Participant Engagement Unit

参与者参与单元

• 批准号: 10294014
• 负责人: Ryan C Fields
• 金额: $ 56.35万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10294014
• 关键词: Address; Adherence; Advanced Malignant Neoplasm; African American; Age; Archives; Area; Biopsy; Caring; Cholangiocarcinoma; Clinical; Clinical Trials Database; Colorectal Cancer; Communication; Consent; Data; Databases; Enrollment; Ensure; Evaluation; Excision; Foundations; Future; Genome; Genomics; Goals; Hand; Informatics; Investigation; Knowledge; Malignant Neoplasms; Metadata; Methodology; Methods; Minority; Minority Groups; Mission; Multiple Myeloma; Participant; Pathologist; Patients; Physicians; Process; Prospective Studies; Protocols documentation; Recommendation; Reporting; Research; Research Personnel; Sampling; Specimen; Techniques; Therapeutic; Time; Underserved Population; Universities; Update; Vision; Washington; Work; base; cancer care; cancer genomics; cancer health disparity; cancer type; design; experience; fighting; improved; individual patient; innovation; interest; novel; patient advocacy group; patient engagement; programs; prospective; recruit; success; tumor

PROJECT SUMMARY – PARTICIPANT ENGAGEMENT UNIT (PEU) The PEU will be responsible for direct participant engagement to enroll patients into the Washington University (WU) PE-CGS program. Under the direction of PIs Fields and Drake, we will leverage investigator and institutional expertise to directly address the Cancer Moonshot Blue Ribbon Panel recommendation to “establish a network for direct patient engagement”. We will prioritize 8 areas that are directly tied to the PEU Specific Aims: (1) identify; (2) contact; and (3) consent participants; (4) obtain tumor/normal samples and clinical/meta data; (5) create and prospectively maintain patient, specimen, and ongoing treatment data; (6) report research findings directly to study participants using cutting-edge, innovative, informatics-driven methodologies that leverage unique partnerships; (7) guide patients through the “flow” of the WU-PE-CGS program, providing oversight of program-wide integration; and (8) bi-directionally interact with the other WU-PE-CGS “Units” for ongoing, iterative refinement of program-wide protocols based on prospective study of participants. To achieve success in these seven areas that is in-line with the Cancer Moonshot mission, we need novel paradigms for engagement. The WU-PE-CGS has developed several innovative approaches following our overall mission to “develop, implement, evaluate, and modify”. First, we have partnered with three world-class patient advocacy groups (PAGs) that have significant experience in working directly with patient-partners (PPs) in advancing cancer care: The Cholangiocarcinoma Foundation (CCF), Fight Colorectal Cancer (FCRC), and The Multiple Myeloma Research Foundation (MMRF). Second, we will leverage our institutional strengths to directly address this RFA's stated knowledge gaps of genomically characterizing and engaging patients with understudied tumor types (cholangiocarcinoma [CHOL]) and cancers that are understudied in minority populations (colorectal cancer in African Americans under the age of 50 [CRC-AA<50] and multiple myeloma in African Americans [MM-AA]). Third, we will employ bi-directional, real-time, informatics-driven methods to interact with the EOU to evaluate and iteratively refine our program to ensure that the WU-PE-CGS optimally identifies, enrolls, evaluates, and interacts with the participants. The innovative and impactful aims of the PEU directly address the Cancer Moonshot goals of “enlisting direct patient engagement…to facilitate participation in research and ensure patients are respected and have access to the research enterprise” with a high priority “to reach minority and underserved populations”. Our partnerships with PAGs and PPs, leveraging of investigator and institutional expertise, adherence to PCORI rubrics, and ongoing methodological refinement will result in impactful research across a broad group of cancer types.

项目摘要 – 参与者参与单元 (PEU) PEU 将负责直接参与者参与以将患者纳入华盛顿大学 (WU) PE-CGS 计划在 PI Fields 和 Drake 的指导下，我们将利用研究者和 机构专业知识直接解决癌症登月蓝丝带小组的建议“建立 我们将优先考虑与 PEU 具体直接相关的 8 个领域。 目的：(1) 识别；(2) 接触；(3) 同意参与者；(4) 获取肿瘤/正常样本和临床/元数据 数据；(5) 创建并前瞻性维护患者、样本和正在进行的治疗数据； 使用尖端、创新、信息学驱动的方法直接向研究参与者提供研究结果 利用独特的合作伙伴关系；(7) 指导患者完成 WU-PE-CGS 计划的“流程”，提供 监督整个计划的整合；(8) 与其他 WU-PE-CGS“单位”进行双向互动 基于前瞻性研究对整个计划范围内的协议进行持续、迭代的完善。 为了在符合癌症登月任务的这七个领域取得成功，我们需要新颖的 WU-PE-CGS 遵循我们的建议，开发了多种创新方法。 总体使命是“开发、实施、评估和修改”。首先，我们与三个世界级的公司合作。 患者倡导团体 (PAG) 在直接与患者合作伙伴 (PP) 合作方面拥有丰富的经验 推进癌症治疗：胆管癌基金会 (CCF)、抗击结直肠癌 (FCRC) 和 其次，多发性骨髓瘤研究基金会（MMRF）将利用我们的机构优势。 直接解决该 RFA 所规定的基因组特征和患者参与方面的知识差距 未充分研究的肿瘤类型（胆管癌 [CHOL]）和少数未充分研究的癌症 人群（50 岁以下非裔美国人的结直肠癌 [CRC-AA<50] 和多发性骨髓瘤 非裔美国人[MM-AA]）第三，我们将采用双向、实时、信息学驱动的方法来 与 EOU 互动，评估并迭代完善我们的计划，以确保 WU-PE-CGS 达到最佳效果 识别、注册、评估参与者并与参与者互动。 PEU 的创新和有影响力的目标直接解决了癌症登月计划的目标“招募直接 患者参与……促进参与研究并确保患者受到尊重并有机会参与 我们的合作伙伴关系的首要任务是“惠及少数族裔和服务不足的人群”。 与 PAG 和 PP 合作，利用研究者和机构的专业知识，遵守 PCORI 规则，以及 持续的方法学完善将在广泛的癌症类型中产生有影响力的研究。