Highlights

Interactive workshop on how to talk to patients about advanced disease and clinical trial enrollment promotes realistic expectations and truly informed consent for early phase trials.

Why this item may be useful

The authors describe the results of an intensive, evidence-based workshop designed for health care providers (HCP) involved with early-phase clinical trials. The workshop was successful in improving communication skills, increasing HCP confidence, and ensuring valid and ethical consent. Participants worked with facilitators and actors (referred to as patient simulators) who role-played as cancer patients, covering a wide range of trials, tumor sites, and patient characteristics. Analyses of audio tapes showed that the providers improved their ability to confirm the patient's knowledge of their prognosis, to discuss symptomatic care, to convey the aims of the trial and the unlikelihood of medical benefit. Overall, patient simulators improved their understanding of information required to elicit ethical consent.

Details

• Participants were managers of phase I trial units in the United Kingdom.
• During eight hours over two days, workshop participants received didactic instruction and facilitated discussions based on DVD-based scenarios. 
• Patient simulator ratings showed improvements in: awareness of palliative care and symptom control, the voluntariness of participation, the opportunity to ask questions, and the time to consider participation.