Diversifying Acute Leukemia Clinical Trial Enrollment Through Multilevel Intervention

项目摘要/摘要 癌症临床试验登记中的种族-民族差异对研究结果的偏见，限制了推广，以及 减少公平获得试验提供的新疗法和高质量护理的机会。急性髓系白血病和 淋巴细胞性白血病是侵袭性但可治愈的血癌，影响全国17万人，以及 黑人和西班牙裔成年癌症患者的发病率调整后的试验登记人数是最低的 已知--比白人患者少85%。这些白血病有一种独特的护理模式，限制了其效用 现有的、以社区为基础的登记多样化干预措施：患者需要快速住院治疗和以上治疗 到一半的人在第四级转诊中心看到，那里发生了相当大比例的不同注册。 试验设计的可修改元素、低提供者授权和患者犹豫不决的行为似乎发挥了作用 在延续这一差距方面发挥了关键作用。最近的政策和数据科学创新现在允许癌症登记 以及电子健康档案数据整合，用于招生多样性监测和干预发展。 该提案的目标是利用这些进展，开发三个相辅相成的项目 共同构成一个多层次的干预措施，以克服急性白血病多样化登记的障碍。在……里面 目的1、开发一个抢先试验方案审查系统，以识别急性白血病试验设计 使用预测性风险评分和社区评估与入学差距相关的要素。在……里面 目标2，构建急性白血病提供者招生多样性绩效反馈界面 在医疗记录里，并且是飞行员。在目标3中，注册对等支持移动应用程序将被 为急性白血病患者开发和试行。这些项目的完成将带来一个全面的 开发了多水平干预措施，有可能可持续地使急性白血病试验登记多样化 在规模上，这将通过一个大型的随机试验进行测试。这项工作将同时产生 监测招生多样性和差异干预评估的可复制方法 机构和癌症类型。这项研究将得到培训的补充，培训将培养以下方面的专业知识 行为干预发展、基于社区的参与性研究与多层次健康差距 通过正式的课程作业、研讨会、研讨会和强大的导师和 合作者。这项工作将在一家领先的癌症中心进行，该中心有提供护理的记录 创新和早期职业研究人员的成功。总之，这项研究建议和培训计划针对的是 主要研究人员的近期目标是成为一名具有血癌特征的独立研究人员 提供护理服务的不公平现象和制定干预措施，以改善卫生服务的可及性、质量和成果 被边缘化的群体。通过创造多层次的干预，有可能提高安全性，有效性， 针对不同参与者的临床研究的质量、可推广性和社区参与度，本提案 也符合首席调查员的长期职业目标，即确保血癌护理提供的公平性。

PROJECT SUMMARY/ABSTRACT Race-ethnic disparities in cancer clinical trial enrollment bias research findings, limit generalizability, and reduce equitable access to the novel therapies and high-quality care that trials provide. Acute myeloid and lymphoblastic leukemia are aggressive but curable blood cancers that affect 170,000 persons nationally, and incidence-adjusted trial enrollment of Black and Hispanic adults with these cancers is among the lowest known—up to 85% less than White patients. These leukemias have a distinct care pattern that limits the utility of existing, community-based enrollment diversity interventions: patients require rapid inpatient therapy and up to half are seen at quaternary referral centers, where a significant proportion of disparate enrollment occurs. Modifiable elements of trial design, low provider empowerment, and patient hesitancy behaviors appear to play key roles in perpetuating this disparity. Recent policy and data science innovations now allow cancer registry and electronic health record data integration for enrollment diversity monitoring and intervention development. The goal of this proposal is to leverage these advances, developing three complementary projects that together comprise a multilevel intervention for overcoming barriers to diverse enrollment in acute leukemia. In Aim 1, a preemptive trial protocol review system will be developed to identify acute leukemia trial design elements associated with enrollment disparities using a predictive risk score and community assessment. In Aim 2, an enrollment diversity performance feedback interface for acute leukemia providers will be constructed within the medical record and piloted. In Aim 3, an enrollment peer support mobile application will be developed and piloted for patients with acute leukemia. Completion of these projects will result in a fully developed multilevel intervention that has the potential to sustainably diversify acute leukemia trial enrollment at scale, which will be tested through a large, randomized trial. This work will simultaneously generate replicable methods for monitoring enrollment diversity and disparities intervention assessment across institutions and cancer types. This research will be complemented by training that will cultivate expertise in behavioral intervention development, community-based participatory research, and multilevel health disparity interventions through formal coursework, workshops, seminars, and a strong team of mentors and collaborators. The work will take place within a leading cancer center that has a track record of care delivery innovation and early-career investigator success. Together, this research proposal and training plan target the primary investigator’s near-term objective of becoming an independent investigator characterizing blood cancer care delivery inequities and developing interventions to improve access, quality, and outcomes for marginalized groups. By creating a multilevel intervention that has the potential to improve the safety, efficacy, quality, generalizability, and community engagement of clinical research for diverse participants, this proposal also aligns with primary investigator’s long-term career goal of ensuring equity in blood cancer care delivery.