What predicts patient (pt) understanding regarding cancer clinical trials (CCT)

Abstract

6107 Background: We aimed (a) to assess how well pts newly enrolled on CCT understand the trials and (b) to identify correlates of increased understanding, for example with demographic data, method of giving informed consent (IC), preference re information and decision-making, anxiety, depression and QOL. Methods: Convenience sample of 100 pts from CCT auspiced by CTA. Eligibility -signed IC, enrolment on a therapeutic CCT within the preceding week, ability to complete English versions of the pt-completed measures, age ≥ 18 years. Instruments assessed quality of IC (QuIC), QOL (EORTC QLQ C-30), anxiety and depression (HADS), and preferences for information (Cassileth information styles questionnaire). Results: Data are available for the first 72 pts: 60% male, median age 56 (29–75). Median QuIC objective knowledge score (QuIC-A) was 76.9. Some questions were answered poorly (see table). Median perceived (subjective) understanding (QuIC-B) was 94.6. There was low but significant (sig) correlation between QuIC-A and B (R=0.28, p=0.018). Variation in QuIC-B was associated with English as a first language (EFL), reading the consent form (CF) carefully, an ‘easy to read’ CF and overall satisfaction with consent process (all sig at p=0.05). There was low, but sig correlation between QuIC-B and age (R=0.28, p=0.019). Regarding highest level of education (HLE), both low and possibly high HLE were associated with higher QuIC-B scores. Higher knowledge score (QuIC-A) was associated with EFL (p=0.05) and possibly with overall QOL (p=0.09). No correlation was found between QuIC-A or -B and either depression or anxiety. Conclusions: Overall pt knowledge regarding CCT is reasonable. Deficiencies about particular aspects of trials merit further attention. Improved objective (QuIC-A) and subjective (QuIC-B) knowledge are associated with speaking EFL. QuIC-B is associated with additional factors. No significant financial relationships to disclose.