Enhancing Minority Participation in Clinical Trials (EMPaCT):Phase II

加强少数人对临床试验的参与 (EMPACT)：第二阶段

• 批准号: 8334499
• 负责人: MONA N. FOUAD
• 金额: $ 97.03万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-19 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8334499
• 关键词: Address; American Cancer Society; Clinical Trials; Communication; Development; Evaluation; Goals; Individual; Internet; Intervention; Malignant Neoplasms; Minority; Minority Groups; Modeling; NCI-Designated Cancer Center; Online Systems; Patients; Phase II Clinical Trials; Physicians; Research; Research Personnel; Resources; Site; Support System; System; Therapeutic; Therapeutic Clinical Trial; Time; Training; Training and Education; Work; base; design; evidence base; health disparity; improved; novel; programs

The objective of EMPaCT Phase II is to increase recruitment and retention of racial/ethnic minorities into therapeutic clinical trials through the well-established EMPaCT consortium and in partnership with the American Cancer Society, with the ultimate goal of reducing cancer-related health disparities. Two Strategies will be employed to achieve this objective: a) education and training approach, implemented through Web-based modules; and b) intervention approach, which will establish a patient navigation and clinical trial support system. These strategies will be pursued through the following specific aims: 1. Establish a Web-portal that: a) includes Web-based training modules customized for investigators, research staff, referring physicians, and patient navigators; b) provides resources for recruitment and retention; and c) serves as communications and information hub, in order to address identified barriers to recruitment and retention of minorities into therapeutic cancer clinical trials. 2. Implement and evaluate a patient navigation program designed to increase recruitment and retention of minority patients into therapeutic cancer clinical trials. 3. Development and pilot implementation of a) of clinical trials ombudsman at each of the five regional sites 1 to a) implement and evaluate the use of a standardized real-time tracking system of minority accrual into therapeutic clinical trials and b) to provide oversight and evaluation of patient navigation program c) develop and pilot evidence based recruitment and retention models in project years 3-5. The proposed specific aims are based on the findings of qualitative and quantitative assessments of barriers and facilitators of minority recruitment and retention into cancer clinical trials. These assessments were implemented by the EMPaCT consortium over 2 years across all five sites and were guided by a conceptual framework that highlights the multiple levels upon which barriers and facilitators occur.

EMPaCT第二阶段的目标是增加种族/族裔少数群体的招聘和保留， 通过成熟的EMPaCT联盟并与 美国癌症协会，其最终目标是减少与癌症有关的健康差距。 为实现这一目标，将采用两项战略： 通过基于网络的模块;和B）干预方法，将建立患者导航， 临床试验支持系统。 这些战略将通过以下具体目标来实施： 1.建立一个门户网站，其中：a）包括为调查人员定制的基于网络的培训模块， 研究人员、转诊医生和患者导航员; B）提供招聘资源和 保留;以及c）作为沟通和信息中心，以解决已查明的障碍， 招募和保留少数群体参与治疗癌症的临床试验。 2.实施并评估旨在增加招募和保留患者的患者导航计划 少数民族患者进入治疗癌症的临床试验。 3. a）在五个区域研究中心设立临床试验监察员，并进行试点 1至a）实施和评价使用标准化的少数族裔应计制实时跟踪系统， 治疗性临床试验和B）提供对患者导航程序的监督和评价c）开发 在项目第3-5年试行循证征聘和留用模式。 拟议的具体目标是根据对障碍进行定性和定量评估的结果提出的 和少数族裔招募和保留到癌症临床试验的促进者。这些评估 由EMPaCT联盟在所有五个地点实施了两年多，并以概念 该框架强调了障碍和促进因素发生的多个层面。