Decisional Conflict after Deciding on Potential Participation in Early Phase Clinical Cancer Trials: Dependent on Global Health Status, Satisfaction with Communication, and Timing.

Abstract

Simple SummaryEarly phase clinical trials are an essential part of modern drug development and thus the advance of anti-cancer therapies for patients. However, deciding whether to participate in such trials can be complex and patients have reported decisional conflict (i.e., unresolved decisional needs). The aim of our study was to untangle several factors that contribute to decisional conflict in patients with advanced cancer who have recently been asked to decide whether to participate in early phase clinical trials. We found that patients experienced less decisional conflict if they had a better global health status, higher satisfaction, and made their decision sooner. Other factors, such as the decision to (not) participate, did not prove to be the best indicators for decisional conflict. With these insights, we can start to build hypotheses on how to improve the decision-making process for patients with end-stage cancer, which can ultimately improve their quality of life.When standard treatment options are not available anymore, patients with advanced cancer may participate in early phase clinical trials. Improving this complex decision-making process may improve their quality of life. Therefore, this prospective multicenter study with questionnaires untangles several contributing factors to decisional conflict (which reflects the quality of decision-making) in patients with advanced cancer who recently decided upon early phase clinical trial participation (phase I or I/II). We hypothesized that health-related quality of life, health literacy, sense of hope, satisfaction with the consultation, timing of the decision, and the decision explain decisional conflict. Mean decisional conflict in 116 patients was 30.0 (SD = 16.9). Multivariate regression analysis showed that less decisional conflict was reported by patients with better global health status (β = −0.185, p = 0.018), higher satisfaction (β = −0.246, p = 0.002), and who made the decision before (β = −0.543, p < 0.001) or within a week after the consultation (β = −0.427, p < 0.001). These variables explained 37% of the variance in decisional conflict. Healthcare professionals should realize that patients with lower global health status and who need more time to decide may require additional support. Although altering such patient intrinsic characteristics is difficult, oncologists can impact the satisfaction with the consultation. Future research should verify whether effective patient-centered communication could prevent decisional conflict.