CORE--ADHERENCE CORE

核心——坚持核心

• 批准号: 6102267
• 负责人: JAN R ATWOOD
• 金额: $ 34.62万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-03-01 至 2000-09-13
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6102267
• 关键词: behavioral /social science research tag; biomedical facility; cancer prevention; cancer risk; colon neoplasms; health behavior; human subject; neoplasm /cancer education; nutrition education; nutrition related tag; psychometrics; therapy compliance

Colorectal cancer remains the second leading cause of cancer death in the United States. Recent advances in adjuvant therapy are just beginning to impact the 5-year survival rates. As a result, early detection and especially dietary and novel chemopreventive strategies represent the best hope to significantly decrease the mortality rates for this disease. Adherence to clinical trials is an area of increasing concern due in part to the cost involved in conducting community based clinical trials. There is increasing interest in identifying those factors that may affect adherence and are amenable to change, as well as developing methods to enhance adherence in clinical trials. There is evidence showing that adherence to long term clinical trials is achievable. However, the complexity of maintaining long term changes, particularly dietary changes should be recognized. The Adherence Core is a service resource which pools expertise and materials to support the three projects. Subjects in these clinical studies are 40-80 years old with a history of colorectal adenomatous polyps. The aims of the core are: 1. to monitor and evaluate adherence to study procedures, 2. to provide the nurse interveners with guidelines, consulting and training on promoting participant adherence to study protocols, 3. to develop strategies to reduce barriers associated with adherence problems in clinical trials, 4. to develop and produce materials (e.g. newsletters) and implement procedures (e.g. general adherence intervention) to enhance participant adherence to study procedures, 5. to develop, produce and distribute various written materials educating the participants about potential side effects and ways to manage them, 6. to optimize subject recruitment strategies to reduce attrition, 7. to develop instruments to identify behavioral factors that may influence/predict attrition and/or adherence, and 8. to educate participants about cancer, its etiology and prevention, with particular emphasis on colon cancer. Core outcomes include promotion of adherence, evaluation of the effectiveness of the General Adherence Enhancement intervention, the Problem-Solving remedial intervention for non-adherers, the Attrition Prevention intervention, and generation of qualitative data on problems experienced by participants in large clinical trials, as well as methods to solve them.

结直肠癌仍然是癌症死亡的第二大原因 美国。辅助治疗的最新进展仅 开始影响 5 年生存率。结果，早 检测，特别是饮食和新型化学预防策略 代表了显着降低死亡率的最大希望 对于这种疾病。 遵守临床试验是一个日益受到关注的领域，因为 部分费用涉及进行基于社区的临床试验。 人们越来越有兴趣确定那些可能导致 影响坚持并愿意改变，以及发展 提高临床试验依从性的方法。有证据 表明坚持长期临床试验是可以实现的。 然而，维持长期变化的复杂性，特别是 应认识到饮食变化。 Adherence Core 是一种服务资源，汇集了专业知识和 为这三个项目提供支持材料。这些临床研究对象 研究对象为40-80岁有结直肠腺瘤病史 息肉。核心目标是： 1. 监测和评估依从性 研究程序，2. 向护士干预人员提供 促进参与者依从性的指南、咨询和培训 研究协议，3.制定减少障碍的策略 4. 与临床试验中的依从性问题相关，开发和 制作材料（例如新闻通讯）并实施程序（例如 一般依从性干预）以增强参与者的依从性 5. 制定、制作和分发各种书面学习程序 教育参与者潜在副作用的材料和 6. 优化受试者招募策略 减少人员流失，7. 开发工具来识别行为 可能影响/预测流失和/或依从性的因素，以及 8. 教育参与者有关癌症、其病因和预防的知识 特别强调结肠癌。 核心成果包括促进依从性、评估 一般依从性增强干预措施的有效性 针对不遵守者的问题解决补救干预，即“自然流失” 预防干预以及生成有关问题的定性数据 大型临床试验参与者的经验以及方法 来解决它们。