Perspectives of experienced parents about the informed consent process for cancer patient trials

Abstract

Background: Soon after receiving a cancer diagnosis, parents are often asked to consider enrolling their child in a clinical study. It has been shown, however, that this understandably emotional and upsetting time may serve to limit and skew parents' decision-making capabilities and comprehension of the study during the informed consent process. In order for parents to be adequately prepared for what they and their children will experience when deciding to join a study, it is important to understand from parents' perspectives which aspects of the informed consent process are the most meaningful and influential. Objective: This pilot study aims to better understand how well parents' experiences of their child's cancer clinical trial matched the expectations they formed from the informed consent process before enrolling their child in a study. Methods: To gain their perspectives and insights of the informed consent process, 12 parents of children who have recently completed active treatment on a cancer clinical trial participated in a semi-structured interview that asked them to reflect on their decisions and how their experiences in the study compared to the initial expectations they had before joining. Interviews were digitally-recorded, transcribed and coded according to how well experiences matched expectations in four categories: procedures, benefits of treatment, toxicity of treatment and relationships with medical staff. Parents were also asked to complete a Decision Regret Scale and two sociodemographic questionnaires. Results: Most parents reported that being in a study had little to no effect on their experiences, the treatment their child received, and their interactions with medical staff. When asked how their experiences matched their expectations, parents reported the most satisfaction with the accessibility and communication of the medical team, what to expect in terms of benefits of treatment, and the importance of the side effects discussed in the consent form. The most frequently-cited suggestion for improvement was better preparation for follow-up care and planning once child has completed active treatment on the study. Conclusions: The results of the current study show that parents who decide to enroll their child in a cancer clinical trial are better equipped to handle the experiences ahead when they have established realistic expectations of treatment during the informed consent process.