Study protocol: Randomized controlled trial of web-based decision support tools for high-risk women and healthcare providers to increase breast cancer chemoprevention
Study protocol: Randomized controlled trial of web-based decision support tools for high-risk women and healthcare providers to increase breast cancer chemoprevention
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DOI：
10.1016/j.conctc.2019.100433
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发表时间：
2019-12-01
影响因子：
1.5
通讯作者：
Kukafka, Rita
中科院分区：
文献类型：
--
作者：
Crew, Katherine D.;Silverman, Thomas B.;Kukafka, Rita
背景：使用选择性雌激素受体调节剂和芳香酶抑制剂进行化学预防已被证明可以降低高危女性的浸润性乳腺癌发病率。尽管有这些证据，但很少有符合化学预防条件的高危女性将其作为降低风险的策略。低采用率的原因包括患者和医疗保健提供者对化学预防知识不足、对副作用的担忧、临床遇到的时间限制以及竞争性合并症。方法/设计：我们描述了一项随机对照试验的研究设计，该试验检查两种基于网络的决策支持工具对化学预防决策前因和质量的影响、转诊专门咨询以及乳腺癌风险增加的女性对化学预防的采用。该试验正在一家大型城市医疗中心进行。将招募总共 300 名患者和 50 名医疗保健提供者，并随机分配标准教育材料单独使用或与决策支持工具结合使用。患者报告的结果将在基线、随机化后 1 个月和 6 个月以及与医疗保健提供者进行诊所就诊后进行评估。讨论：我们正在进行这项试验，以提供证据，说明如何最好地支持个性化乳腺癌风险评估以及化学预防的知情和共享决策。我们建议将决策支持工具整合到临床工作流程中，这有可能扩大高质量决策和化学预防的采用。
Background: Chemoprevention using selective estrogen receptor modulators and aromatase inhibitors has been shown to reduce invasive breast cancer incidence in high-risk women. Despite this evidence, few high-risk women who are eligible for chemoprevention utilize it as a risk-reducing strategy. Reasons for low uptake include inadequate knowledge about chemoprevention among patients and healthcare providers, concerns about side effects, time constraints during the clinical encounter, and competing comorbidities.Methods/design: We describe the study design of a randomized controlled trial examining the effect of two web-based decision support tools on chemoprevention decision antecedents and quality, referral for specialized counseling, and chemoprevention uptake among women at an increased risk for breast cancer. The trial is being conducted at a large, urban medical center. A total of 300 patients and 50 healthcare providers will be recruited and randomized to standard educational materials alone or in combination with the decision support tools. Patient reported outcomes will be assessed at baseline, one and six months after randomization, and after their clinic visit with their healthcare provider.Discussion: We are conducting this trial to provide evidence on how best to support personalized breast cancer risk assessment and informed and shared decision-making for chemoprevention. We propose to integrate the decision support tools into clinical workflow, which can potentially expand quality decision-making and chemoprevention uptake.