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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要癌症临床试验入组偏倚研究结果中的种族差异限制了普遍性，并且减少了试验提供的新疗法和高质量护理的公平机会。淋巴细胞白血病是一种侵袭性但可治愈的血癌，影响全国 170,000 人，患有这些癌症的黑人和西班牙裔成年人的发病率调整试验入组率是最低的已知的——比白人患者少 85%。这些白血病患者的独特护理模式限制了其效用。现有的、基于社区的入组多样性干预措施：患者需要快速住院治疗及以上一半的人出现在四级转诊中心，其中很大比例的入学情况存在差异。试验设计的可修改因素、提供者授权不足以及患者的犹豫行为似乎发挥了作用最近的政策和数据科学创新在维持这种差异方面发挥了关键作用，现在允许癌症登记。电子健康记录数据集成，用于入学多样性监测和干预措施的制定。该提案的目标是利用这些进步，开发三个互补项目共同构成了克服急性白血病多样化入组障碍的多层次干预措施。目标 1，将开发先发性试验方案审查系统来确定急性白血病试验设计使用预测风险评分和社区评估来确定与入学差异相关的因素。目标2，将构建急性白血病提供者的注册多样性绩效反馈界面在目标 3 中，将推出一个登记同伴支持移动应用程序。为急性白血病患者开发和试点的这些项目的完成将带来全面的结果。开发了多层次干预措施，有可能使急性白血病试验招募持续多样化这项工作将同时进行，并通过大规模随机试验进行测试。监测入学多样性和差异的可复制方法干预评估这项研究将得到培训的补充，以培养相关专业知识。行为干预的发展、基于社区的参与性研究和多层次的健康差异通过正式课程、讲习班、研讨会以及强大的导师团队进行干预这项工作将在一家拥有良好护理服务记录的领先癌症中心内进行。创新和早期职业研究者的成功一起，该研究提案和培训计划的目标是主要研究者的近期目标是成为一名表征血癌的独立研究者护理服务的不平等并制定干预措施以改善护理服务的获取、质量和结果通过建立多层次的干预措施，有可能提高安全性、有效性，该提案针对不同人群的临床研究的质量、普遍性和社区参与也符合主要研究者确保血癌护理服务公平的长期职业目标。