Training Community Nurses and Administrators to Implement Cancer Clinical Trials

描述(申请人提供)：临床研究试验是抗癌科学进步的支柱。2010年11月，美国国立卫生研究院(NIH)在全国范围内进行了1,298项试验。然而，规模较小的肿瘤学和医疗机构--特别是社区医院癌症计划(CHCP)--的参与受到限制，因为缺乏研究基础设施和受过研究培训的护士来参与试验。2012年美国外科学会癌症委员会(CoC)癌症计划标准要求所有CHCP登记2%的患者参加临床试验，以保持他们的认证。目前，美国有525个CHCP获得了COC认证。这些机构中的许多几乎没有进行临床试验的经验。与其等待肿瘤学护理教育的变化来满足这一需求，拟议的R-25E将通过教育社区癌症护士(CCN)和癌症项目管理员(CPA)团队如何以道德和安全的方式在临床试验中实施、治疗和评估患者来解决这一培训不足。这项建议的理由来自五个事实：1)CHC的COC认证程序即将发生的变化将很快给许多没有准备的机构带来临床试验；2)缺乏护理人员和其他具有进行和实施临床研究专业知识的专业人员；3)临床研究基本原理的培训机会很少；4)肿瘤科护士对这种培训兴趣很高；5)该领域的8名领导者可以作为培训教师。 总体目标：拟议项目的总体目标是在CoC认证的CHCP中增加患者参加治疗临床试验的人数。这将通过完善和实施一项课程来实现，以培训来自CHCP的CCN和CPA团队实施和执行临床研究试验。这项研究的具体目的是：1)完善和管理一个课程，用于培训CHCP的CCNS和CPA如何以道德和安全的方式实施、处理和评估关于临床试验的主题；2)测试关于受训人员即时知识和技能的培训讲习班的有效性，并确定受训人员的满意度；3)在培训结束后，通过在线讨论委员会和每月举行的电话会议，为受训人员提供联网机会和持续教育，最长可达4个月；以及4)在完成培训后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.