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Multicenter Study
. 2012 Dec 10;30(35):4367-72.
doi: 10.1200/JCO.2012.42.3004. Epub 2012 Oct 15.

Communicating and understanding the purpose of pediatric phase I cancer trials

Melissa K Cousino  1 , Stephen J Zyzanski, Amy D Yamokoski, Rebecca A Hazen, Justin N Baker, Robert B Noll, Susan R Rheingold, J Russell Geyer, Stewart C Alexander, Dennis Drotar, Eric D Kodish
Affiliations
Multicenter Study

Communicating and understanding the purpose of pediatric phase I cancer trials

Melissa K Cousino et al. J Clin Oncol. .

Abstract

Purpose: Quality informed consent should provide a clear understanding of the purpose of the research. Given the ethical challenges of pediatric phase I cancer trials, it is important to investigate physician-parent communication during informed consent conferences (ICCs) and parental understanding of the purpose of these studies.

Methods: In the multisite Informed Consent in Pediatric Phase I Cancer Trials study, 85 ICCs for phase I research between June 2008 and May 2011 were directly observed, and 60 parents were subsequently interviewed. The scientific purpose was defined as composite understanding of drug safety, dose finding, and dose escalation. We determined the frequency with which physicians explained these and other phase I-related concepts during the ICC. Parent interviews were analyzed to determine understanding.

Results: The child was present at 83 of 85 ICCs. Only 32% of parents demonstrated substantial understanding of the scientific purpose of phase I cancer trials; 35% demonstrated little or no understanding. Parents of higher socioeconomic status and racial majority status were more likely to understand the scientific purpose. Factors associated with understanding included physician explanation of the goal of the applicable phase I protocol offered (explained in 85% of ICCs) and explanation of the dose cohorts (explained in 43% of ICCs). Physicians explained drug safety in 23% of ICCs, dose finding in 52% of ICCs, and dose escalation in 53% of ICCs.

Conclusion: Many parents of children participating in phase I trials do not understand the purpose of these trials. Physician-parent communication about the purpose of phase I research is lacking during ICCs.

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Conflict of interest statement

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
Communication and understanding of scientific purpose. A comparison of physician explanation with parental composite understanding scores in 60 cases is shown. Explanation and understanding scores range from none (0.0) to complete (3.0). The blue shaded area indicates cases in which physician explanation equaled or exceeded parental understanding. ICC, informed consent conference.
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