Clinical Trials in Pediatric Cancer: Parental Perspectives on Informed Consent

Abstract

To better understand parental perceptions of the informed consent process in pediatric oncology clinical trials, 20 parents of newly diagnosed children at two pediatric cancer centers described their perceptions in a semi-structured interview. They recalled well the diagnosis, the general treatment plan, and the statistics of survival and/or cure, but the research nature of the clinical trials, particularly randomization, was not well understood. However, despite the need to assimilate a great deal of information, time pressure to make decisions, and reportedly high levels of distress during the discussions, parents expressed general satisfaction with the informed consent discussions with their pediatric oncology providers. However, half to two thirds of parents felt there had been inadequate discussion of alternatives to the proposed treatment and of the research nature of the protocol. While further study of the informed consent process should be conducted in larger, representative samples, the findings from this pilot study suggest that a goal of future informed consent interventions should be to improve parents' understanding of the research aspects of treatment. It is critical to parents' ability to provide informed consent that they feel satisfied that they know alternatives to proposed treatment and that they understand the randomization of treatments, which is the gold standard of clinical trials in pediatric oncology.

Determinants of decision-making and patient participation in paediatric clinical trials: A literature review

“…The randomization process should be explained more explicitly: Parents need to be clearly informed that random assignment is one of the procedures that differentiates participating in the randomized clinical trial (and other trial designs) from standard treatment [18, 35,[44][45][46]. Therefore it is necessary to indicate to parents when the clinician is discussing trial-related issues and when they are discussing standard treatment issues [35].…”

“…Even after signing the consent form, parents frequently seem to misunderstand the concept of randomisation [42][43][44]. The randomization process should be explained more clearly: Parents need to be clearly informed that random assignment is one of the procedures that differentiates participating in the RCT from standard treatment [18,35,[44][45][46].…”

“…The randomization process should be explained more clearly: Parents need to be clearly informed that random assignment is one of the procedures that differentiates participating in the RCT from standard treatment [18,35,[44][45][46]. The lack of understanding of randomization may result in a parent's disappointment [32,43] that their child was assigned to the control group.…”

“…After some time, many parents may even forget that they have been approached for consent and that their child participated in a clinical trial [44,50].…”

Factors Related to Voluntary Parental Decision-Making in Pediatric Oncology

“…In prior qualitative research parents of children with cancer reported feelings of shock and distress that impaired their decision-making about treatment 8 and research participation. 9,10 Parents reported feeling pressured to agree with physicians regarding treatment 8 and perceived few alternatives with respect to treatment 11,12 or clinical trial enrollment. 9 A number of demographic and contextual factors may relate to voluntariness, including demographic characteristics such as gender, 13 race, 14 education, 15 and income; 2,16 previous experience with a similar decision; time since diagnosis; parents' concern that the child' s care could be negatively affected or the medical team would be upset if the parent declines; 4,17 others'attempts to coerce, pressure, or manipulate the decision; 18 time pressure; 8,13,19 and the amount of information provided (too much or too little).…”