Improving Informed Consent in Childhood Cancer Trials

改善儿童癌症试验的知情同意

• 批准号: 6866462
• 负责人: Eric D. Kodish
• 金额: $ 78.76万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-01-21 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6866462
• 关键词: audiotape; behavioral /social science research tag; clinical research; clinical trials; data collection methodology /evaluation; decision making; human subject; informed consent; leukemia; method development; patient care management; pediatric neoplasm /cancer

DESCRIPTION (provided by applicant): Informed consent requires further study, and pediatric oncology is the ideal context for the conduct of such research. The primary goal of this study is to improve the quality of informed consent for childhood cancer trials. The project will take place as a limited-institution study within the Children's Oncology Group, the single pediatric member of the NCI's Clinical Trials Cooperative Group Program. The long-term objective will be to capitalize on our understanding of consent to yield generalizable findings that can be implemented to improve consent in clinical trials across various diseases and all age groups. The research plan is based on the premise that specific outcome measures and rigorous scientific methodology are required to accurately study the complex interaction that is informed consent. The work accomplished to date has allowed us to refine this methodology, select key outcome measures, and develop rational intervention plans; it is the foundation upon which this competitive renewal proposal is based. The Specific Aims of the project are: 1) To utilize our scientific understanding of the informed consent process in childhood leukemia trials to further develop, test and implement two databased interventions to improve informed consent: a) a physician-directed intervention based on teaching improved management of the informed consent conference, and b) a parent-directed intervention based on the model of anticipatory guidance for informed consent; 2) To conduct a clinical trial to test the effect of each intervention on three specific outcomes: a) parental comprehension of choice and alternative to clinical trial participation, b) parental understanding of randomization, and c) parental participation during the informed consent process as measured by the number and quality of questions asked by parents, and; 3) To determine if either intervention is superior to a control group, and how the two interventions compare to one another. This clinical trial of two rational, data-driven interventions will allow us to act on what we have learned, to determine whether we can improve informed consent.

描述（由申请人提供）：知情同意需要进一步研究，而儿科肿瘤学是进行此类研究的理想背景。这项研究的主要目标是提高儿童癌症试验知情同意的质量。该项目将作为儿童肿瘤学组内的一项有限机构研究进行，该组是 NCI 临床试验合作组计划的唯一儿科成员。长期目标是利用我们对同意的理解来得出可推广的发现，这些发现可用于改善各种疾病和所有年龄组的临床试验中的同意。该研究计划的前提是，需要具体的结果测量和严格的科学方法来准确研究知情同意这一复杂的相互作用。迄今为止完成的工作使我们能够完善这一方法、选择关键结果指标并制定合理的干预计划；这是本次竞争性更新提案的基础。该项目的具体目标是： 1) 利用我们对儿童白血病试验知情同意过程的科学理解，进一步开发、测试和实施两种数据库干预措施，以改善知情同意：a) 基于教学改进知情同意管理的医生指导干预 会议，以及 b) 基于知情同意预期指导模式的家长主导干预； 2) 进行临床试验，测试每种干预措施对三个具体结果的影响：a) 家长对参与临床试验的选择和替代方案的理解，b) 家长对随机化的理解，以及 c) 家长在知情同意过程中的参与情况（通过家长提出的问题的数量和质量来衡量）； 3) 确定任一干预措施是否优于对照组，以及这两种干预措施之间的比较。这项两项理性的、数据驱动的干预措施的临床试验将使我们能够根据所学到的知识采取行动，以确定我们是否可以改善知情同意。