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.

项目概要-参与者参与股 PEU将负责直接参与者参与，以招募患者进入华盛顿大学 (WU)PE-CGS程序。在PIs Fields和Drake的指导下，我们将利用调查员和 机构的专门知识，以直接解决癌症登月蓝带小组的建议，“建立 一个直接与患者接触的网络”。我们将优先考虑8个与PEU具体相关的领域 目的：（1）识别;（2）联系;（3）同意参与者;（4）获得肿瘤/正常样本和临床/Meta分析。 数据;（5）创建和前瞻性维护患者、标本和正在进行的治疗数据;（6）报告研究 研究结果直接研究参与者使用尖端，创新，信息驱动的方法， 利用独特的伙伴关系;（7）引导患者通过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， 根据对参与者的前瞻性研究，不断反复完善全方案的协议。 为了在这七个与癌症登月使命一致的领域取得成功，我们需要新颖的 参与的范例。WU-PE-CGS已经开发了几种创新方法， 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 在直接与患者合作伙伴（PP）合作方面具有丰富经验的患者倡导团体（PAG） 在推进癌症护理：胆管癌基金会（CCF），抗击结直肠癌（FCRC），和 多发性骨髓瘤研究基金会（MMRF）。第二，我们将利用我们的机构优势， 直接解决RFA在基因组学特征和患者参与方面的知识缺口， 研究不足的肿瘤类型（胆管癌[CHOL]）和少数研究不足的癌症 人群（50岁以下非洲裔美国人的结直肠癌[CRC-AA<50]和50岁以下非洲裔美国人的多发性骨髓瘤[CRC-AA<50]） 非裔美国人[MM-AA]）。第三，我们将采用双向、实时、信息驱动的方法， 与EOU互动，以评估和反复完善我们的计划，以确保WU-PE-CGS最佳 识别、登记、评估并与参与者互动。 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，即“直接招募 患者参与.以促进参与研究，并确保患者得到尊重和获得 研究企业”高度优先“接触少数民族和服务不足的人口”。我们的伙伴关系 通过PAG和PP，利用研究者和机构专业知识，遵守PCRI规则，以及 正在进行的方法改进将导致对广泛的癌症类型进行有影响力的研究。