;hope;cancer;communication skills training;physicians