Abstract P5-09-01: Improving Informed Consent: Evaluating the First Decision Aid in a Clinical Trial Setting (IBIS-II Breast Cancer Prevention Trial)

Abstract

Abstract Background: Recruitment to clinical trials is generally suboptimal, with both patients/consumers and clinicians reporting difficulties with the consent process. Decision Aids (DAs) are designed to facilitate doctor-patient communication and participation in decision-making, and may improve the consent process by ensuring patients/consumers make decisions that are informed and acted upon. While participant information sheets (PIS) provide information about the specific clinical trial, DAs present evidence-based information about all available management options (not just the clinical trial), including risks and benefits of each option. They also present both written and graphical forms of the information to enhance understanding, and explicit value clarification exercises to facilitate value-sensitive decisions. In screening and treatment settings, DAs have been found to reduce decisional conflict, improve patient knowledge, create more realistic expectations, and promote active decision-making without increasing anxiety. This RCT aimed to evaluate the efficacy of a DA for women at increased risk of breast cancer who are considering participation in the IBIS-II Prevention trial. Methods: Women eligible for IBIS-II, who had not decided about participation, were invited to take part in the DA study. Participants from 12 Australian and New Zealand IBIS-II centres were randomised to receive either the standard IBIS-II information and consent materials alone (Control group, n=89), or in combination with a DA booklet (DA group, n=89). Participants completed standardised and purpose-designedmeasures 1 week and 3 months after deciding whether or not to participate in IBIS-II. Results: In the Prevention arm, the majority of women (84%) reported the DA made it easier to understand IBIS-II compared to reading the PIS alone, and 89% recommended providing both the DA and PIS to potential IBIS-II participants. No group differences were detected in levels of decisional conflict or knowledge of IBIS-II/clinical trials in general, due to floor and ceiling effects respectively. Similarly, no group differences were found in levels of decisional regret and satisfaction at 3-month follow-up. Discussion: This is the first study to assess the effectiveness of DAs in a clinical trial setting. The use of DAs has been strongly endorsed by participating women and clinicians. Challenges of evaluating DAs in a Prevention breast cancer trial setting will be discussed. An RCT of a DA for the DCIS arm of IBIS-II is currently underway. The DAs have the potential to enhance the process of informed consent and reduce dropout rates in clinical trials. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-09-01.