Evaluating an evidence-based family history screening program adapted to increase reach and uptake of screening for BRCA-associated cancers in rural public health clinics

项目总结 基于家族史的简短和低成本筛查评估，以确定BRCA的高危家庭- 相关癌症已得到国家指南(例如，USPSTF)和公共卫生组织的认可 (例如，CDC)。公共卫生部门为有系统地接触历史上被遗弃的女性提供基础设施 由于癌症基因组的进步(例如，未参保的黑人妇女、农村居民)。格鲁吉亚是为数不多的几个州之一。 实施了全州范围的BRCA相关癌症的家族史筛查。尽管它有潜力， 目前以诊所为基础的识别高危妇女的方法是不可持续的，而且覆盖范围有限。 此外，接受后续癌症筛查的情况并不理想，而且只关注筛查结果较高的女性。 遗传风险。因此，我们建议进行两个阶段的研究，以适应佐治亚州现有的全州家族史 筛查计划并评估其有效性，以增加接受治疗的妇女人数和多样性 家庭病史评估和获得风险分层后续服务的机会。在指导下 探索、准备、实施和维持(EPIS)框架，本研究分两个阶段进行 是：第一阶段(探索和准备阶段)，目标1：对GA核心现有的 全州范围的BRCA相关癌症家族史筛查计划，以最大限度地扩大可持续计划的覆盖面 提高沟通适宜性和有效性。第二阶段(实施阶段)，目标2：使用多种 现场、平行组、整群随机对照试验评价改编方案的效果 以现行筛查方案促进对家族史筛查和正确筛查结果的接受 在中国14家公共卫生诊所中最多6家接受护理的25岁及以上女性中的解释 佐治亚州西南部。次要结果包括采用适当的风险分层筛查(例如 风险：遗传咨询和检测；低风险：适当的乳房成像筛查)。目标3：使用RE-AIM (覆盖范围、有效性、采用、实施和维护)实施框架 研究评估，以衡量计划流程指标(例如，覆盖范围、忠诚度、障碍/促进者)，这些指标可能 影响计划的实施和可持续性。我们的应用程序将是第一批评估 可持续的基于多层次人群的方法来实施基于证据的癌症基因筛查和 增加基因组进步在农村地区不同人群中公平分配的可能性。

PROJECT SUMMARY Brief and low-cost family history-based screening assessments to identify families at high risk for BRCA- associated cancers have been endorsed by national guidelines (e.g., USPSTF) and public health organizations (e.g., CDC). Public health departments offer an infrastructure for systematically reaching women historically left out of cancer genomic advances (e.g., uninsured, Black women, rural residents). Georgia is among the few states to have implemented statewide family history screening for BRCA-associated cancers. Despite its potential, current clinic-based approaches that identify at risk women are not sustainable and show limited reach. Additionally, uptake of follow-up cancer screening is suboptimal and solely focuses on women screened as high genetic risk. Therefore, we propose a two-phase study to adapt Georgia’s existing statewide family history screening program and evaluate its effectiveness to increase the number and diversity of women who receive family history assessment and the opportunity to access risk-stratified follow-up services. Guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) framework, the aims of this two-phase study are: Phase I (Exploration & Preparation stages), Aim 1: Conduct a multilevel adaptation of GA CORE’s existing statewide family history screening program for BRCA-associated cancers to maximize sustainable program reach and improve communication suitability and effectiveness. Phase II (Implementation stage), Aim 2: Use a multi- site, parallel group, cluster randomized controlled trial to evaluate effectiveness of the adapted program relative to the current screening program in promoting uptake of family history screening and correct screening result interpretation among women ages 25 and older who are receiving care in up to 6 of 14 Public Health Clinics in Southwest Georgia. Secondary outcomes include the uptake of appropriate risk-stratified screening (e.g., high risk: genetic consultation and testing; low risk: appropriate breast imaging screening). Aim 3: Use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to conduct an implementation research evaluation to measure program process indicators (e.g., reach, fidelity, barriers/facilitators) that may influence program implementation and sustainability. Our application will be among the first to evaluate a sustainable multi-level population-based approach to implement evidence-based cancer genetic screening and to increase the likelihood for fair distribution of genomic advances among diverse populations in rural areas.