Centre for Psycho-Oncological Research and Training, Department of Community Medicine and Unit for Behavioural Sciences, School of Public Health, The University of Hong Kong, 5/F, WMW Mong Block, Faculty of Medicine Building, 21 Sassoon Rd, Pokfulam, Hong Kong; Special Administrative Region, People's Republic of China.
J Clin Oncol. 2013 Aug 10;31(23):2879-85. doi: 10.1200/JCO.2012.45.1856. Epub 2013 Jul 8.
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.
乳腺癌（BC）决策辅助（DA）随机研究仅限于在西方人群的咨询中使用 DA 进行原发性手术。其在咨询之外、用于重建手术和其他人群中的有效性尚未得到评估。我们开发了一种 DA，在咨询后用于决定接受 BC 手术的中国女性，以及在相关情况下立即进行乳房重建，这在这项随机对照试验（RCT）中进行了评估。
共有 276 名患有早期 BC 并考虑接受 BC 手术的女性被随机分配接受 DA（带回家的小册子）或标准信息小册子（对照条件），在初始咨询中，外科医生向患者透露诊断并讨论治疗方案。通过按周进行块随机分组，138 名女性被分配到 DA 组，138 名女性被分配到对照组。参与者在咨询后 1 周完成基于访谈的问卷，然后在手术后 1、4 和 10 个月进行随访。主要结局测量指标是决策冲突、决策困难、咨询后 1 周的 BC 知识和手术后 1 个月的决策后悔。次要结局测量指标是治疗决策、手术后 4 个月和 10 个月的决策后悔、手术后焦虑和抑郁。
与对照组相比，接受 DA 的女性在咨询后 1 周报告的决策冲突评分显著降低（P =.016）。接受 DA 的女性在手术后 4 个月（P =.026）和 10 个月（P =.014）的决策后悔评分显著降低，并且在手术后 10 个月的抑郁评分也显著降低（P =.001）。
这项 RCT 表明，DA 可能通过减少决策冲突和随后的后悔，使香港的中国患者受益，并为该人群提供更好的临床服务。
