Training Community Nurses and Administrators to Implement Cancer Clinical Trials

描述（由申请人提供）：临床研究试验是抗癌科学进步的支柱。2010年11月，国家卫生研究院在全国范围内进行了1,298项试验。然而，较小的肿瘤和医疗机构——尤其是社区医院癌症项目（CHCPs）——由于缺乏研究基础设施和受过研究培训的护士来参与试验，参与程度有限。2012年美国外科医师学会癌症委员会（CoC）癌症项目标准要求所有chcp必须招募2%的患者参加临床试验，以保持其认证。目前，美国有525家CHCPs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。拟议的R-25E将通过教育社区癌症护士（CCN）和来自CHCPs的癌症项目管理员（CPA）团队如何以道德和安全的方式实施、治疗和评估临床试验患者，来解决这一培训赤字，而不是等待肿瘤护理教育的变化来解决这一需求。这项建议的理由来自五个事实：1)即将到来的CoC认证流程的变化将很快为许多没有准备的机构带来临床试验；2)缺乏具有开展和实施临床研究专业知识的护理人员和其他专业人员；3)缺乏临床研究基本原则的培训机会；4)肿瘤学护士对此类培训的兴趣很高；5)有8位该领域的领导者可以担任培训教师。

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. PUBLIC HEALTH RELEVANCE: The proposed R25E is designed to increase patient enrollment on therapeutic cancer clinical trials at American College of Surgeons Commission on CancerTM (CoC)-accredited Community Hospital Cancer Programs (CHCPs) by building research-specific knowledge and skills among Community Cancer Nurses (CCNs) and Cancer Program Administrators (CPAs). The goal of the program is for teams of CCNs and CPAs to receive hands-on training in fundamental aspects of clinical research so that they can implement or augment cancer clinical trials within their institutions. Outcomes will include knowledge, skills, and growth of clinical research activities including screening, accrual, and maintenance of patients on cancer clinical trials.