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: 10650865
• 负责人: Andrew Hantel
• 金额: $ 25.45万
• 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/10650865
• 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; Disparate; Disparity; Educational Materials; Educational workshop; Electronic Health Record; Elements; Enrollment; Ensure; Equity; Feedback; Focus Groups; Goals; Hematopoietic Neoplasms; Hispanic; Improve Access; Incidence; Incubators; Inequity; 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; Recommendation; Registries; Reporting; Research; Research Personnel; Research Proposals; Research Training; Risk; Safety; Scientist; Services; Social Work; Structure; System; Testing; Training; Work; arm; 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; racial disparity; randomized trial; risk prediction; secondary outcome; stem; success; therapy design; therapy development; tool; trial design; trial enrollment; 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.

项目摘要/摘要 癌症临床试验入学率研究结果的发现，限制了普遍性和 减少对试验提供的新型疗法和高质量护理的公平访问。急性髓样和 淋巴细胞白血病是侵略性但健康的血液癌，在全国范围内影响170,000人，并且 黑人和西班牙裔成年人与这些癌症的发病率调整试验入学率是最低的 已知 - 比白人患者少至85％。这些白血病具有独特的护理模式，可以限制实用性 现有的，基于社区的入学多样性干预措施：患者需要快速的住院治疗和UP 在第四纪转介中心看到一半，那里发生了很大比例的不同入学人数。 试验设计的可修改要素，授权较低和患者的犹豫行为似乎正在发挥 在这种差异的持续性方面的关键作用。最近的政策和数据科学创新现在允许癌症注册表 以及电子健康记录数据集成，用于注册多样性监测和干预开发。 该提案的目的是利用这些进步，开发三个完整的项目 共同完成了一项多层次干预措施，以克服急性白血病潜水员入学的障碍。 AIM 1，将开发先发制体试验协议审查系统，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要素。在 AIM 2，将构建急性白血病提供商的注册多样性绩效反馈接口 在病历中并试行。在AIM 3中，注册同行支持移动应用程序将是 为急性白血病患者开发并试行。这些项目的完成将完全导致 开发的多层次干预措施有可能可持续地多元化急性白血病试验 大规模将通过大型随机试验进行测试。这项工作将简单地产生 可复制方法，用于监视跨越注册多样性和分布干预评估 机构和癌症类型。这项研究将通过培训将培养专业知识来完成 行为干预发展，基于社区的参与研究和多层次健康差异 通过正式课程，讲习班，半手和强大的导师团队的干预措施以及 合作者。这项工作将在一个领先的癌症中心内进行，该中心具有护理交付的记录 创新和早期研究人员的成功。这项研究建议和培训计划共同针对 主要研究者成为表征血液癌的独立研究者的近期目标 护理交付不平等和制定干预措施，以改善访问，质量和结果 边缘化群体。通过创建一种多层次干预措施，该干预有可能提高安全性，效率， 该建议 还与主要研究者的长期职业目标保持一致，即确保血液癌护理中的公平性。

项目成果

Use, variability, and justification of eligibility criteria for phase II and III clinical trials in acute leukemia.

急性白血病 II 期和 III 期临床试验资格标准的使用、变异性和合理性。

• DOI: 10.3324/haematol.2023.283723
• 发表时间: 2024
• 期刊: Haematologica
• 影响因子: 10.1
• 作者: Hantel,Andrew;Luskin,MarliseR;Khan,Irum;Warner,Elizabeth;Patel,AnandA;Walsh,ThomasP;DeAngelo,DanielJ;Lathan,ChristopherS;Abel,GregoryA
• 通讯作者: Abel,GregoryA

Race/ethnic associations with comprehensive cancer center access and clinical trial enrollment for acute leukemia.

种族/民族与综合癌症中心准入和急性白血病临床试验注册的关联。

• DOI: 10.1093/jnci/djae067
• 发表时间: 2024
• 期刊: Journal of the National Cancer Institute
• 作者: Hantel,Andrew;Brunner,AndrewM;Plascak,JesseJ;Uno,Hajime;Varela,JuanC;Luskin,MarliseR;Rebbeck,TimothyR;Stone,RichardM;Lathan,ChristopherS;DeAngelo,DanielJ;Abel,GregoryA
• 通讯作者: Abel,GregoryA

Sociodemographic associations with uptake of novel therapies for acute myeloid leukemia.

• DOI: 10.1038/s41408-023-00964-x
• 发表时间: 2023-12-21
• 期刊: BLOOD CANCER JOURNAL
• 影响因子: 12.8
• 作者: Hantel, Andrew;Cernik, Colin;Uno, Hajime;Walsh, Thomas P.;Calip, Gregory S.;DeAngelo, Daniel J.;Lathan, Christopher S.;Abel, Gregory A.
• 通讯作者: Abel, Gregory A.

Establishing and Defining an Approach to Climate Conscious Clinical Medical Ethics.

建立和定义气候意识临床医学伦理方法。

• DOI: 10.1080/15265161.2024.2337418
• 发表时间: 2024
• 期刊: The American journal of bioethics : AJOB
• 作者: Hantel,Andrew;Marron,JonathanM;Abel,GregoryA
• 通讯作者: Abel,GregoryA

Shifting from Equality toward Equity: Addressing Disparities in Research Participation for Clinical Cancer Research.

从平等转向公平：解决临床癌症研究的研究参与差异。

• DOI: 10.1086/728144
• 发表时间: 2024
• 期刊: The Journal of clinical ethics
• 作者: Warner,Elizabeth;Marron,JonathanM;Peppercorn,JeffreyM;Abel,GregoryA;Hantel,Andrew
• 通讯作者: Hantel,Andrew