Content area
Abstract
Decisions about participation in clinical research are becoming a common part of treatment seeking for many diseases, yet little is known about how these decisions are made. The purpose of this research was to enhance understanding of parental decision-making regarding their child's participation in a clinical trial for the treatment of acute leukemia by: (1) describing the reasons parents give for enrolling their child in a clinical trial, and (2) examining the factors that influence parental decision-making, including patient, parent, clinician, and social network factors. Informed consent conferences between doctors and the families of 108 children with leukemia were observed and audiotaped. Parent interviews conducted after the informed consent conference were designed to elicit information regarding parents' understanding of the informed consent information as well as factors related to their decision to participate (or not) in a clinical trial for the treatment of their child's leukemia.
In-depth analysis of the informed consent conferences and parent interviews indicates that parental decision-making in this context is quite complex. Although the majority (82%) of parents did decide to participate in the trial, these parents reported many different reasons for their decision. The two most frequently cited reasons for participation in the trial were direct benefit to their child and altruism, but parents also listed the right to withdraw, comparison to standard, safety, the doctor, and better monitoring as reasons. All four factors that were hypothesized to impact decision-making (patient, parent, clinician, and social network factors) were found to shape parental decision-making in some manner.
Two findings in particular have important implications for decision-making and communication research. First, this study provides evidence that the language used by the physician in recommending the trial and presenting the risks and benefits of the trial, including positive/negative and specific/general framing of issues, impacted parental decision-making in many ways. Second, parental decision-making was affected by the significant roles played by social network members both during and after the informed consent conferences. Physician sensitivity to the influence that they and social network members have on parental decision-making can improve doctor-family interactions and aid parents in making this difficult decision.
