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.
| Koyfman, Shlomo A; Reddy, Chandana A; Hizlan, Sabahat et al. (2016) Informed consent conversations and documents: A quantitative comparison. Cancer 122:464-9 |
| Johnson, Liza-Marie; Leek, Angela C; Drotar, Dennis et al. (2015) Practical communication guidance to improve phase 1 informed consent conversations and decision-making in pediatric oncology. Cancer 121:2439-48 |
| Hazen, Rebecca A; Zyzanski, Stephen; Baker, Justin N et al. (2015) Communication about the risks and benefits of phase I pediatric oncology trials. Contemp Clin Trials 41:139-45 |
| Miller, Victoria A; Cousino, Melissa; Leek, Angela C et al. (2014) Hope and persuasion by physicians during informed consent. J Clin Oncol 32:3229-35 |
| Miller, Victoria A; Baker, Justin N; Leek, Angela C et al. (2014) Patient involvement in informed consent for pediatric phase I cancer research. J Pediatr Hematol Oncol 36:635-40 |
| Miller, Victoria A; Baker, Justin N; Leek, Angela C et al. (2013) Adolescent perspectives on phase I cancer research. Pediatr Blood Cancer 60:873-8 |
| Crites, Joshua; Kodish, Eric (2013) Unrealistic optimism and the ethics of phase I cancer research. J Med Ethics 39:403-6 |
| Baker, Justin N; Leek, Angela C; Salas, Halle Showalter et al. (2013) Suggestions from adolescents, young adults, and parents for improving informed consent in phase 1 pediatric oncology trials. Cancer 119:4154-61 |
| Cousino, Melissa K; Zyzanski, Stephen J; Yamokoski, Amy D et al. (2012) Communicating and understanding the purpose of pediatric phase I cancer trials. J Clin Oncol 30:4367-72 |
| Marshall, Patricia A; Magtanong, Ruth V; Leek, Angela C et al. (2012) Negotiating decisions during informed consent for pediatric Phase I oncology trials. J Empir Res Hum Res Ethics 7:51-9 |
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