Reducing Treatment Decision Conflict Difficulties in Breast Cancer Surgery: A Randomized Controlled Trial

Abstract

Breast cancer (BC) decision aid (DA) randomized studies are limited to DA use in consultations among Western populations and for primary surgery. Their effectiveness beyond consultations, for reconstructive surgery and in other populations, has not been evaluated. We developed a DA administered after consultation for Chinese women deciding on BC surgery and, where relevant, immediate breast reconstruction, which was evaluated in this randomized controlled trial (RCT). Overall, 276 women considering BC surgery for early-stage BC were randomly assigned to receive a DA (take-home booklet) or the standard information booklet (control condition) after the initial consultation, wherein surgeons disclosed the diagnosis and discussed treatment options with patients. Using block random assignment by week, 138 women were assigned to the DA arm and 138 to the control arm. Participants completed interview-based questionnaires 1 week after consultation and then 1, 4, and 10 months after surgery. Primary outcome measures were decisional conflict, decision-making difficulties, BC knowledge 1 week after consultation, and decision regret 1 month after surgery. Secondary outcome measures were treatment decision, decision regret 4 and 10 months after surgery, and postsurgical anxiety and depression. The DA group reported significantly lower decisional conflict scores 1 week after consultation (P = .016) compared with women in the control arm. Women receiving the DA had significantly lower decision regret scores 4 (P = .026) and 10 months (P = .014) after surgery and lower depression scores 10 months after surgery (P = .001). This RCT demonstrated DAs may benefit Chinese patients in Hong Kong by reducing decisional conflict and subsequent regret and enhance clinical services for this population.