Multicenter trial of decision support for breast cancer chemoprevention

选择性雌激素受体调节剂和芳香化酶对乳腺癌的化学预防作用 尽管几项随机对照试验表明， 在高危妇女中的乳腺癌发病率。患有不典型增生（AH）或小叶癌的女性 原位（LCIS）乳腺癌风险增加了4- 10倍，相对风险降低了70- 80 与SERMs或AI。化学预防摄取率低的原因包括咨询时间不足， 关于SERMs和AI的知识，以及对副作用的担忧。我们假设标准教育 材料结合决策支持工具将增加化学预防知情选择相比， 在患有AH或LCIS的妇女中仅使用标准教材。 我们开发了基于网络的决策支持工具，高风险妇女的RealRisks和BNAV（乳腺癌） 癌症风险导航工具）。我们以患者为中心的决策辅助工具RealRisks可用 在不同健康素养的多种族高风险妇女中进行了严格测试， 计算能力和文化适应能力。在接触这些工具后，我们已经证明了准确性的提高。 多民族高危人群的乳腺癌风险认知、化学预防知识和知情选择 妇女我们的目标是通过电子健康记录（EHR）将这些工具集成到诊所工作流程中， 扩大其在针对AH或LCIS女性的多中心试验中的使用。评价有效性（目标1）， 实施（目标2），我们将在40个标准教育中心进行一项混合聚类随机试验。 在384名女性中， AH或LCIS。我们将利用NCI社区肿瘤学研究计划的临床试验基础设施 （NCORP），包括少数民族/服务不足的网站。我们的主要有效性终点是化学预防 入组后6个月时的知情选择（目标1）。其次，我们将评估化学预防知识， 在基线、6个月和12个月时感知的乳腺癌风险/担忧和决策冲突，以及共享的 决策和化学预防吸收/坚持。对于试验的实施部分（Aim 2），我们将使用调查和关键信息提供者评估门户集成决策支持工具的影响 采访医疗保健提供者，包括专家和初级保健提供者，以及高风险妇女， AH或LCIS，以更好地了解化学预防吸收的障碍和促进因素。我们将使用RE-AIM （覆盖面、有效性、采用、实施、维持）框架。 该提案旨在克服不同妇女接受化学预防的重要障碍， AH或LCIS，高风险女性人群更有可能从SERM和AI中受益。提供EHR- 对患者和提供者的综合决策支持有可能改善知情的共同决策， 这是一项可持续的、可广泛传播的乳腺癌化学预防工作。

Breast cancer chemoprevention with selective estrogen receptor modulators (SERMs) and aromatase inhibitors (AIs) is underutilized, despite several randomized controlled trials demonstrating a 50-65% decrease in breast cancer incidence among high-risk women. Women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a 4- to 10-fold increased risk of breast cancer and derive up to a 70-80% relative risk reduction with SERMs or AIs. Reasons for low chemoprevention uptake include inadequate time for counseling, insufficient knowledge about SERMs and AIs, and concerns about side effects. We hypothesize that standard educational materials combined with decision support tools will increase chemoprevention informed choice compared to standard educational materials alone among women with AH or LCIS. We have developed web-based decision support tools, RealRisks for high-risk women and BNAV (Breast cancer risk NAVigation tool) for healthcare providers. Our patient-centered decision aid, RealRisks, is available in English and Spanish and has been rigorously tested in multi-ethnic high-risk women of varying health literacy, numeracy, and acculturation. After exposure to these tools, we have demonstrated an improvement in accurate breast cancer risk perceptions, chemoprevention knowledge and informed choice among multi-ethnic high-risk women. Our objective is to integrate these tools into clinic workflow via the electronic health record (EHR) and expand their use in a multicenter trial targeting women with AH or LCIS. To evaluate effectiveness (Aim 1) and implementation (Aim 2), we will conduct a hybrid cluster-randomized trial at 40 sites of standard educational materials combined with RealRisks and BNAV or standard educational materials alone among 384 women with AH or LCIS. We will leverage the clinical trials infrastructure of the NCI Community Oncology Research Program (NCORP), including minority/underserved sites. Our primary effectiveness endpoint is chemoprevention informed choice at 6 months after enrollment (Aim 1). Secondarily, we will assess chemoprevention knowledge, perceived breast cancer risk/worry, and decision conflict at baseline, 6 and 12 months, as well as shared decision-making and chemoprevention uptake/adherence. For the implementation component of the trial (Aim 2), we will evaluate the impact of portal integration of the decision support tools using surveys and key informant interviews of healthcare providers, including specialists and primary care providers, and high-risk women with AH or LCIS to better understand barriers and facilitators to chemoprevention uptake. We will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework for the implementation evaluation. This proposal seeks to overcome important barriers to chemoprevention uptake among diverse women with AH or LCIS, a population of high-risk women that is more likely to benefit from SERMs and AIs. Providing EHR- integrated decision support for patients and providers has the potential to improve informed shared decision- making about breast cancer chemoprevention, which is sustainable and may be widely disseminated.