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: 7493445
• 负责人: Eric D. Kodish
• 金额: $ 70.13万
• 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 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7493445
• 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; Hospice Care; 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; Bioethics; Child; Child Care; Child health care; Childhood; Clinic; Clinical Trials; Code; Communication; Comprehension; Consent; Data; Data Set; Decision Making; Diagnosis; Family; Foundations; Goals; Hospice Care; 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I阶段儿童癌症试验中的沟通，理解和决策。该项目将在北美最活跃的I期儿科计划中的6个项目中进行，并在克利夫兰诊所基金会的生物伦理学系进行协调，数据输入和分析。所采用的方法将包括直接观察，数字记录以及知情同意会议的编码，以提供有关讨论中实际发生的事情的宝贵数据，以及父母和年长的儿童访谈，以确定理解和决策，以及临床医生问卷，以获得他们的观点。具体目的是：1）生成和分析定性和定量数据，这将为您对儿童癌症I期临床试验的知情同意过程的科学理解提供信息。我们将研究实际提出I期试验的方式，是否以及如何引入临终关怀/姑息治疗等替代方案，以及在此沟通过程后父母和大孩子的理解。我们将发现沟通过程如何影响父母的理解和决策，以及临床医生评估者的观点如何因对父母和大孩子的理解而有所不同。 2）描述通过检查影响临床试验沟通，理解和决策的变量，描述I期和III期小儿癌之间的相似性和差异。我们将通过比较有关沟通，理解和决策的第一阶段与以前关于III期儿科癌症试验中知情同意过程的发现的发现来实现这一目标。这种比较在科学上很重要，因为是I期候选人的儿童预后较差，父母不再天真或诊断后感到震惊。我们预计，这些上下文差异将对交流的性质产生重大影响，并且将我们的发现与第三阶段数据集进行对比将增强对I期同意的理解。 3）组装一个知情同意书（PAGIC）的父母咨询小组，以帮助我们解释我们收集的数据，并基于数据的数据提供建议，这些干预措施是理性设计的，这些干预措施旨在改善I期儿科癌症试验的知情同意。这10个成员小组将由经验丰富的第一阶段父母组成，他们参加了本研究的观察/访谈阶段，并将为我们对结果及其含义的理解提供真实的利益相关者的声音。第一阶段的临床试验是改善儿童健康努力的关键部分，研究人员在知情同意过程中有效沟通有重要责任。这项研究的长期目标是通过对I期同意交流过程，父母和大孩子的理解，临床医生研究人员的观点以及进入这些研究的动机来提高对难治性癌症及其家人的护理。