Accentuating patient values in shared decision-making: A mixed methods development of an online value clarification tool and communication training in the context of early phase clinical cancer trials.

In the shared decision-making (SDM) process for potential early phase clinical cancer trial participation, value clarification is highly recommended. However, exploration and discussion of patient values between patients and oncologists remains limited. This study aims to develop an SDM-supportive intervention, consisting of a preparatory online value clarification tool (OnVaCT) and a communication training. The OnVaCT intervention was developed and pilot-tested by combining theoretical notions on value clarification, with interview studies with patients and oncologists, focus groups with patient representatives and oncologists, and think aloud sessions with patients, following the Medical Research Council (MRC) framework for complex interventions. These human-centered methodologies enabled a user-centered approach at every step of the development process of the intervention. This study shows relevant patient values and oncologists' perspectives on value exploration and discussion in daily practice. This has been combined with theoretical considerations into the creation of characters based on real-life experiences of patients in the OnVaCT, and how the tool is combined with a communication training for oncologists to improve SDM. • Successful designing value clarification tools (VCT) requires theory-practice integration. • VCT can never be neutral, explaining bias should be obligated. • Incorporating critical deliberation is required to be able to clarify personal values. • VCT for early phase clinical trials require physicians being critical counsellors. • VCT should contain the voice of the patient, e.g. through the use of personas. [ABSTRACT FROM AUTHOR]