Primary outcomes analysis of a multicenter randomized controlled trial of an interactive decision tool for patients with breast cancer.

Abstract

6500 Background: High quality treatment decisions require that patients are well informed about treatment and that their values are considered. Yet studies show that patient knowledge about breast cancer treatment trade-offs is low and appraisal of decision-making is not optimal. Methods: We conducted a randomized controlled trial (RCT) of a tailored, comprehensive (locoregional and systemic treatment) and interactive decision tool (iCanDecide), compared with static online information. 537 newly diagnosed, early stage breast cancer patients were enrolled at the first visit in 22 surgical practices. Participants were surveyed 5 weeks (N = 496; RR 92%) post enrollment after locoregional treatment decision-making. The primary outcome was a high quality decision, including two components: high knowledge about treatment options and a values concordant treatment decision. The main secondary outcome was preparation for decision making. We evaluated the distribution of participants in each arm, and conducted logistic regression modeling to assess the association between the intervention and the outcomes controlling for patient characteristics and strength of treatment preference at enrollment. Results: Significantly more intervention than control patients had high knowledge (60% vs. 42%, p < 0.001), although the majority of both groups reported values concordant treatment (~84%). Intervention patients also reported feeling prepared for decision making significantly more often than controls (45% vs. 32%, P < 0.01). Patients randomized to the interactive intervention had higher knowledge (OR: 2.2; 95% CI 1.2-4.0) and preparation for decision making (OR: 1.5; 95% CI 1.1-1.4), even after adjusting for age, education, race, stage and clinical site. Conclusions: In this large RCT, a tailored, interactive treatment decision tool for breast cancer improved knowledge and prepared patients for complicated decision making, more than access to static online information. Future work to further integrate such tools into the clinical workflow is needed. Clinical trial information: NCT01840163.