Satisfaction with the process of providing informed consent to cancer clinical trials

Abstract

6074 Background: Patient (pt) understanding of cancer clinical trials (CCT) is often poor. However, pt satisfaction with the informed consent process may be independent of this, as pts have variable information needs, and preferences for involvement in medical decision-making. We aimed to establish the level of pt satisfaction with the process of giving informed consent to CCT, and to determine whether satisfaction correlates with objective understanding and pt preferences. Methods: A sample of 100 pts participating in a CCT were surveyed about their: satisfaction with the consent process; level of understanding of the CCT using the Quality of Informed Consent (QuIC) questionnaire; preference for amount of information; preference for involvement in medical decision-making; depression/anxiety using the Hospital Anxiety and Depression Scale. Measures were completed within 2 weeks of CCT enrolment. Results: Analysis of the first 72 pts. Median age was 55 (29–75), 60% male, 11% were depressed and 18% anxious. 97% of pts recorded a high level of satisfaction with their decision to enrol. 84% wanted to know as much information as possible. 32% preferred that their doctor make decisions about treatment and 38% preferred joint decision-making. Pt preferences for level of involvement in decision-making were strongly associated with their perceived level of involvement in the decision (P = 0.007). 28% of pts perceived that the doctor had made the decision. No correlation was found between pt satisfaction and: objective level of understanding (R = 0.157); depression (R = -0.095); or anxiety (R = -0.069). Satisfaction was correlated with self-assessed understanding (R = 0.44; p<0.001). Pt satisfaction was higher among pts who preferred as much information as possible (P=0.045) and those who perceived having been told every possible detail (P<0.001). Conclusion: Pt satisfaction with the process of giving informed consent to CCT is very high, but does not correlate with objective understanding about the CCT. Pt preference for degree of involvement in medical decision-making is highly variable. High satisfaction coupled with suboptimal knowledge has important ethical implications. No significant financial relationships to disclose.