Increasing breast cancer chemoprevention in the primary care setting

描述（由申请人提供）：乳腺癌是美国女性中最常见的恶性肿瘤，该疾病的一级预防是一个主要的公共卫生问题。尽管几项随机对照试验表明高危妇女的乳腺癌发病率降低了50-65%，但使用抗雌激素药物（如他莫昔芬、雷洛昔芬和依西美坦）进行乳腺癌化学预防的效果尚未得到充分利用。许多妇女可能不知道她们的高危状态，因为我们无法在初级保健环境中对她们进行充分的筛查。其他低使用率的原因包括咨询时间不足，对降低风险策略的了解不足，以及对副作用的担忧。与非西班牙裔白人相比，来自少数种族/族裔的妇女不太可能寻求预防措施，导致这些人群的临床结果较差。我们假设，将以患者为中心的决策辅助与以医生为中心的决策支持工具整合到临床工作流程中，将提高乳腺癌风险感知的准确性，促进专业风险咨询的转诊，并增加化学预防的吸收。在我们的乳腺诊所，高危女性的化学预防吸收率为37%，而其他高危人群的吸收率不到5%。我们的目标是通过向更多在初级保健环境中接受筛查的不同种族/民族的妇女提供专门的风险咨询，扩大我们在乳腺诊所的成功。我们将使用一种新的乳腺癌风险导航（BNAV）工具，该工具将Gail乳腺癌风险模型纳入电子健康记录。为了解决与患者相关的化学预防障碍，我们的研究小组开发了一个决策辅助的初始原型，RealRisks，它允许参与者通过活动体验风险。我们提出以下目标：1a)应用以用户为中心的设计来评估和完善乳腺癌化学预防的RealRisks；1b)评估RealRisks对乳腺癌诊所和高风险登记中心确定的50名高风险妇女乳腺癌风险认知准确性的影响；2a)为初级保健提供者设计和评估BNAV，以促进识别有资格进行化学预防的高危妇女；2b)比较在初级保健诊所筛查的50名高危妇女的转诊率，随机分配到BNAV组和无BNAV组；3)对400名在初级保健机构确定的高危妇女进行随机对照试验，采用2 × 2析因设计，将RealRisks和BNAV单独或联合与常规护理进行比较。主要终点是6个月时的化学预防。其次，我们将评估风险感知的准确性，乳房诊所的转诊率，以及各种患者和医生报告的结果。这一建议旨在克服在初级保健环境中使用化学预防的重要障碍。鉴于抗雌激素对高危人群一级预防的有效性已得到证实，提高乳腺癌化学预防的使用可能会显著减轻这种疾病的公共卫生负担。

DESCRIPTION (provided by applicant): Breast cancer is the most common malignancy among women in the U.S. and the primary prevention of this disease is a major public health issue. Breast cancer chemoprevention with antiestrogens, such as tamoxifen, raloxifene, and exemestane, is underutilized, despite several randomized controlled trials demonstrating a 50-65% decrease in breast cancer incidence among high-risk women. Many women may be unaware of their high-risk status due to our inability to adequately screen them in the primary care setting. Other reasons for low uptake include inadequate time for counseling, insufficient knowledge about risk- reducing strategies, and concerns about side effects. Women from racial/ethnic minorities are less likely to seek preventive measures, contributing to poorer clinicl outcomes in these populations compared to non- Hispanic whites. We hypothesize that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake. In our breast clinic, the chemoprevention uptake rate among high-risk women is 37%, compared to less than 5% reported for other high-risk populations. Our goal is to expand our success in the breast clinic by offering specialized risk counseling to a broader population of racially/ethnically divere women screened in the primary care setting. We will use a novel breast cancer risk navigation (BNAV) tool, which incorporates the Gail breast cancer risk model into the electronic health record. To address patient-related barriers to chemoprevention, our research group developed an initial prototype of a decision aid, RealRisks, that allows participants to experience risk through an activity. We propose to conduct the following aims: 1a) To apply a user-centered design to evaluate and refine RealRisks for breast cancer chemoprevention; 1b) To evaluate the effects of RealRisks on accuracy of breast cancer risk perception among 50 high-risk women identified at our breast clinic and high-risk registries; 2a) To design and evaluate BNAV for primary care providers to facilitate the identification of high-risk women eligible for chemoprevention; 2b) To compare referral rates to the breast clinic among 50 high-risk women screened in primary care clinics randomized to BNAV vs. no BNAV; 3) To conduct a randomized controlled trial with a 2x2 factorial design of RealRisks and BNAV, either alone or in combination, compared to usual care in 400 high-risk women identified in the primary care setting. The primary endpoint is chemoprevention uptake at 6 months. Secondarily, we will assess accuracy of risk perception, referral rates to the breast clinic, and various patient- and physician-reported outcomes. This proposal seeks to overcome important barriers to chemoprevention uptake in the primary care setting. Given the proven efficacy of antiestrogens for primary prevention in high-risk populations, higher uptake of breast cancer chemoprevention may significantly reduce the public health burden of this disease.