Multicenter trial of decision support for breast cancer chemoprevention

选择性雌激素受体调节剂(SERM)和芳香酶联合应用预防乳腺癌 尽管几个随机对照试验显示抑制剂(Ais)的使用率下降了50%-65%，但它仍未得到充分利用。 在高危妇女中乳腺癌发病率的增加。女性不典型增生(AH)或小叶癌 原位(LCIS)患乳腺癌的风险增加4到10倍，相对风险降低高达70%-80% 使用SERM或AIS。化学预防接受率低的原因包括咨询时间不足、不足 关于SERM和AIS的知识，以及对副作用的担忧。我们假设标准的教育 与决策支持工具相结合的材料将增加化学预防的知情选择 标准教育材料仅在患有弱智或弱智的妇女中使用。 我们已经开发了基于Web的决策支持工具RealRisks for High Risks and BNAV(Breast 为医疗保健提供者提供癌症风险导航工具)。我们以患者为中心的决策辅助软件RealRisks现已面市 在英语和西班牙语中，已经在不同健康素养的多民族高危妇女中进行了严格的测试， 算术和文化适应。在接触了这些工具之后，我们展示了在精确度方面的改进 多民族高危人群乳腺癌风险认知、化学预防知识和知情选择 女人。我们的目标是通过电子健康记录(EHR)将这些工具集成到临床工作流程中，并 在一项针对患有AH或LCIS的妇女的多中心试验中扩大它们的使用。评估有效性(目标1)和 实施(目标2)，我们将在40个标准教育站点进行混合整群随机试验 与RealRisks和BNAV结合的材料或单独使用标准教育材料的384名患有 啊或者是LICIS。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)，包括少数族裔/服务不足的地点。我们的主要有效性终点是化学预防 在注册后6个月进行知情选择(目标1)。其次，我们将评估化学预防知识， 在基线、6个月和12个月以及共享时，感知的乳腺癌风险/担忧和决策冲突 决策和化学预防吸收/坚持。关于试验的执行部分(目标 2)，我们将使用调查和关键信息来评估门户集成决策支持工具的影响 采访了医疗保健提供者，包括专家和初级保健提供者，以及患有 AH或LCIS，以更好地了解化学预防吸收的障碍和促进者。我们将使用RE-AIM (REACH、有效性、采纳度、实施、维护)实施评估框架。 这项建议旨在克服在不同性别的妇女中接受化学预防的重要障碍 啊，或LC IS，这是一群更有可能从SERM和AIS中受益的高危女性。提供电子病历- 为患者和提供者提供的集成决策支持具有改善知情共享决策的潜力- 关于乳腺癌的化学预防，这是可持续的，可能会广泛传播。

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.