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

评估基于证据的家族史筛查计划，以扩大农村公共卫生诊所 BRCA 相关癌症筛查的覆盖范围和采用率

• 批准号: 10731993
• 负责人: Yue Guan
• 金额: $ 61.57万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-06 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10731993
• 关键词: Address; Adopted; Age; Awareness; BRCA mutations; Black race; Breast Cancer Risk Factor; Caring; Clinic; Clinic Visits; Communication; Consultations; Disparity; Education; Effectiveness; Eligibility Determination; Ethnic Population; Evaluation Research; Exploration, Preparation, Implementation, and Sustainment; Family; Family history of; Genetic; Genetic Risk; Genetic Screening; Genetic Services; Genomics; Goals; Guidelines; Health Services Research; Infrastructure; Left; Life; Malignant Neoplasms; Measures; Minority Groups; Oncology; Phase; Population; Population Heterogeneity; Poverty; Preparation; Prevention; Process; Program Sustainability; Public Health; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recording of previous events; Research; Risk; Rural; Rural Community; Screening Result; Screening for cancer; Services; Site; Testing; Time; Uninsured; United States Preventative Services Task Force; Visit; Woman; aggressive breast cancer; black women; breast imaging; cancer genetics; cancer genomics; cancer prevention; cost; effectiveness evaluation; ethnic minority population; evidence base; federal poverty level; follow-up; genetic testing; health disparity; health organization; high risk; implementation framework; implementation research; improved; insight; mutation carrier; population based; program dissemination; programs; psychosocial; racial diversity; racial population; risk stratification; rural area; rural dwellers; screening; screening program; secondary outcome; service uptake; success; underserved community; uptake

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.

项目概要 简短且低成本的基于家族史的筛查评估，以识别 BRCA 高风险家庭 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，疾病预防控制中心）公共卫生部门提供了一个基础设施，以某种方式帮助历史上离开的妇女。 由于癌症基因组的进步（例如，没有保险、黑人妇女、农村居民），佐治亚州是少数几个州之一。 尽管有潜力，但已实施针对 BRCA 相关癌症的联邦家族史筛查。 目前基于临床的识别高危女性的方法不可持续，而且影响范围有限。 此外，后续癌症筛查的采用率并不理想，并且仅关注筛查结果较高的女性。 因此，我们建议进行一项两阶段研究，以适应乔治亚州现有的被告家族史。 筛查计划并评估其有效性，以增加接受治疗的妇女的数量和多样性 家族史评估和获得风险分层后续服务的机会。 探索、准备、实施和维持（EPIS）框架，这个两阶段研究的目的 是：第一阶段（探索和准备阶段），目标 1：对 GA CORE 现有的进行多层次的调整 针对 BRCA 相关癌症的避难所家族史筛查计划，以最大限度地扩大可持续计划的影响范围 提高沟通的适用性和有效性 第二阶段（实施阶段），目标 2：使用多种方式。 现场、平行组、整群随机对照试验，以评估适应计划相对的有效性 现行筛查计划，以促进家族史筛查的普及和正确的筛查结果 对在 14 家公共卫生诊所中最多 6 家接受护理的 25 岁及以上女性进行解释 乔治亚州西南部。次要结果包括采取适当的风险分层筛查（例如，高风险分层筛查）。 风险：遗传咨询和检测；低风险：适当的乳腺影像筛查）。 （范围、有效性、采用、实施和维护）框架来进行实施 研究评估，以衡量项目过程指标（例如，覆盖范围、保真度、障碍/促进因素） 影响实施计划和可持续性。我们的应用程序将是首先评估的应用程序之一。 可持续的多层次基于人群的方法来实施循证癌症遗传筛查和 增加基因组进展在农村地区不同人群中公平分配的可能性。