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.

项目摘要 简短和低成本的基于家庭历史的筛查评估，以确定BRCA高风险的家庭 相关的癌症已得到国家准则（例如USPSTF）和公共卫生组织的认可 （例如，CDC）。公共卫生部门提供了一个基础设施，用于系统地接触历史上的妇女 出于癌症基因组进展（例如，没有保险，黑人妇女，粗糙的居民）。佐治亚州是少数州之一 为了实施与BRCA相关癌症的全州家族史筛查。尽管有潜力 当前基于诊所的识别处于危险中的诊所的方法是不可持续的，并且覆盖范围有限。 此外，对随访癌症筛查的吸收是次优的，仅关注筛查的女性 遗传风险。因此，我们提出了一项两阶段的研究，以适应佐治亚州现有的全州家族史 筛选计划并评估其有效性，以增加接受的妇女的数量和多样性 家族史评估和获取风险分层的后续服务的机会。由 探索，准备，实施和维持（EPIS）框架，这项两阶段研究的目的 是：第一阶段（探索与准备阶段），目标1：对GA Core的现有的多级改编 与BRCA相关癌症的全州家庭历史筛查计划，以最大化可持续性计划 并提高沟通的适用性和有效性。第二阶段（实施阶段），目标2：使用多个 站点，平行组，群集随机对照试验，以评估适应计划的相关性的有效性 在促进家族史筛查和正确筛选结果的当前筛选计划中 25岁及以上妇女的解释在14个公共卫生诊所中最多可接受护理 佐治亚州西南部。次要结果包括摄取适当的风险分层筛查（例如，高 风险：遗传咨询和测试；低风险：适当的乳房成像筛查）。目标3：使用re-aim （达到，有效性，采用，实施和维护）进行实施的框架 研究评估以衡量计划过程指标（例如，覆盖范围，忠诚度，障碍/促进者） 影响计划实施和可持续性。我们的申请将是最早评估 可持续的多层次人群基于循证癌症基因筛查和 为了增加在粗糙地区的潜水员种群中基因组进步的公平分布的可能性。