跳至主要内容
临床试验/NCT02836197
NCT02836197Unknown不适用

Communication About Uncertainty and Hope: A Randomized Controlled Trial Assessing the Efficacy of a Communication Skills Training Program for Physicians Caring for Cancer Patients

Jules Bordet Institute2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
72
试验地点
2
主要终点
Physicians' acquisition of communication skills addressing uncertainty and hope in encounters with a simulated advanced stage cancer patient through validated tools and questionnaires

研究概览

简要总结

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.

详细描述

  1. Aim of the trial A randomized longitudinal study assessing the efficacy of a CST program aimed at improving physician communication about uncertainty and hope with cancer patients will be conducted. Efficacy of the program will be assessed by the analysis of changes over time in physician communication skills and physician psychological and physiological health. These assessments will be performed in the context of an encounter with a simulated advanced-stage cancer patient.
  2. Subjects Participants will be physicians that are specialists or residents, have a practice including cancer patients and speak French. The study was approved by a central ethics committee (Jules Bordet Institute, Cancer Center of the Université Libre de Bruxelles) and all participants will provide written informed consent.
  3. Study Design Participating physicians will be randomly assigned to either the experimental group or the control group (Figure 1). After baseline assessment, participants in the experimental group will attend a 4-month training program followed by a post assessment. Participants in the control group will be placed on a training program waitlist after baseline assessment and will be reassessed four to five months later. The process of randomization after baseline will allow for a double-blind assessment at baseline.
  4. CST Program 4.1. CST aims The aim of the CST is to improve the ability of physicians to communicate about uncertainty and hope with cancer patients.

4.2. CST logistics The CST is a manualized program comprised of ten 3-hour sessions (30 hours) spread over four to five months. Each training group will include three physicians. The training will be conducted at locations and times choosen by the physicians within each group. The trainer of the experimental group will be an experienced facilitator who will conduct all training sessions (Y.L.). The training timetable will not include more than two 3-hours sessions in one day. Physicians will have the opportunity to register in groups of three or individually. In the latter case, physicians will be assigned to groups according to geographical proximity.

4.3. CST Sessions The first session of the training program will include a general introduction to training and a modeling session. Sessions two to four will focus on appropriate communication skills for addressing uncertainty and hope according to a model detailed in a training manual. During sessions five to seven, participants will learn to transfer their newly-learned skills to clinical practice. Finally, during sessions eight to ten, skills learned during the training program will be consolidated.

4.4. CST Program The CST program will include theoretical information giving about uncertainty and hope in cancer care (based on psychodynamics, cognitive-behavioral and systemic theories), modeling and role-playing.

  • Theoretical information giving The CST trainer will provide theoretical information on communication skills needed to address uncertainty and hope in encounters with cancer patients. These skills will focus on assessing patient expectations about the future and restructuring patient understandings with appropriate information when needed; and assessing patient hopes about the future and supporting those which are realistic [47]. All skills will be based on a collaborative and bidirectional communication process between physicians and patients on topics such as disease prognosis or expected and unexpected medical, psychological and social effects of cancer treatments. A specific algorithmic theoretical model has been designed to aid physicians in the implementation of these communication skills.
  • Modeling During the first CST session, physicians will observe a 16-minute video of a simulated interview in which the trainer acts as a physician communicating with a patient suffering from advanced cervical cancer. In the scenario, the patient has come for chemotherapy treatment and is requesting reassurance about treatment efficacy.

The modeling session will empahsize three factors: 1) physician attitudes necessary to address uncertainty and hope, 2) patient's reactions to the discussion of uncertainty and hope and 3) the need to set up a safe and comfortable setting in which to model communication skills needed to address uncertainty and hope. After the video, physicians will be given one hour to debrief and react to the simulated interview.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Communication skills training (Behavioral)

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.

结局指标

主要结局

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

时间窗: 4 months

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yves Libert

Professor

Jules Bordet Institute

研究点 (2)

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