The ECOG-ACRIN SUPPORT Trial: Multilevel Intervention to Improve Diverse Enrollment in Cancer Clinical Trials

ECOG-ACRIN 支持试验：多层次干预以改善癌症临床试验的多样化入组情况

• 批准号: 10705107
• 负责人: Elyse R. Park
• 金额: $ 69.03万
• 依托单位: ECOG-ACRIN MEDICAL RESEARCH FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10705107
• 关键词: Address; Advocate; American College of Radiology Imaging Network; Awareness; Black Populations; Black race; Cancer Control; Cancer Patient; Chicago; Clinical; Clinical Research; Clinical Trials; Communities; Community Clinical Oncology Program; Data; Eastern Cooperative Oncology Group; Enrollment; Equity; Evaluation; Head and Neck Cancer; Health; Healthcare; Hematologic Neoplasms; Hispanic; Hybrids; Infrastructure; Intervention; Knowledge; Latino; Latino Population; Libraries; Link; Malignant Neoplasms; Malignant neoplasm of thorax; Medical; Medicine; Multiple Myeloma; National Cancer Institute; Oncologist; Oncology; Outcome; Output; Participant; Patients; Phase; Physicians; Population; Population Heterogeneity; Process; Provider; Randomized; Research; Research Personnel; Resources; Site; Testing; Therapeutic Trials; Thinking; Training; Translations; Underrepresented Populations; Urogenital Cancer; Work; anticancer research; base; cancer care; cancer clinical trial; cancer heterogeneity; cancer prevention; care delivery; clinical research site; clinical trial enrollment; community engagement; design; diversity and inclusion; effectiveness evaluation; effectiveness/implementation trial; ethnic minority; experience; falls; forging; health disparity; health equity; health inequalities; implementation determinants; implementation evaluation; implementation science; improved; innovation; insight; leukemia; literacy; member; minority communities; minority patient; novel; parity; participant enrollment; patient navigation; patient oriented; patient-level barriers; precision medicine; primary care clinician; primary outcome; racial minority; recruit; secondary outcome; social health determinants; success; support tools; tool; virtual

ABSTRACT Inadequate diversity in clinical trials is widely recognized as a significant contributing factor to health disparities experienced by racial/ethnic minorities and other diverse populations in the US. This lack of parity calls for urgent initiatives aimed at increasing diversity in order to support more equitable representation in clinical research and bring the benefits of advances in healthcare forged by clinical research equitably to all. National Cancer Institute (NCI) supported clinical trials (CTs) are key drivers of innovations in cancer care; however racial/ethnic minorities, and Black and Latino populations in particular, are underrepresented in NCI-supported CTs and thus not able to fully benefit from cutting edge treatments and precision medicine. CT participation among Black and Latino populations continues to fall short and the multitude of structural, clinical, physician, and patient barriers warrant multilevel interventions to enhance referral and enrollment of Black and Latino patients to NCI-supported CTs. The ECOG-ACRIN Cancer Research Group (EA), as an NCORP Research Base, has engaged community providers and researchers through a robust research portfolio that spans Cancer Control, Cancer Prevention, and Cancer Care Delivery. We propose to leverage the collective resources of the EA, our team’s decades of work on improving diversity in clinical trials, and our foundational work in patient navigation and CT research literacy tools to create and evaluate an ECOG-ACRIN Trial SUPPORT Toolkit (SUPPORT intervention) that aims to improve Black and Latino referral and enrollment in active NCI-supported therapeutic trials in head and neck, thoracic, and genitourinary cancers, and leukemia and myeloma. The multilevel EA SUPPORT intervention consists of a CT research literacy tool and CT Resource Navigators based at EA who will interface with patients, providers, and community oncology site staff to improve referral and enrollment of Black and Latino patients to CTs. Our specific aims are to: 1) Conduct preliminary assessments and refine the EA SUPPORT intervention with focus on community representation and input. 2) Conduct a Hybrid Type 1 cluster-randomized, roll-out effectiveness-implementation trial in 10 NCORP community oncology practice sites (with N= 500 Black and Latino patients with cancer) to evaluate the effectiveness of the EA SUPPORT intervention in improving Black and Latino patient referral and enrollment to NCI-supported CTs (primary outcomes) and participant and provider awareness and knowledge of CTs (secondary outcomes) while assessing implementation factors. 3) With the CUSP2CT Data, Evaluation, and Coordinating Center, conduct final site evaluation and disseminate the SUPPORT intervention to NCORP community oncology sites, research bases, and affiliated trial networks. Our collaborative infrastructure and EA SUPPORT multilevel intervention will shift the current clinical trial research base referral and enrollment paradigm and directly remove multiple levels of barriers through innovations in CT navigation and CT research literacy tools.

抽象的 临床试验多样性不足被广泛认为是造成健康差异的一个重要因素 美国的少数种族/族裔和其他不同人群都经历过这种情况。这种缺乏平等的现象迫切需要 旨在增加多样性的举措，以支持临床研究和治疗中更公平的代表性 让所有人公平地享受临床研究带来的医疗保健进步的好处。美国国家癌症研究所 (NCI) 支持的临床试验 (CT) 是癌症治疗创新的关键驱动力；无论种族/民族 少数族裔，尤其是黑人和拉丁裔人口，在 NCI 支持的 CT 中代表性不足，因此 无法充分受益于尖端治疗和精准医学。黑人和黑人的 CT 参与 拉丁裔人口数量持续不足，并且存在多种结构性、临床、医生和患者障碍 需要采取多层次干预措施，以加强黑人和拉丁裔患者向 NCI 支持的转诊和登记 CT。 ECOG-ACRIN 癌症研究小组 (EA) 作为 NCORP 研究基地，吸引了社区的参与 通过涵盖癌症控制、癌症预防、 和癌症护理服务。我们建议利用 EA 的集体资源，我们团队数十年的经验 致力于提高临床试验的多样性，以及我们在患者导航和 CT 研究方面的基础工作 用于创建和评估 ECOG-ACRIN 试验支持工具包（支持干预）的读写工具，其目标是 改善黑人和拉丁裔在 NCI 支持的头颈治疗试验中的转诊和登记， 胸部和泌尿生殖系统癌症，以及白血病和骨髓瘤。多层次 EA SUPPORT 干预 由 CT 研究素养工具和位于 EA 的 CT 资源导航员组成，他们将与患者互动， 提供者和社区肿瘤学站点工作人员，以改善黑人和拉丁裔患者的转诊和登记 CT。我们的具体目标是： 1) 进行初步评估并完善 EA SUPPORT 干预措施 重点关注社区代表和意见。 2) 进行混合类型 1 集群随机、推出 在 10 个 NCORP 社区肿瘤​​学实践地点（N = 500 名黑人和 拉丁裔癌症患者）评估 EA SUPPORT 干预对改善黑人的有效性 拉丁裔患者转诊和登记至 NCI 支持的 CT（主要结果）以及参与者和提供者 在评估实施因素时提高对 CT（次要结果）的认识和了解。 3）随着 CUSP2CT数据、评估和协调中心，进行最终现场评估并传播 支持对 NCORP 社区肿瘤​​学站点、研究基地和附属试验网络进行干预。我们的 协作基础设施和 EA SUPPORT 多层次干预将改变当前的临床试验研究 基础转诊和注册范式，并通过 CT 创新直接消除多层障碍 导航和 CT 研究素养工具。