Informed Consent in Pediatric Phase I Cancer Trials

描述（由申请人提供）：本研究的主要目标是了解I期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6个I期儿科项目中进行，并在克利夫兰临床基金会的生物伦理学部门进行协调、数据录入和分析。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，以提供有关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儿童的访谈，以确定理解和决策，以及临床医生的问卷调查，以获得他们的观点。具体目标是：1）生成和分析定性和定量数据，这些数据将为儿童癌症I期临床试验的知情同意过程提供科学理解。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此沟通过程后的理解。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-研究者的观点如何与父母和年龄较大的儿童的理解不同。2)通过检查影响这两个人群中临床试验沟通、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相似性和差异。我们将通过比较I期研究中关于沟通、理解和决策的结果与我们之前在III期儿科癌症试验中关于知情同意过程的研究结果来实现这一目标。这种比较在科学上是重要的，因为I期候选人的儿童预后非常差，他们的父母在诊断后不再天真或休克。我们预计，这些背景差异将对沟通的性质产生重大影响，并将我们的研究结果与第三阶段数据集进行对比，将增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，并根据数据提供合理设计的干预措施的建议，以改善I期儿科癌症试验的知情同意。这10名成员小组将由经验丰富的第一阶段的父母谁参加了本研究的观察/访谈阶段，并将提供一个真实的利益相关者的声音，我们的结果及其影响的理解。I期临床试验是改善儿童健康的重要组成部分，研究者在知情同意过程中负有有效沟通的重要责任。本研究的长期目标是通过更全面地了解I期知情同意沟通过程、父母和年龄较大儿童的理解、临床医生-研究者的观点以及参与这些研究的动机，改善难治性癌症儿童及其家庭的护理。

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.