Informed Consent in Pediatric Phase I Cancer Trials

儿科 I 期癌症试验的知情同意书

• 批准号: 7882678
• 负责人: Eric D. Kodish
• 金额: $ 70.75万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-04 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7882678
• 关键词: Bioethics; Child; Child Care; Child health care; Childhood; Clinic; Clinical Trials; Code; Communication; Comprehension; Consent; Data; Data Set; Decision Making; Diagnosis; Family; Foundations; Goals; Informed Consent; Intervention; Interview; Malignant Childhood Neoplasm; Malignant Neoplasms; Methodology; Methods; Motivation; Nature; North America; Palliative Care; Parents; Phase; Phase I Clinical Trials; Population; Process; Questionnaires; Refractory; Research; Research Personnel; Shock; Solid; Suggestion; Voice; Work; base; design; digital; experience; hospice environment; improved; member; outcome forecast; parental influence; programs; symposium

DESCRIPTION (provided by applicant): The primary goal of this research is to understand communication, comprehension and decision-making in Phase I childhood cancer trials. The project will take place at 6 of the most active Phase I pediatric programs in North America, with coordination, data entry and analysis at the Cleveland Clinic Foundation's Department of Bioethics. The methods employed will include direct observation, digital recording, and coding of informed consent conferences to provide valuable data on what actually transpires during the discussions, as well as parent and older child interviews to determine understanding and decision-making and clinician questionnaires to gain their perspectives. The Specific Aims are: 1) Generate and analyze qualitative and quantitative data that will inform scientific understanding of the process of informed consent for Phase I clinical trials in childhood cancer. We will examine the way that Phase I trials are actually presented, whether and how alternatives like hospice/palliative care are introduced, and what parents and older children understand after this communication process. We will discover how the communication process influences parental comprehension and decision-making regarding trial participation and how clinician-investigator perspectives may vary from the understanding of parents and older children. 2) Describe similarities and differences between Phase I and Phase III pediatric cancer informed consent by examining variables that influence clinical trial communication, comprehension, and decisions in these two populations. We will accomplish this aim by comparing Phase I findings on communication, comprehension, and decision-making with findings from our previous work on the informed consent process in Phase III pediatric cancer trials. This comparison is scientifically important because children who are Phase I candidates have a very poor prognosis and their parents are no longer naive or in shock after diagnosis. We anticipate that these contextual differences will have a major impact on the nature of the communication and that contrasting our findings with the Phase III data set will enhance understanding of Phase I consent. 3) Assemble a Parent Advisory Group on Informed Consent (PAGIC) to help us interpret the data we collect and to provide suggestions based on the data for interventions that are rationally designed to improve informed consent for Phase I pediatric cancer trials. This 10 member panel will be comprised of experienced Phase I parents who participated in the observation/interview phase of this study and will provide an authentic stakeholder voice to our understanding of the results and their implications. Phase I clinical trials are a critical part of efforts to improve the health of children, and investigators have an important responsibility to communicate effectively during the informed consent process. The long-term objective of this study will be to improve care for children with refractory cancer and their families by developing a fuller understanding of the Phase I consent communication process, comprehension of parents and older children, perspectives of clinician- investigators, and motivation for entry into these studies.

描述(由申请人提供)：这项研究的主要目标是了解儿童癌症I期试验中的沟通、理解和决策。该项目将在北美最活跃的6个第一阶段儿科项目中进行，由克利夫兰诊所基金会的生物伦理部进行协调、数据输入和分析。所采用的方法将包括直接观察、数字记录和知情同意会议的编码，以提供关于讨论期间实际发生的情况的有价值的数据，以及父母和年龄较大的孩子的访谈，以确定理解和决策，并通过临床医生问卷获得他们的观点。具体目标是：1)产生和分析定性和定量数据，这些数据将有助于科学理解儿童癌症I期临床试验的知情同意过程。我们将研究第一阶段试验的实际呈现方式，是否以及如何引入临终关怀/姑息治疗等替代方案，以及父母和年龄较大的孩子在沟通过程后理解的内容。我们将发现沟通过程如何影响父母对试验参与的理解和决策，以及临床医生和研究人员的观点如何与父母和年龄较大的孩子的理解不同。2)通过检验影响这两个人群的临床试验沟通、理解和决策的变量，描述I期和III期儿科癌症知情同意之间的异同。我们将通过将沟通、理解和决策的第一阶段结果与我们之前在第三阶段儿童癌症试验中知情同意过程的结果进行比较来实现这一目标。这种比较具有重要的科学意义，因为第一阶段候选儿童的预后非常差，他们的父母在确诊后不再天真或休克。我们预计，这些背景差异将对沟通的性质产生重大影响，将我们的调查结果与第三阶段数据集进行对比，将加强对第一阶段同意的理解。3)组建一个家长知情同意咨询小组(PAGIC)，帮助我们解释我们收集的数据，并根据这些数据为合理设计的干预措施提供建议，以改善儿科癌症I期试验的知情同意。这个10人小组将由参与这项研究的观察/访谈阶段的经验丰富的第一阶段家长组成，并将为我们对结果及其影响的理解提供真实的利益相关者声音。第一阶段临床试验是改善儿童健康努力的关键部分，调查人员有重要责任在知情同意过程中进行有效沟通。这项研究的长期目标将是通过更全面地了解第一阶段同意沟通过程、父母和年龄较大的儿童的理解、临床医生和研究人员的观点以及参与这些研究的动机，来改善对难治性癌症儿童及其家人的护理。