The primary goal of this research project is to understand communication, comprehension, and decision-making in Phase I childhood cancer trials. The project will take place at six 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 long-term objective 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, and perspectives of clinician-investigators. The research plan is based on the premise that a rigorous scientific methodology, which this team has previously applied in the Phase III newly diagnosed cancer context, can be adapted to provide accurate and comprehensive information about informed consent in Phase I trials.
- Generate and analyze quantitative and qualitative data that will inform scientific understanding of the process of informed consent for Phase I clinical trials in childhood cancer. Using comprehensive methodology and a solid theoretical framework, 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.
- 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 naïve 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.
- 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.