Training Community Nurses and Administrators to Implement Cancer Clinical Trials

描述（由申请人提供）：临床研究试验是对抗癌症的科学进步的支柱。2010年11月，全国范围内进行了1，298项国立卫生研究院（NIH）试验。然而，由于缺乏研究基础设施和接受过研究培训的护士来参与试验，小型肿瘤学和医疗机构--尤其是社区医院癌症项目（CHCP）--的参与受到限制。2012年美国外科医生学会癌症委员会（CoC）癌症计划标准要求所有CHCP在临床试验中招募2%的患者，以保持其认证。目前，美国有525家CHCP获得了CoC认证。其中许多机构几乎没有进行临床试验的经验。而不是等待肿瘤护理教育的变化来解决这一需求，拟议的R-25 E将通过教育社区癌症护士（CCN）和癌症项目管理员（CPA）团队来解决这一培训不足问题，这些团队来自CHCP，他们将学习如何以道德和安全的方式实施，治疗和评估临床试验中的患者。这一建议的理由来自五个事实：1）即将到来的对CHCP的CoC认证过程的改变将很快给许多没有准备好的机构带来临床试验，2）缺乏护理人员和其他具有开展和实施临床研究专业知识的专业人员，3）缺乏关于临床研究基本原则的培训机会，4）肿瘤科护士对这种培训的兴趣很高，5）该领域的八位领导人可担任培训教师。 总体目标：拟议项目的总体目标是增加CoC认证的CHCP治疗临床试验的患者入组。这将通过完善和实施课程来实现，以培训来自CHCP的CCN和CPA团队实施和执行临床研究试验。本研究的具体目的是：1）完善和管理一个课程，用于培训来自CHCP的CCN和CPA，了解如何以道德和安全的方式实施、治疗和评估临床试验受试者; 2）测试培训班对受训者的直接知识和技能的有效性，并确定受训者的满意度，3）在培训后，通过在线讨论板和每月电话会议为学员提供网络机会和继续教育，持续时间长达4个月，以及4）在培训完成后6、12和24个月评估组织结构和临床试验活动。

DESCRIPTION (provided by applicant): Clinical research trials are the backbone of scientific advances against cancer. In November 2010, 1,298 National Institutes of Health (NIH) trials were taking place nationwide. However, smaller oncology and medical institutions - especially Community Hospital Cancer Programs (CHCPs) - are limited in participation due to the lack of research infrastructure and research-trained nurses to work on the trials. The 2012 American College of Surgeons Commission on CancerTM (CoC) Cancer Program Standards require all CHCPs to enroll 2% of their patient population on clinical trials in order to maintain their accreditation. Currently 525 CHCPs in the United States have CoC accreditation. Many of these institutions have little to no experience conducting clinical trials. Rather than wait for changes n oncology nursing education to address this need, the proposed R-25E will address this training deficit by educating Community Cancer Nurse (CCN) and Cancer Program Administrator (CPA) teams from CHCPs on how to implement, treat and assess patients on clinical trials in an ethical and safe manner. The rationale for this proposal derives from five facts: 1) upcoming changes in the CoC accreditation process for CHCPs will soon bring clinical trials to many unprepared institutions, 2) nursing personnel and other professionals with expertise in conducting and implementing clinical research are lacking, 3) training opportunities on the basic principles of clinical research are scarce, 4) interest among oncology nurses in such training is high, and 5) eight leaders in the field are available to serve as training faculty. Overarching Goal: The overarching goal of the proposed project is to increase patient enrollment on therapeutic clinical trials at CoC-accredited CHCPs. This will be accomplished by refining and implementing a curriculum to train CCN and CPA teams from CHCPs to implement and execute clinical research trials. The specific aims of the study are: 1) to refine and administer a curriculum that will be used to train CCNs and CPAs from CHCPs on how to implement, treat and assess subjects on clinical trials in an ethical and safe manner; 2) to test the effectiveness of the training workshop on immediate knowledge and skills of the trainee, as well as to determine trainee satisfaction, 3) to provide, following the training, networking opportunities and continuing education for trainees through an online Discussion Board and monthly teleconferences for up to 4 months, and 4) to assess organizational structure and clinical trials activities 6, 12, and 24 months after completion of the training.