stabilized. These mothers were able to clearly differentiate between their child’s usual care and the research activities. Their families had had time to adjust, to some extent, to the diagnosis and did not confront the need for crisis-driven decision making about the participation of the child in research. They also had had time to develop some expertise in negotiating and working within the health care system.
Kodish and colleagues (1998) reported that pediatric cancer researchers believed that parents’ “state of shock” was the major factor interfering with understanding of the participation decision (see also, Simon et al., 2001). These findings are consistent with those of other studies about parents’ decision making about clinical care in the face of a child’s cancer diagnosis. These studies point to a high state of parental anxiety and the frequent sense of not having a real choice (Ruccione et al., 1991; Hinds et al., 1996; Levi et al., 2000). Levi and colleagues (2000) reported that these stressed parents “did not verbalize distinctions between their understanding of their child’s medical treatment, [and] research participation” (p. 3).
Deatrick and colleagues (2002) undertook a retrospective analysis of transcripts of interviews and other information related to an earlier study of decision making by parents (n = 21) of children with advanced cancer about the child’s participation in phase 1 trials. All the families were facing situations in which all other treatments with curative intent had failed. More than half the parents (n = 13) reported that they had no choice; as one said, “you have to try everything … keep fighting to keep her here with me” (p. 118). As described by the researchers, the parents’ expectations included “providing treatment, buying time for another therapy, working a miracle, being altruistic, and delaying death” (p. 117). Some parents were clear that they were hoping for a miracle. At least one parent spoke of the doctor’s optimism about the drug as the deciding factor.
Using a combination of interviews and focus groups, Caldwell and colleagues (2003) studied 33 Australian parents whose children’s health status ranged from healthy to seriously ill. The investigators reported that parents of ill children, some of whom were or had been involved in clinical trials, saw the greatest potential for direct or personal benefit from the trial. Not surprisingly, these parents were also more knowledgeable about trials. As viewed by one parent whose child had participated in a trial, children not participating were “missing out,” whereas participating children were “getting the benefit” (p. 556). Parents of ill children were concerned about “blinded” studies that withheld information about the treatment that their child was receiving. Parents of children with cancer mentioned that they wanted to monitor medications because of past experience with medical errors. (The majority of parents approached by Caldwell and colleagues either declined outright to participate in the interviews or did not participate after indicating that they would.)