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

• 批准号: 8726348
• 负责人: Regina S. Cunningham
• 金额: $ 29.88万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 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/8726348
• 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 Workshop; 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; Series; System; Teacher Professional Development; 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; screening; skills

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.

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，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，由于缺乏研究基础设施和受过研究培训的护士来进行试验，较小的肿瘤学和医疗机构——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 招募 2% 的患者群体参加临床试验，以维持其认证。目前美国有 525 个 CHCP 拥有 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 CHCP 的社区癌症护士 (CCN) 和癌症项目管理员 (CPA) 团队如何以道德和安全的方式实施、治疗和评估临床试验中的患者来解决这一培训缺陷，而不是等待肿瘤护理教育的变化来满足这一需求。该提案的理由基于五个事实：1) CHCP 的 CoC 认证流程即将发生的变化将很快为许多未做好准备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) 临床研究基本原理的培训机会很少，4) 肿瘤科护士对此类培训的兴趣很高，5) 该领域的八名领导者 可以担任培训教师。 总体目标：拟议项目的总体目标是增加 CoC 认可的 CHCP 治疗性临床试验的患者注册人数。这将通过完善和实施课程来培训 CHCP 的 CCN 和 CPA 团队实施和执行临床研究试验来实现。该研究的具体目标是：1）完善和管理课程，用于培训来自 CHCP 的 CCN 和注册会计师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) 测试培训研讨会对受训者即时知识和技能的有效性，并确定受训者满意度，3) 在培训结束后，通过在线讨论板和每月电话会议为受训者提供长达 4 个月的交流机会和继续教育，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。