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: 10593908
• 负责人: LAURA J ESSERMAN
• 金额: $ 181.76万
• 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/10593908
• 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; Ethnic Origin; Exhibits; Family; Feedback; Florida; Frequencies; Funding; Genes; Genetic Predisposition to Disease; Geography; Goals; Guidelines; Health; Healthcare; Home; 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; 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; breast density; cancer predisposition; clinical research site; comorbidity; cost; demographics; design; experience; 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; preventive intervention; programs; psychologic; recruit; routine screening; screening; screening guidelines; socioeconomics; study population; testing services; trial comparing; trial design; trial enrollment; 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

项目总结/摘要 WISDOM研究（根据风险衡量标准进行筛查的女性）是一项 一项比较个性化乳腺癌筛查方法的实用性试验， 筛查的强度和方式取决于分层的个人风险--相对于黄金 年度筛查标准。目标是确定个性化方法是否符合 安全、不那么病态、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（在心理、身体和心理上以更低的成本获得更好的结果）， 财政上）。 在这份“扩大WISDOM研究的多样性、范围和普遍性”的提案中，我们 寻求支持，将研究扩大到全国其他地点， 招募，提高学习能力，增加地理和人口多样性， 研究参与者。这样做的目的是为了增加研究的普遍性 结果使用独特的覆盖范围与证据进展模型，我们已获得保险 来自多个付款人的覆盖范围和推广合作，使我们有机会注册 来自多个地区和不同种族的约600万妇女的额外人口， 社会经济背景。这个建议将使我们能够增加的网站网络将 允许我们创建一个协作组，以不断改进筛选，并了解谁是在 哪种癌症的风险。 个性化筛查包括基于家族史、暴露、 乳腺密度、合并症和遗传易感性（9个基因中存在突变 与筛选和遗传基因中的小变异相结合， 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， 使我们能够将这些重要的发现转化为实践。我们使用的是一种自适应的 在试验过程中将风险模型作为新信息进行更新的方法 出现了个性化的方法产生一个综合风险评分，使我们能够分配一个 开始的年龄、停止的年龄、筛查的频率和筛查的方式。 R 01的具体目标是： 1.开设新的临床研究中心，具有招募目标人群的经验，并在文化上使用 有针对性的材料，以增加WISDOM研究的数量和多样性 人口 2.通过国家合作伙伴关系、集中活动加强试验入组和保留 并通过真实的时间反馈进行嵌入式分析