Training Community Nurses and Administrators to Implement Cancer Clinical Trials

培训社区护士和管理人员实施癌症临床试验

基本信息

批准号：
8339193
负责人：
Regina S. Cunningham
金额：
$ 30.61万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-21 至 2017-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8339193
关键词：
Accreditation Address Administrator Adult Adverse event American College of Surgeons Area Award Caring Cities Clinical Research Clinical Trials Code Cognitive Communities Community Hospitals Conduct Clinical Trials Continuing Education Decision Making Development Documentation Drug Industry Educational Curriculum Educational workshop Effectiveness Emotional Enrollment Ethical Issues Ethics Faculty Goals Good Clinical Practice Growth Growth and Development function Home environment Informed Consent Institution Knowledge Learning Maintenance Malignant Neoplasms Mediation Medical Medical Oncology Medical center New York City Nurse Administrator Nurses Nursing Education Nursing Research Nursing Societies Nursing Staff Oncologic Nursing Oncology Nurse Outcome Patient Participation Patients Population Heterogeneity Process Regulation Report (document)Reporting Research Research Activity Research Design Research Infrastructure Research Personnel Research Training Role Science Scientific Advances and Accomplishments Screening procedure Series System Teleconferences Testing Therapeutic Therapeutic Clinical Trial Training Underserved Population United States United States National Institutes of Health Vertebral column Work bench to bedside clinical practice data management design experience interest organizational structure patient population prevent primary outcome programs satisfaction skills

项目摘要

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.

描述（由申请人提供）：临床研究试验是针对癌症的科学进步的支柱。 2010年11月，在全国范围内进行了1,298次国立卫生研究院（NIH）试验。但是，由于缺乏研究基础设施和受研究培训的护士无法从事试验，因此较小的肿瘤学和医疗机构（尤其是社区医院癌症计划（CHCP））受到限制。 2012年美国外科医生学院的CANCERTM（COC）癌症计划标准要求所有CHCP招募2％的患者人群参加临床试验，以维持其认证。目前，美国有525个CHCP具有COC认证。这些机构中的许多几乎没有进行临床试验的经验。拟议的R-25E并没有等待变化n肿瘤学护理教育来满足这一需求，而是通过教育来自智商的社区癌症护士（CCN）和癌症计划管理员（CPA）团队来解决这一培训赤字，以了解如何以道德和安全的方式实施，治疗和评估临床试验的患者。 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可作为培训教师。总体目标：拟议项目的总体目标是增加对COC认可的CHCP的治疗临床试验的患者入学率。这将通过完善和实施课程来实现，从而培训CCN和CPA团队从CHCPS实施和执行临床研究试验。该研究的具体目的是：1）精炼和管理一项课程，该课程将用于卫生CHCP的CCN和CPA，以旨在以道德和安全的方式实施，治疗和评估临床试验的受试者； 2）测试培训研讨会对学员的即时知识和技能的有效性，以及确定受训者的满意度，3），以提供培训，网络机会和继续教育的教育，通过在线讨论委员会和每月的电视转让，最多4个月，以及4个月），以评估组织结构和临床试验活动6、12、12、24个月的培训。公共卫生相关性：拟议的R25E旨在通过在社区癌症护士（CCN）和癌症计划管理员（CPAS）中建立研究特异性知识和技能，以增加美国外科医生学院委员会（COC）认可的社区医院癌症计划（CHCP）的治疗癌症临床试验的患者入学率。该计划的目的是让CCN和CPA团队在临床研究的基本方面接受动手培训，以便他们可以在其机构内实施或增强癌症的临床试验。结果将包括知识，技能和临床研究活动的增长，包括筛查，应计和癌症临床试验患者的维护。