Applying Breast Density to Risk Counseling

 描述(由申请人提供)：去年超过232,000名患浸润性乳腺癌的妇女中的许多人没有意识到疾病风险因素、她们的个人风险和可用的风险管理策略。除了家族史等众所周知的风险因素外，乳房致密(“密度”)是乳腺癌风险最大的因素之一。美国近一半的州现在要求在常规筛查乳房X光检查后披露密度状况。披露提供了一个机会，以捕捉由于密度和其他风险因素(如家族病史)而处于临床高风险状态的妇女，并告知她们可以选择的风险管理方案。长期以来，指南一直建议对临床上乳腺癌风险升高的女性进行风险咨询，包括讨论化学预防和额外的乳房成像，如MRI。虽然吸收是一个基于个人偏好的决定，但人们对这些风险管理选择的使用率很低，提高吸收的努力也是有限的。我们的试点数据表明，患者对以密度为重点的风险咨询有着浓厚的兴趣，我们的试点干预可以改变风险管理意图。这些数据，再加上强制性密度报告、扩大的风险管理指南和ACA下的服务覆盖范围，为扩大乳腺癌风险管理和评估经济影响提供了前所未有的机会。我们提出了第一个随机对照试验来评估一种密度披露方法。我们的目标是鼓励在不增加痛苦的情况下采用指导方针知情的风险管理。在保护动机理论的指导下，我们将在群体健康(40-69岁)成员中实施和评估基于网络的互动干预与常规护理，这些成员的高乳房密度和其他风险因素使他们处于乳腺癌的高5年(1.66%)或终身(20%)风险。我们将评估干预效果的机制，并在试验的同时进行经济评估。患者将在随机化前基线以及随机化后6周和12个月完成评估。我们将把这些自我报告数据与医疗保健利用和成本数据结合起来，以评估我们干预措施对公共健康的潜在影响。我们的目标是1)评估干预对摄取和痛苦的影响，2)确定干预对摄取的影响的中介/调节因素，以及3)延长试验的时间范围，以使用癌症干预和监测建模网络(CISNET)模型从不同的角度估计干预的终生成本、收益和危害。我们的试验将通过告知全面的国家政策整合、要求密度披露和估计我们方法的成本效益来推动该领域的发展。

 DESCRIPTION (provided by applicant): Many of the over 232,000 women who developed invasive breast cancer last year were unaware of disease risk factors, their personal risk, and available risk management strategies. Along with better-known risk factors such as family history, having dense breasts ("density") is one of the strongest breast cancer risk factors. Almost half of US states now require disclosure of density status following routine screening mammography. Disclosure provides an opportunity to capture women who are at clinically elevated risk due to density and additional risk factors, such as family history, and to inform them of risk management options available to them. Guidelines have long recommended risk counseling for women with clinically elevated breast cancer risk, including discussion of chemoprevention and additional breast imaging such as MRI. While uptake is an individual, preference-based decision, population use of these risk management options is low and efforts to improve uptake are limited. Our pilot data suggest that patients have strong interest in density-focused risk counseling and that our pilot intervention can shift risk management intentions. These data, together with the confluence of mandatory density reporting, expanded risk management guidelines, and coverage of services under the ACA provides an unprecedented opportunity to expand breast cancer risk management and to assess the economic impact. We propose the first randomized controlled trial to evaluate a method of density disclosure. Our goal is to encourage uptake of guideline-informed risk management without increasing distress. Guided by Protection Motivation Theory, we will implement and evaluate a web-based interactive intervention vs. usual care among members of Group Health (aged 40-69) whose high breast density and other risk factors place them at high 5-year (>1.66 percent) or lifetime (>20 percent) risk for breast cancer. We will assess the mechanisms of intervention effect and conduct an economic evaluation alongside the trial. Patients will complete assessments at pre-randomization baseline, as well as 6 weeks and 12 months post-randomization. We will integrate these self-report data with healthcare utilization and cost data to assess the potential public health impact of our intervention. Our aims are to 1) assess intervention effects on uptake and distress, 2) identify mediators/moderators of intervention impact on uptake, and 3) extend the time horizon of the trial to estimate the lifetime costs, benefits, and harms of the intervention from different perspectives using a Cancer Intervention and Surveillance Modeling Network (CISNET) model. Our trial will move the field forward by informing the sweeping national policy integration requiring density disclosure and estimating the cost-effectiveness of our approach.