Developing a Patient Navigation Intervention to Improve Risk Management among Women at High Risk of Breast Cancer

项目摘要/摘要 有家族病史和/或乳腺癌(BC)遗传易感性的女性可能面临严重的 终生BC风险增加，但癌症风险管理选项(即监测常规、预防性 手术和药物)被证明可以降低风险并能够早期发现的只有一小部分人使用 她们被推荐的女性比例。迫切需要发展以证据为基础的 提高高危妇女护理标准的战略。基于人群的筛查计划，通常 通过筛查乳房X光检查服务，提供识别最高风险的重要承诺 女人。然而，有效降低BC发病率和死亡率还需要采取更多步骤来 交流个性化风险信息和风险管理选项；将女性与医疗保健联系起来 能够解释风险及其后果和风险管理选项的提供者；支持与风险相关的 决策；并促进风险管理决策和行为。先前的研究表明(A) 高危妇女采取风险管理行为的阶段性途径和(B)八个主要促进者 (与信息、支持、信仰、获得护理和解决实际障碍有关)，帮助推动 风险管理采用途径(R-MAP)的妇女。此外，基于调查的研究还包括 表明大多数高危妇女在接触这些促进者方面有很大差距， 这些差距在黑人女性中尤为严重。这项拟议研究的目标是设计、 开发和测试多维患者导航(PN)干预，以促进高危妇女的发展 通过阐述风险管理行为的八个主要促进者，介绍风险管理采用的途径。 目标1：确定特定信息、支持类型、降低障碍和推荐提供者 将推动BC高危女性沿着风险管理采用的道路，使用半 对高危黑人和白人女性的结构化采访。目标2：开发多维PN 以数据为指导，采取干预措施，推动高危妇女沿着风险管理收养途径前进 在AIM 1中产生，并由专家和患者代表组成的小组。目标3：测试以下项目的可行性 PN干预和招募参与者参加干预的随机对照试验。 75名参与者在筛查乳房X光检查后被确定为BC高危人群 按2：1的比例随机分为PN干预或仅提供信息的情况。基线调查和最终调查 八个月后将被用来评估主要假设，即大多数干预ARM参与者将 对PN干预感到满意，并检查其他几个基准的可行性。我们还将 描述性地估计沿R-MAP的进展和其他结果，以适当地支持随机 即将进行的对照试验(RCT)。这项研究将为这一创新的全面随机对照试验奠定基础 对种族和社会经济多样化人群的干预，并最终导致癌症 预防和控制高危妇女。

Project Summary/Abstract Women with a family history and/or genetic predisposition for breast cancer (BC) can face significantly elevated lifetime BC risk, but the cancer risk management options (i.e., surveillance routines, preventive surgeries, and medications) that are shown to reduce risk and enable early detection are used by only a small proportion of women for whom they are recommended. There is a critical need to develop evidence-based strategies to improve the standard of care for high-risk women. Population-based screening programs, usually facilitated through screening mammography services, offer significant promise of identifying most high-risk women. Effectively reducing BC morbidity and mortality, however, also requires additional steps to communicate personalized risk information and risk-management options; connect women with healthcare providers capable of explaining risk, its consequences, and risk-management options; support risk-related decision making; and facilitate risk-management decisions and behavior. Prior research has illuminated (a) a staged pathway along which high-risk women adopt risk-management behavior and (b) eight main facilitators (related to information, support, beliefs, access to care, and resolution of practical barriers) that help advance women along the risk-management adoption pathway (R-MAP). In addition, survey-based studies have demonstrated that the majority of high-risk women experience significant gaps in access to these facilitators, and that these gaps are particularly acute among Black women. The goal of the proposed study is to design, develop, and test a multi-dimensional patient navigation (PN) intervention to advance high-risk women along the risk-management adoption pathway by addressing the eight main facilitators of risk-management behavior. Aim 1: Determine the specific information, types of support, barrier reductions, and provider referrals that would advance women at high risk of BC along the pathway toward risk-management adoption, using semi- structured interviews with high-risk Black and White women. Aim 2: Develop a multi-dimensional PN intervention to advance high-risk women along the risk-management adoption pathway, guided by data generated in Aim 1 and a panel composed of experts and patient representatives. Aim 3: Test the feasibility of the PN intervention and of recruiting to a participants to a randomized controlled trial of the intervention. Seventy-five participants identified after a screening mammogram as potentially at high BC risk will be randomized to PN-intervention or information-only conditions in a 2:1 ratio. Baseline surveys and final surveys after eight months will be used to assess the primary hypothesis that most intervention-arm participants will be satisfied with the PN intervention, and to check several other benchmarks of feasibility. We will also descriptively estimate progress along the R-MAP and other outcomes, to appropriately power a randomized controlled trial (RCT) to come. This research will set the stage for a full-scale RCT of this innovative intervention with racially and socioeconomically diverse populations, and ultimately contribute to cancer prevention and control among high-risk women.