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Communicating and understanding the purpose of pediatric phase I cancer trials

Melissa K Cousino1, Stephen J Zyzanski, Amy D Yamokoski

  • 1Case Western Reserve University, Cleveland, OH, USA.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
|October 17, 2012
PubMed

Insights

Many parents lack understanding of pediatric phase I cancer trial purposes. Physician communication during informed consent conferences (ICCs) needs improvement to ensure parents grasp study goals like dose escalation.

Area of Science:

  • Pediatric Oncology
  • Clinical Trial Ethics
  • Informed Consent

Background:

  • Informed consent is crucial for ethical research, especially in pediatric phase I cancer trials.
  • Understanding the purpose of these trials is vital for parental decision-making.
  • Physician-parent communication during informed consent conferences (ICCs) is key.

Purpose of the Study:

  • To investigate physician-parent communication during ICCs for pediatric phase I cancer trials.
  • To assess parental understanding of the scientific purpose of these complex studies.

Main Methods:

  • Direct observation of 85 informed consent conferences (ICCs) for phase I pediatric cancer trials.
  • Interviewing 60 parents post-conference to evaluate their understanding of the trial's scientific purpose.
  • Defining scientific purpose as understanding drug safety, dose finding, and dose escalation.

Main Results:

  • Only 32% of parents showed substantial understanding of the scientific purpose; 35% had little or no understanding.
  • Higher socioeconomic and racial majority status correlated with better understanding.
  • Physician explanation of the protocol goal (85%) and dose cohorts (43%) were associated with parental understanding.

Conclusions:

  • A significant gap exists in parental comprehension of pediatric phase I cancer trial objectives.
  • Current physician-parent communication during ICCs is insufficient to convey the research purpose effectively.
Abstract

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