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

项目摘要 基于家族史的简短和低成本筛查评估，以确定BRCA高风险家族- 相关的癌症已经得到国家指南的认可（例如，USPSTF）和公共卫生组织 (e.g., CDC）。公共卫生部门为系统地接触历史上遗留下来的妇女提供了基础设施 癌症基因组的进展（例如，无保险，黑人妇女，农村居民）。格鲁吉亚是少数几个 在全州范围内对BRCA相关癌症进行家族史筛查。尽管有潜力， 目前以诊所为基础的查明高危妇女的办法是不可持续的，而且范围有限。 此外，后续癌症筛查的采用是次优的，并且仅关注筛查为高风险的女性。 遗传风险因此，我们提出了一个两阶段的研究，以适应格鲁吉亚现有的全州家族史 筛查计划，并评估其有效性，以增加接受筛查的妇女的数量和多样性。 家族史评估和获得风险分层随访服务的机会。为指导 探索，准备，实施和维持（EPIS）框架，这两个阶段的研究的目的 第一阶段（探索和准备阶段），目标1：对GA CORE现有的 BRCA相关癌症的全州家族史筛查计划，以最大限度地提高可持续计划的覆盖面 提高沟通的适宜性和有效性。第二阶段（实施阶段），目标2：使用多个 一项研究中心、平行组、整群随机对照试验，以评估调整后的方案相对于 目前的筛查计划，以促进家庭史筛查的吸收和正确的筛查结果， 25岁及以上的妇女在14个公共卫生诊所中的6个接受治疗， 格鲁吉亚西南部。次要结局包括接受适当的风险分层筛查（例如，高 风险：遗传咨询和检测;低风险：适当的乳腺成像筛查）。目标3：使用RE-AIM （覆盖范围、有效性、采用、实施和维护）框架，以进行实施 研究评估以衡量项目过程指标（例如，覆盖面、忠诚度、障碍/促进者）， 影响方案执行和可持续性。我们的应用程序将是第一个评估 采用可持续的多层次、以人群为基础的方法，实施循证癌症遗传筛查， 提高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.