The time period surrounding an initial diagnosis of pediatric leukemia represents a significantly stressful time for most families [1
]. During this time, families are faced with extensive information that they must try to understand and use to make decisions about their child’s care. In addition, most children with pediatric leukemia are offered the option of participating in a clinical trial, which necessitates additional discussions with physicians about clinical trials, known as informed consent conferences (ICCs). Given the additional demands on families’ abilities to understand and assimilate information, it is not surprising that parents often have difficulty with understanding key aspects of informed consent. Indeed, research suggests that many parents have difficulty understanding the multiple fundamental aspects of informed consent, including randomization, the role of choice in participation, and differences between clinical trials and off study treatment [3
These difficulties with understanding basic elements of informed consent highlight the importance of interventions to improve informed consent for pediatric leukemia trials. Research on interventions to improve informed consent have been used with a variety of patient populations, and have included enhancing the readability of consent documents [5
], testing for understanding [7
], and providing additional information through the use of multimedia [8
]. Unfortunately, in a recent review of interventions to improve informed consent across many different populations, Flory and Emanuel [10
] concluded that there are limited data supporting the effectiveness of these interventions, but this review also noted that the use of neutral educators in extended discussions of key aspects of research is a promising area of intervention.
One technique that provides education to families and has demonstrated promise in other areas such as injury prevention, infant sleep, and child rearing practices, is anticipatory guidance [11
]. Anticipatory guidance prior to ICCs may be particularly beneficial for parents of children with pediatric leukemia who are asked to process an abundance of information presented during the ICCs. The guidance might help parents to focus on key elements of doctor-patient communication. Additionally, our research group believed that technology might be useful to supply the anticipatory guidance.
There are major challenges related to providing anticipatory guidance to parents of children very recently diagnosed with leukemia. First, there is the constraint of time and the constant influx of friends/family when a family is receiving this devastating news. Second, pediatric oncology treatment teams are extremely busy when a child is first diagnosed with cancer. One goal of this work was to determine whether it was feasible to integrate this approach into clinical care in a manner that was helpful to families and not disruptive to pediatric oncology treatment teams.
The intervention described in the current paper was created as a result of experience gained during data collection for a clinical trial that examined the efficacy of two interventions in improving parental understanding of informed consent for children diagnosed with pediatric leukemia [12
]. One of these interventions utilized nurse educators in an anticipatory guidance intervention. The second intervention focused on training pediatric oncologists 1) to deliver information in the ICC in a specific order, 2) to encourage parental involvement, via open-ended questions, and 3) to encourage parents to ask questions [12
The content of the anticipatory guidance intervention was aimed at preparing parents for communication with physicians in ICCs and educating parents about the goals of research and treatment; voluntariness of participation; confidentiality; randomization; and other essential aspects of informed consent for clinical trials. Additional details regarding this nurse-delivered intervention have been previously reported [13
]. During recruitment for the nurse-delivered intervention, it was noted that approximately 50% of parents declined participation, which represented a marked contrast to previous experience of recruiting families of children with pediatric leukemia [3
]. Evidence suggested that it was too difficult or overwhelming for some parents to schedule a separate meeting with a nurse educator [13
]. It was decided that the development of a DVD that conveys similar information to what was delivered by the nurses may allow families to access the intervention more readily and would be more cost effective. The goal of the intervention was to improve not only understanding of clinical research but also to encourage and empower parents to be active during discussions with their child’s physicians and to ask questions about areas that were unclear to them.
In this paper, we describe the development, feasibility, and satisfaction with a DVD-based video intervention to improve parental understanding of informed consent and communication with their child’s physicians during ICCs. A secondary goal was to assess the potential effect of the intervention on active parental involvement in ICCs by comparing data from the current study regarding parental question asking during ICCs with data from historical controls.