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

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.
• Role-playing Throughout training, participants will be invited to participate in interactive role-playing with immediate and circular feed-backs [48]. Physicians will be asked to identify a clinical situation for the focus of the role-play situation. In session two to four, physicians will be asked to define a situation that would be highly uncomfortable in terms of uncertainty and hope management. In training sessions five to seven, physicians will be asked to identify clinical situations in which the transfer of learned communication skills would be difficult. Finally, in training sessions eight to ten, physicians will be asked to identify clinical situations during which the transfer of acquired skills would be uncomfortable. During role-play, the physician who reports the clinical situation will take on the role of the patient. This will allow role-play to be as realistic as possible. The small group context will promote an interactive session. During role-play, the "patient" will be exposed to the ways that he and his two colleagues are communicating in repeated rotations. During each rotation, the facilitator will suggest alternative strategies that were taught in the theoritical model and shown in the modeling video.
• Transfering to clinical practice Each training session will start with a 15-minute summary of material learned since the beginning of the training program along with a debriefing from participants of attempts to transfer the learned skills to their clinical practice. Each training session will end with a 10-minute summary of the skills learned during the session, the difficulties that may have been encountered, and a proposal for the transfer of newly learned skills to future encounters with patients.

1. Assessment Procedure The performance status, disease status and communication skills among cancer patients vary widely and as such, the use of standardized encounters with simulated patients has been recommended to assess the efficacy of CST programs designed for healthcare professionals [49]. The assessment procedure for the current study will involve the video recording of an encounter between the participating physician and a simulated advanced stage cancer patient. Participating physicians will be assessed individually. An investigator, not involved in the training program, will present each subject with questionnaires. The assessment procedure (Figure 2) will include 7 steps: (1) continuous monitoring of heart rate, (2) relaxation exercise, (3) administration of questionnaires, (4) review of the simulated cancer patient medical chart, (5) administration of the second set of questionnaires, (6) encounter with the simulated cancer patient and (7) final set of questionnaires. Perceived stress will be measured seven times throughout the assessment procedure.

5.1. Simulated Patient Encounter The simulated patient case was written by an oncologist and a psycho-oncologist at the medical oncology unit and the psycho-oncology clinic at the Jules Bordet Institute, Cancer Center of the Université Libre de Bruxelles. The simulated patient case was developed to increase physician uncertainty about predefined medico-psycho-social components and available evidence-based treatments. The simulated patient is a 36-year-old woman with advanced cancer. She is facing a third recurrence (hepatic metastasis) of a breast cancer that had previously been treated with surgery, hormone therapy, radiation therapy and chemotherapy. She has agreed to start a new chemotherapy treatment. The scenario specifies that the patient has requested a meeting with a physician to help her cope with her treatment decision. Participants will be instructed to address and respond to the concerns of the simulated patient and to take the time they need for doing that. The simulated patient will be played by an actress experienced in simulated patient encounters and will be trained to maintain a standardized script and behavior. Regular feedback sessions will be held to help the actress maintain reproducibility [50]. The simulated patient encounters will take place at the Communication Laboratory (LabComm) of the Centre de Psycho-Oncologie (Brussels, Belgium).

5.2. Psychological Assessments Participating physicians will be asked to complete a set of psychological questionnaires prior to reading the patient medical file. Data on socioprofessional characteristics, practices in oncology and sense of mastery of the communication skills needed to address uncertainty and hope with cancer patients will be collected. A second set of psychological questionnaires administered immediately prior to the encounter with the simulated patient will gather information on the perceived realism of the medical chart of the simulated patient, agreement with the treatment decision, outcome expectancies on the medical, psychological and social status of the simulated patient, perceived uncertainty and hope regarding the medical, psychological and social outcomes of the simulated patient, and psychological reactions to uncertainty regarding the medical, psychological and social outcomes of the simulated patient. Finally, a third set of psychological questionnaires will be administered immediately after meeting with the simulated patient. These questions will pertain to agreement with the treatment decision, satisfaction regarding the encounter with the simulated patient, and the sense of mastery regarding the communication skills used to address uncertainty and hope with the simulated patient. These psychological questionnaires will allow the assessment of predictors and correlates of communication skill learning used to address uncertainty and hope with the simulated patient.

5.3. Communication Assessments The encounter with the simulated patient will be video recorded and transcribed. Physician communication skills will be analyzed using three tools. The French communication content analysis software, LaComm (Centre de Psycho-Oncologie, Brussels, Belgium; http://www.lacomm.be/) analyzes verbal communication (in medicine in general and in oncology in particular) and identifies turns of speech and the type and content of speech. The explanation of how this software works has been detailed in previous publications [42, 51]. The Multidimensional analysis of Patient Outcome Predictions (MD.POP) is a reliable tool used to measure verbal expressions that address the clinical future of a patient during medical encounters. This coding system allows one to manually identify, code, and score detailed verbal content from a medical encounter transcript that addresses a patient's clinical future. The detailed MD.POP codebook is available upon request. Finally, a specific interaction-process analysis system assessing communication skills addressing hope and uncertainty will be developed for the study [52].

5.4. Physiological Assessments Throughout all assessment procedures, physician heart rate will be monitored to assess the impact of the training program on the physiological arousal associated with communication about uncertainty and hope with the simulated patient. This assessment procedure has previously been used to measure the effect of CST on the physiological arousal of residents breaking bad news in a simulated task [53].

5.5. Statistical Analyses The primary outcome of the current study is the physicians' increased communication performance after training during this encounter. A power analysis has been performed, based on a previous longitudinal study assessing physicians' communication performance composite score in an encounter with a simulated advanced-stage cancer patient (Mean = 26; SD = 8) [54]. This power analysis was conducted considering 4 independent conditions according to the time (time 1 versus time 2) and the group (experimental versus control group). As there is no previous study assessing the efficacy of an intensive communication skills training program on physicians' communication about uncertainty and hope, it was hypothesized that physicians in the control group will maintain a stable performance score from time 1 to time 2. It was also hypothesized that physicians in the experimental group will improve their performance score by 20% from time 1 to time 2. Sample size calculation has been based on an 80% power, a one-sided α = 0.05 t-test and an effect size of 0.65. Considering this power analysis, 60 evaluable physicians are therefore needed for the efficacy assessment. Considering a drop-out rate of 20%, 12 physicians should be moreover recruited (72 physicians in total). It should be recalled at this level that one trainer only will conduct the training of the experimental group. Secondary, to assess also the CST program efficacy, group-by-time effects will be performed using generalized estimating equation (GEE) on psychological, physiological and communicational assessments performed during the encounter with the simulated patient.

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