Improving Shared Decision-Making in Early Phase Clinical Trials and Palliative Care: A Prospective Study on the Impact of an Online Value Clarification Tool Intervention

Objectives: This study evaluated the impact of the OnVaCT intervention, a narrative-based Online Value Clarification Tool (OnVaCT), combined with communication training for oncologists, on shared decision-making (SDM) in discussions on potential early phase clinical trial participation and palliative care. These high-stakes decisions often challenge patients and oncologists in addressing patient values, a crucial component of SDM. We hypothesized that the intervention would improve oncologist-patient communication, specifically SDM application, and (consequently) reduce patient decisional conflict. Methods: In this prospective, multicentre pre-post clinical study, patients completed two surveys, and their recorded consultations on early phase clinical trials and palliative care were assessed by independent coders. Pre-intervention patients received usual care, while post-intervention patients used the OnVaCT. Oncologists underwent communication training between study phases. Endpoints included decisional conflict (primary), the extent to which oncologists, patients and relatives participate in SDM, consultation length, and patient decisions (secondary). Results: Decisional conflict (p = 0.394) did not differ between pre-test (n = 116, M = 30.0, SD = 16.9) and post-test (n = 99, M = 29.4, SD = 15.2). Oncologists significantly increased their SDM application post-intervention (p < 0.001; n = 129, M = 38.5, SD = 12.6) compared to pre-intervention (n = 163, M = 28.8, SD = 9.2), particularly when the OnVaCT was discussed. Other outcomes, including consultation length, remained stable. Conclusions: The OnVaCT intervention enhanced SDM and supported value-based discussions, without prolonging consultations. Further research should explore whether additional implementation efforts could reduce decisional conflict and the intervention's potential impact on other patient-centred outcomes. Some decisions, however, may inherently involve unresolved conflict.