Extending the Diversity, Reach, and Generalizability of the WISDOM Study

扩展 WISDOM 研究的多样性、范围和普遍性

• 批准号: 9888251
• 负责人: LAURA J ESSERMAN
• 金额: $ 150.84万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9888251
• 关键词: Adopted; Adoption; Advocate; Age; Alabama; Blue Cross; Blue Shield; Boston; Breast; Breast Cancer Detection; Breast Cancer Risk Factor; Breast Cancer Treatment; California; Cancer Biology; Caring; Chicago; Clinical; Clinical Services; Collaborations; Conflict (Psychology); Confusion; Contracts; Country; Data; Disease; Employee; Enrollment; Ensure; Ethnic Origin; Exhibits; Family; Feedback; Florida; Frequencies; Funding; Genes; Genetic Predisposition to Disease; Geography; Goals; Gold; Guidelines; Health; Healthcare; Home environment; Illinois; Individual; Infrastructure; Inherited; Insurance Carriers; Insurance Coverage; Intention; International; Internist; Investments; Knowledge; Learning; Louisiana; Malignant Neoplasms; Mammography; Measures; Midwestern United States; Minnesota; Modality; Modeling; Modernization; Mutation; New Jersey; Oregon; Outcome; Paralysed; Participant; Patient-Focused Outcomes; Population; Population Heterogeneity; Predisposition; Preventive Intervention; Randomized; Recommendation; Recording of previous events; Research Institute; Risk; Risk Assessment; Risk Factors; Safety; Science; Secure; Single Nucleotide Polymorphism; Site; Societies; South Carolina; Target Populations; Technology; Testing; Time; Traction; Translating; United States; United States Department of Veterans Affairs; Universities; Update; Utah; Variant; Veterans; Washington; Woman; arm; base; breast density; clinical research site; comorbidity; cost; demographics; design; experience; geographic population; high risk; improved; individualized medicine; innovation; knowledge translation; learning progression; malignant breast neoplasm; outreach; patient oriented; personalized approach; personalized screening; polygenic risk score; population based; pragmatic trial; precision medicine; preference; programs; psychologic; recruit; routine screening; screening; screening guidelines; socioeconomics; study population; testing services; trial comparing; trial design; uptake

PROJECT SUMMARY/ABSTRACT The WISDOM Study (Women Informed to Screen Depending on Measures of risk) is a pragmatic trial comparing a personalized approach to breast cancer screening – in which the intensity and modality of screening is dependent upon stratified personal risk -- against the gold standard of annual screening. The goal is to determine whether a personalized approach is as safe, less morbid, better accepted by women, encourages uptake of preventive interventions, and is of higher health care value (better outcomes at less cost psychologically, physically, and financially). In this proposal `Expanding the WISDOM Study's Diversity, Reach, and Generalizability', we are seeking support to expand the study to additional sites around the country to enhance recruitment, improve study power and increase both the geographic and population diversity of study participants. By doing so, our intention is to increase the generalizability of the study results. Using a unique coverage with evidence progression model, we have secured insurance coverage and outreach collaboration from multiple payers, giving us the opportunity to enroll from an additional population of ~6 million women across multiple regions and varied ethnic and socioeconomic backgrounds. The network of sites that this proposal will enable us to add will allow us to create a collaborative group to continuously improve screening and learn who is at risk for what kind of cancer. The personalized screening arm includes a risk assessment based on family history, exposures, breast density, co-morbidity and genetic predisposition (presence of mutations in the 9 genes associated with screening and the combination of the small variation in inherited genes, the single nucleotide polymorphisms, into a polygenic risk score or PRS). Importantly, the PRS score is tailored to different ethnicities based on advances in the science of risk assessment, allowing us to translate these important findings into practice. We are using an adaptive approach in which the risk model is updated over the course of the trial as new information emerges. The personalized approach yields an integrated risk score that allows us to assign an age to start, an age to stop, a frequency of screening, and a modality for screening. The R01 Specific Aims are to: 1. Open new clinical sites with experience enrolling targeted populations and use culturally targeted materials to increase the numbers in and diversity of the WISDOM study population 2. Enhance trial enrollment and retention through national partnerships, centralized campaigns across the network and embedded analytics with real time feedback

项目概要/摘要 WISDOM 研究（根据风险衡量标准告知女性进行筛查）是一项 比较个性化乳腺癌筛查方法的务实试验——其中 筛查的强度和方式取决于分层的个人风险——针对黄金 年度筛查标准。目标是确定个性化方法是否与 安全，较少发病，更容易被妇女接受，鼓励采取预防性干预措施， 并且具有更高的医疗保健价值（以更低的心理、身体和心理成本获得更好的结果） 财务上）。 在这项“扩大 WISDOM 研究的多样性、范围和普遍性”提案中，我们 寻求支持以将研究扩展到全国其他地点，以加强 招募、提高研究能力并增加地理和人口多样性 研究参与者。通过这样做，我们的目的是提高研究的普遍性 结果。使用具有证据进展模型的独特承保范围，我们获得了保险 来自多个付款人的覆盖和外展合作，使我们有机会注册 来自多个地区、不同种族和群体的约 600 万女性人口 社会经济背景。该提案将使我们能够添加的站点网络将 让我们创建一个协作小组来不断改进筛选并了解谁在 患哪种癌症的风险。 个性化筛查包括基于家族史、暴露情况的风险评估， 乳腺密度、共病和遗传倾向（9 个基因中是否存在突变） 与筛选和遗传基因微小变异的组合有关， 单核苷酸多态性转化为多基因风险评分或 PRS）。重要的是，PRS 根据风险评估科学的进步，为不同种族量身定制分数， 使我们能够将这些重要发现转化为实践。我们正在使用自适应 风险模型在试验过程中更新为新信息的方法 出现。个性化方法产生综合风险评分，使我们能够分配 开始年龄、停止年龄、筛查频率和筛查方式。 R01 的具体目标是： 1. 开设新的临床中心，具有招募目标人群和文化使用的经验 有针对性的材料，以增加 WISDOM 研究的数量和多样性 人口 2. 通过国家伙伴关系、集中宣传活动提高试验注册率和保留率 跨网络和嵌入式分析并提供实时反馈