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

Empact第二阶段的目标是增加招募和留住少数族裔到 通过久负盛名的Empact财团并与 美国癌症协会，其最终目标是减少与癌症相关的健康差距。 将采用两项战略来实现这一目标：a)采取教育和培训办法，实施 通过基于网络的模块；和b)干预方法，将建立患者导航和 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.建立网络门户：a)包括为调查人员定制的基于网络的培训模块， 研究人员、推荐医生和患者导航员；b)提供招聘和 保留；以及c)充当通信和信息枢纽，以消除已查明的障碍 在治疗癌症临床试验中招募和保留少数族裔。 2.实施和评估患者导航计划，旨在增加招聘和留住 少数族裔患者进入治疗癌症临床试验。 3.在五个区域每个地点设立和试行1)临床试验监察员 1)执行和评估少数群体应计利润标准化实时跟踪系统的使用情况 治疗性临床试验和b)提供对患者导航计划的监督和评估c)开发 以及在项目第3-5年试行基于证据的招聘和留用模式。 拟议的具体目标是基于对障碍的定性和定量评估的结果。 以及少数族裔招募和保留到癌症临床试验中的促进者。这些评估是 由Empact财团在所有五个地点实施两年，并遵循概念性 强调障碍和促进者出现的多个层面的框架。

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.