Satisfaction with the decision to participate in cancer clinical trials (CCT) is high, but understanding is a problem

Abstract

6067 Background: We aimed (a) to assess patient (pt) knowledge about CCT and satisfaction with decision (SWD) to participate, (b) to determine whether satisfaction correlates with objective understanding of CCT or other factors and (c) to identify correlates of increased understanding, for example with demographic data, method of giving informed consent (IC), anxiety, depression and QOL. Methods: Convenience sample of 100 pts from CCT auspiced by Cancer Trials Australia. Eligibility - signed IC, enrolment on a therapeutic CCT within the preceding week, age ≥ 18 years. Instruments assessed quality of IC (QuIC), QOL (EORTC QLQ C-30), anxiety and depression (HADS), and preferences for information and involvement in decision-making. Measures were completed within 2 weeks of clinical trial enrolment. Results: 102 pts (67 male), median age 57.9 (29–85). 27 CCT - phase I/II/III - 6/10/11. Median QuIC objective knowledge score (QuIC-A) was 77.5 (/100) and perceived (subjective) understanding (QuIC-B) 91.4. Some questions were consistently answered poorly. There was low but significant correlation between QuIC-A and B (R=0.28, p=0.004). SWD was high. Correlation between QuIC-B and SWD was moderate (0.423, p<0.001). Correlations between SWD and each of QuIC-A, anxiety (HADS-A) and depression (HADS-D) were low and not significantly different from zero. Correlation between HADS-A and HADS-D was moderately high (0.680, p<0.001). Higher objective knowledge (QuIC-A) was associated with female sex, English as a 1st language (EFL), university education and lower HADS-D scores, but not with delayed decision-making, self-assessment of global health status, phase of trial or with easier to read consent forms. Higher QuIC-B scores were associated with low-level education, EFL and higher assessment of health, but not with gender, delayed decision, HADS-D or phase of trial. Conclusions: Overall, pt knowledge regarding CCT is reasonable (and similar to published US data) and satisfaction is very high. Satisfaction is correlated with perceived, but not with objective understanding. Strategies to improve pt understanding of CCT need to be developed. No significant financial relationships to disclose.