Efficacy of a decision aid in breast cancer patients considering immediate reconstruction: results of a randomized controlled trial

Abstract

Background: Breast cancer patients face complex decisions about immediate breast reconstruction (BR) after mastectomy. The authors evaluated the efficacy of an online decision aid in improving the decision-making process, decision quality, and health outcomes in breast cancer patients considering immediate BR. Methods: In a multicenter, randomized, controlled trial, patients were allocated to either the intervention group, receiving care as usual with access to an online decision aid, or the control group, receiving care as usual with an information leaflet. The primary outcome was decisional conflict. Secondary outcomes assessed the process of decision-making (eg, preparation for decision-making, satisfaction with information), decision quality (decision regret, knowledge), and health outcomes (eg, satisfaction with BR outcomes, body image). Patients completed questionnaires at time (T) 0 (baseline); T1 (1 week after consultation with a plastic surgeon); and T2 (3 months) and T3 (12 months) after surgery. Results: The authors included 250 patients. Decisional conflict decreased over time in both groups, with no between-group differences. Intervention participants felt better prepared for decision-making than controls (P = 0.002). At T2, 87% of intervention participants were very satisfied with the information about BR, compared with 73% of control participants (P = 0.011). No significant between-group differences were observed in any other outcome. Conclusions: The authors’ online decision aid was as effective in reducing decisional conflict as an information leaflet about immediate BR after mastectomy. However, the decision aid substantially improved the decision-making process by better preparing breast cancer patients for decisions about immediate BR.