Seeking informed consent to cancer clinical trials; evaluating the efficacy of doctor communication skills training

Introduction: Clinical trials have come to be regarded as the gold standard for treatment evaluation. However, many doctors and their patients experience difficulties when discussing trial participation, leading to poor accrual to trials and questionable quality of informed consent. We have previously developed a communication skills training program based on a typology for ethical communication about Phase II and III clinical trials within four categories. The training program consisted of a 1 day experiential workshop that included didactic teaching, exemplary video and role play. The aim of this study was to evaluate the effectiveness of the communication skills training workshop. Method. Oncologists were recruited from three major teaching hospitals conducting oncology outpatient clinics in three Australian capital cities. Ten oncologists and 90 of their adult cancer patients who were eligible for a Phase II or III clinical trial participated. Ninety informed consent consultations were audiotaped before (n = 59) and after (n = 31) training, and fully transcribed. The presence or absence of each domain component was coded and these were summed within categories. A coding manual was produced which enabled standardization of the coding procedure. Patients completed questionnaires before and after the consultation, and doctors completed a short measure of satisfaction after the consultation. Results: Doctors increased their use of some aspects of shared decision-making behavior (t(87) = - 1.945, p = 0.05) and described some aspects of essential ethical/clinical information more commonly. In addition they used less coercive behaviors (z = -1.976, p = 0.048). However, they did not provide more clinical information or structure their consultations in the recommended fashion. Patients in the post-training cohort reported more positive attitudes to clinical trials, but other outcomes were not affected by the intervention. Conclusions: This short training programme demonstrated limited success in improving the oncologist's communication skills when gaining informed consent. A larger randomized trolled trial of extended training is now underway. Copyright (c) 2006 John Wiley & Sons, Ltd.