Financial difficulty among patients with cancer participating in clinical trials and its association with patient survival and quality of life.

BACKGROUND The incidence and worsening of financial difficulty (FD) among patients with cancer participating in clinical trials, and their relationship with mortality, quality of life (QOL), and toxicity outcomes have been understudied. The objective of this study was to understand the incidence of FD among Canadian patients participating in systemic therapy trials at baseline and after trial participation, and to assess the relationship of FD with clinical outcomes. METHODS This is a retrospective cohort study among participants of 14 systemic therapy trials conducted by the Canadian Cancer Trials Group for adult patients with advanced cancer. Incidence of FT at baseline and after trial participation were measured using EORTC QLQ-C30 questionnaire. Association of FD with trial characteristics, as well as with patient outcomes (mortality, QOL and toxicity) were studied. RESULTS Overall, 2766 patients from 14 trials were included, of which 37% had FD at baseline and 25% experienced worsening of FD after trial enrollment compared to their baseline status. Baseline FD, but not the worsening of FD, was associated with worse mortality outcomes. Worsening of FD was however associated with poor global QOL outcomes and increased odds of clinical toxicities. CONCLUSIONS Even in the setting of a public health system of Canada, one third patients experience FD, with a quarter of them experiencing worsening of FD with trial participation, and both were related to worse patient outcomes. Targeted policy level interventions are needed to understand and address the cause for FD in patients with cancer.