Exploring consent to randomized placebo‐controlled clinical trials in oncology

Abstract

Randomized placebo-controlled trials are critical for advancing knowledge in oncology, yet little is known about optimal communication for informed consent. This study aimed to identify patient preferences for and satisfaction with three consultation styles (information-focused, emotion-focused and collaborative) in simulated discussions of four clinical trial concepts (randomization, placebo, tissue analysis and oncologists' recommendation). In total 75 Australian cancer patients and carers, or both, viewed videotaped simulated consultations with a doctor and patient discussing a randomized, placebo-controlled trial. Their satisfaction and preferences for both consultation style and information were assessed. The patients' characteristics and decision-making preferences were also evaluated as potential predictors for consultation style preference. Participants preferred a collaborative consultation style when discussing randomization (74.6%), placebo (71.4%) and oncologist's recommendation (77%). However an emotion-focused consultation style was preferred when discussing tissue analysis (81%). The participants represented a highly information-seeking group, although most favoured collaborative or passive roles in treatment decision-making. Limited variables were identified that predict consultation style preference. While supporting the value of a collaborative approach to clinical trial communications, the study finding that tissue analysis requires a more emotion-focused approach highlights a new focus for trial communication and confirms the need for doctors to remain flexible in their consultation style.