Patient Values in Patient-Provider Communication about Participation in Early Phase Clinical Cancer Trials: a Qualitative Analysis before and after Implementation of an Online Value Clarification Tool Intervention

Background: Patients with advanced cancer who have no standard treatment options anymore can sometimes decide to participate in early phase clinical trials (i.e. experimental treatments with uncertain outcomes). Shared decision-making models consider discussing patient values essential, but such communication is often limited in this context and may require new interventions. Correspondingly, the OnVaCT intervention was previously developed consisting of a preparatory online value clarification tool (OnVaCT) for patients and communication training for oncologists. This study aimed to qualitatively explore which and how patient values are discussed (in context with each other) between patients and oncologists during consultations about potential early phase clinical trial participation before and after implementation of the OnVaCT intervention. Methods This study had a between-subjects design: pre-test patients received usual care, while post-test patients additionally received the OnVaCT. Oncologists participated in the communication training between study phases. Patients’ initial consultation on potential early phase clinical trial participation was recorded and transcribed verbatim. Applying a directed approach, two independent coders analysed the transcripts using an initial codebook based on previous studies. Steps of continuous evaluation and revision were repeated until data saturation was reached. Results Data saturation was reached after 32 patient-oncologist consultations (i.e. 17 pre-test and 15 post-test). These revealed the values hope, perseverance, quality or quantity of life, risk tolerance, trust in the healthcare system/professionals, autonomy, social adherence, altruism, corporeality, accepting one’s fate, and humanity. Pre-test patients mostly expressed values shortly and spontaneously, e.g. while responding to information. Oncologists acknowledged the importance of patient values, but generally only described ‘opposite’ examples why some accept and others decline trial participation, without asking further questions. In the post-test, many oncologists referred to the OnVaCT and/or asked probing questions, while patients used longer phrases connecting multiple values. Conclusions While all values could be recognized in both study phases, our analysis has pointed to the different patterns surrounding patient values in communication on potential early phase clinical trial participation before and after implementation of the OnVaCT intervention. This study thereby suggests that the OnVaCT intervention may support patients and oncologists in discussing their values. Trial registration Netherlands Trial Registry: NL7335, registered on July 17, 2018