Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

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

Summary: Today, oncological care offers more effective and personalized treatments than ever before, while cancer patients and their physicians are increasingly confronted with uncertainty. Physicians may experience a lot of difficulties to simultaneously address this uncertainty with their cancer patients and to support their hope. Although previous studies reported the effectiveness of communication skills training designed for health care professionals (CST), specific training addressing uncertainty and hope in oncology have not yet been studied. This project aims to assess in a randomized study the efficacy of a 30-hour CST program addressing uncertainty and hope in oncology and designed for physicians. The efficacy will be assessed by analyzing physicians' acquisition of communication skills addressing uncertainty and hope in encounters with a simulated advanced stage cancer patient.

Detailed description: 1. Aims of the study Starting from studies addressing the effectiveness of communication skills training program in oncology, the current project aims to conduct a randomized longitudinal study to assess the efficacy of an intensive communication skills training program addressing uncertainty and hope in oncology and designed for physicians. This efficacy will be assessed by analyzing physicians' acquisition of communication skills addressing uncertainty and hope in encounters with a simulated advanced stage cancer patient through validated tools and questionnaires.
  2. State of the art In the last decades, major developments have been achieved in oncological care. Cancer patients and their families are now confronted with various treatments, including a personalized approach and involving multidisciplinary care. These developments allowed getting cancer the status of a chronical disease, putting numerous patients in a course alternating between treatment phases and remission phases. Numerous cancer patients are also confronted to long term treatments aiming to control an advanced disease. These developments support the patients' and physicians' hope for an increased life-expectancy. At the same time, they lead them to frequently face contexts of high uncertainty regarding their prognosis or the expected and unexpected effects of cancer treatments. Although these contexts are complex in terms of communication, no studies has yet been conducted to assess the efficacy of a communication training program addressing specifically uncertainty and hope in oncology and designed for physicians.
  3. Study protocol
  3.1. Subjects To be included in this study, physicians have to speak French and have to be willing to participate in the research program. The physicians (n=72) included are oncologists, other specialists, and residents with at least one year of experience working with cancer patients (part-time or full-time). Recruitment has given priority to physicians working at Jules Bordet Institute. The local ethics committee approved this study and all of the participants provided written informed consent.
  3.2. Study design Participating physicians will be randomized in two groups. The first group of 36 physicians will immediately attend the training program (experimental group). The second group of 36 physicians will attend the training in a delayed manner (control group). Comparison between the experimental group and the control group will allow highlighting the impact of the training on communicational, physiological and psychological variables recorded in the context of an encounter with a simulated advanced stage cancer patient. For the experimental group, the first recording will take place before the first training session and the second recording after the last session. For the control group, the first and the second recording will take place with a four-month interval.
  3.3. Communication skills training program The general aim of the training program is to help physicians learn effective communication skills in contexts of high uncertainty. The specific aims of the training program are to help physicians to talk about uncertainty with their cancer patients and to support their hope; to improve general physicians' communication's skills; to optimize physician/patient relationship; to help patients to better cope with uncertainty; to increase physicians' consciousness regarding their own reactions to uncertainty. The training will last 30 hours, will be spread over 4 months. This program involves 10 3-hours sessions scheduled according the participants wishes. To increase training accessibility to physicians and facilitate participation, 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. The communication skills taught are based on psychodynamics, cognitive-behavioral and systemic theories. The training staff is highly specialized in caregiver/patient communication training programs in oncology (Y. Libert and S. Marchal).
  3.4. Assessment procedure In cancer care, patients' performance status, disease status and their communication behaviors can widely vary. To reduce these variabilities, the use of standardized simulated patient encounters has been recommended to assess the efficacy of communication skills training programs designed for health care professionals. The assessment procedure of the current study involves the recording of an encounter with a simulated advanced stage cancer patient. For the experimental group, the first recording will take place before the first training session and the second recording after the last session. For the control group, the first and the second recording will take place with a four months' interval. Participating physicians will be assessed individually. An investigator, who will not be involved in the training program, will present every subject with self-assessment scales and experimental tasks associated with this recording. The assessment procedure includes 6 steps: a relaxation exercise, a first completion of a set of psychological questionnaires, the reading of the simulated patient medical file, a second completion of a set of psychological questionnaires, the conduction of the simulated encounter, and a third completion of a set of psychological questionnaires,.
  3.4.1. Simulated patient encounter The simulated case was created by the medical oncology unit and the psycho-oncology clinic of our cancer center (Jules Bordet Institute, Brussels, Belgium). This simulated case was developed in order to increase physicians' uncertainty about medico-psycho-social components and available evidence-based treatments. The simulated patient chosen for this study is a 36-year-old woman with advanced cancer. She is facing a third recurrence (hepatic metastasis) of breast cancer that had previously been treated with surgery, hormone therapy, radiation therapy and chemotherapy. She decided to start a new chemotherapy treatment in a near future. For the assessment procedure, physicians will be instructed that she asked to meet a physician in order to help them better cope with this therapeutic decision. During the encounter, physicians are instructed to address concerns of the simulated patient, to maintain their professional identity and to take the time they need. The simulated patient is played by an actress experienced in simulated patient encounters. She has been trained to maintain standardized script and behaviors for each encounter. Regular feedback sessions will be organized to help the actress maintain reproducibility. During the simulated patient encounter, the actress was instructed to explicitly express four concerns: her fear of death in a near future; her fear that the chemotherapy that she will start soon will not be effective regarding the disease progression; her fear to suffer from a major depression relapse; and a general fear to be less available for her children in the next weeks. She will be instructed to express a moderate anxiety about each concern. The simulated patient encounters will be organized in the communication lab of the Centre de Psycho-Oncologie (Brussels).
  3.4.2. Psychological questionnaires Participating physicians will be asked to fill in a first set of psychological questionnaires before reading the simulated patient medical file: perceived mastery of communication skills addressing hope and uncertainty in oncology (specific questionnaire); and perceived stress (Visual Analogic Scale).
  Participating physicians will be asked to fill in a second set of psychological questionnaires immediately before conducting the simulated encounter: perceived stress (Visual Analogic Scale); agreement with the therapeutic decision recorded in the simulated patient medical file (specific questionnaire); perceived realism of information recorded in the simulated patient medical file (specific questionnaire); self-efficacy and perceived outcome expectancies regarding communication skills addressing uncertainty and hope that they could use when conducting the simulated encounter (specific questionnaire); and perceived stress (Visual Analogic Scale).
  Finally, participating physicians will be asked to fill in a third set of psychological questionnaires immediately after conducting the simulated encounter: perceived stress (Visual Analogic Scale); satisfaction with their communication performance during the encounter (specific questionnaire); perceived mastery regarding communication skills addressing uncertainty and hope that they used when conducting the simulated encounter (specific questionnaire); and perceived stress (Visual Analogic Scale).
  3.4.3. Communication content analyses The simulated encounter will be audio recorded and transcribed. Physicians' communication skills will be analyzed using three tools. A French communication content analysis software, LaComm (Centre de Psycho-Oncologie, Brussels, Belgium; http://www.lacomm.be/) which is a software that analyzes verbal communication (in medicine in general and in oncology in particular) utterance by utterance and identifies turns of speech and the type and content of utterances. The explanation of how this software works has been detailed in a previous publication. The Multidimensional analysis of Patient Outcome Predictions (MD.POP) which 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 informs about the 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.
  3.4.4. Physiological assessment Throughout all the assessment procedure, physicians' heart rate will be recorded in order to assess the impact of the training program on the physiological arousal associated with their ways of addressing uncertainty and hope with the simulated patient. This recording procedure has been previously used to assess the effect of communication skills training on residents' physiological arousal in a breaking bad news simulated task.
  3.5. Data sample and data analyses Training efficacy will be assessed with a higher frequency of facilitating communication strategies addressing hope and uncertainty (about 10%), used by participating physicians during the simulated encounter, a better definition of behavioral intentions and a higher physicians' satisfaction about their decisions during the encounter. A 72 assessable physicians sample would bring enough statistical power to detect this difference. To evaluate the training effect, group-by-time effects will be assessed using generalized estimating equation (GEE) regression models. Dependent variables will be identified as normal, binomial, Poisson, or binomial negative distributions as appropriate. All tests will be two-tailed, and alpha will be set at 0.05.

Eligibility: 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.

Relevance to patient case: not relevant