Diversifying Acute Leukemia Clinical Trial Enrollment Through Multilevel Intervention

通过多层次干预使急性白血病临床试验招募多样化

• 批准号: 10505579
• 负责人: Andrew Hantel
• 金额: $ 25.58万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10505579
• 关键词: Acute Myelocytic Leukemia; Acute leukemia; Address; Adult; Affect; Attitude; Behavior; Behavior Therapy; Black race; Cancer Center; Cancer Control; Caring; Catchment Area; Clinical Research; Communities; Complement; Complex; Comprehensive Cancer Center; Data; Data Science; Educational workshop; Electronic Health Record; Elements; Enrollment; Ensure; Feedback; Focus Groups; Goals; Hematopoietic Neoplasms; Hispanic; Improve Access; Incidence; Incubators; Inpatients; Institution; Intervention; Intervention Trial; Knowledge; Link; Lymphoblastic Leukemia; Malignant Neoplasms; Medical Records; Mentors; Methods; Modeling; Monitor; National Cancer Institute; Outcome; Outpatients; Participant; Patients; Patterns of Care; Performance; Persons; Physicians; Pilot Projects; Play; Policies; Population; Preparation; Protocols documentation; Provider; Qualitative Methods; Quality of Care; Race; Registries; Reporting; Research; Research Personnel; Research Proposals; Research Training; Risk; Safety; Scientist; Services; Social Work; Structure; System; Testing; Time; Training; Work; arm; base; bilingualism; biomedical referral center; cancer care; cancer clinical trial; cancer health disparity; cancer type; care delivery; career; clinical trial enrollment; community based participatory research; community engagement; cost; data integration; demographics; empowerment; ethnic disparity; ethnic diversity; health disparity; implementation science; improved; innovation; leukemia; marginalized population; mobile application; model design; neoplasm registry; novel; novel therapeutics; patient-level barriers; peer; peer support; primary outcome; provider-level barriers; randomized trial; secondary outcome; stem; success; therapy design; therapy development; tool; trial design; usability

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.

项目总结/摘要 癌症临床试验入组中的种族-民族差异导致研究结果偏倚，限制了普遍性， 减少公平获得试验提供的新疗法和高质量护理的机会。急性髓系和 淋巴母细胞白血病是侵袭性但可治愈的血液癌症，影响全国17万人， 黑人和西班牙裔成年人患这些癌症的发病率调整试验入组率是最低的 已知-比白色患者低85%。这些白血病有一个独特的护理模式，限制了效用 现有的，以社区为基础的招募多样性干预措施：患者需要快速住院治疗， 到一半的人在四级转诊中心就诊，在那里有很大比例的不同登记。 试验设计的可修改元素、低提供者授权和患者犹豫行为似乎起作用 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 和电子健康记录数据集成，用于登记多样性监测和干预开发。 该提案的目标是利用这些进展，开发三个互补项目， 共同组成了一个多层次的干预，以克服障碍，以不同的登记在急性白血病。在 目的1，开发一个抢先的试验方案审查系统，以识别急性白血病试验设计 使用预测风险评分和社区评估与入学差异相关的元素。在 目的二，建立急性白血病医疗机构的招生多样性绩效反馈界面 在医疗记录中，并进行了试点。在目标3中，注册对等支持移动的应用程序将 为急性白血病患者开发并试用。这些项目的完成将导致全面 开发了多层次干预，有可能可持续地多样化急性白血病试验入组 这将通过一项大型随机试验进行测试。这项工作将同时产生 监测入学多样性和差异的可复制方法 机构和癌症类型。这项研究将辅之以培训， 行为干预发展、基于社区的参与性研究和多层次健康差异 通过正式的课程、讲习班、研讨会和强大的导师团队进行干预， 合作者这项工作将在一家领先的癌症中心进行，该中心有着良好的护理记录 创新和早期职业调查成功。本研究建议和培训计划共同针对 主要研究者的近期目标是成为一名独立的血癌研究者 护理提供不平等和制定干预措施，以改善获得，质量和结果， 边缘化群体。通过建立一个多层次的干预，有可能提高安全性，有效性， 质量，普遍性和社区参与的临床研究，为不同的参与者，这项建议 也符合主要研究者的长期职业目标，即确保血癌护理服务的公平性。