The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent

Abstract

BACKGROUND: Most children with cancer enroll in clinical research trials. Whenever possible, children must provide their assent before enrolling in research studies. We studied what children aged 7 to 18 with cancer understand about research, their research-related treatment, and their preferences for inclusion in decision-making. PROCEDURE: Thirty-seven face-to-face, audiorecorded interviews using a novel, semi-structured tool, the quality-of-assent instrument, were conducted. Exploratory univariate and bivariate analyses of the quantitative data elucidated patterns and trends of understanding and preferences. RESULTS: Nineteen of the 37 children (51%) did not know or recall that their treatment was considered research, and 19 of 22 (86%) did not understand their doctor when he or she discussed the trial. More children enrolled in trials to help future children with cancer (27 of 37 [73%]), than to get better personally (22 of 37 [60%]). Irrespective of age, children with Hodgkin's disease, germ-cell tumors, and leukemia had significantly greater research awareness and appreciation than children with other cancers (P = .019 and P < .001, respectively). Although all children wanted to be involved in decision-making, 18 of 37 (49%) did not have or recall having a role in deciding to enroll in their trial, and 14 of 37 (38%) did not feel free to dissent to trial enrollment. Only 4 of 37 children (11%) discussed increased decision-making roles with parents, and only 7 of 37 (19%) discussed them with their doctors. CONCLUSIONS: Most children have limited understanding of research despite physicians' explanations. Many children reported that they feel minimally involved in the decision to enroll in clinical trials. Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful.

Why do children decide not to participate in clinical research: a quantitative and qualitative study

“…This therapeutic misconception was prevalent in the population of children younger than 13 y, but not in late adolescents. In adults, therapeutic misconception emerged as a major theme (16); in previous studies in children, it was prevalent as well (13). Thus, in children, understanding of the purpose of clinical research relies heavily on the provision of information, which should be tailored to their comprehension level (17).…”

“…Providing participants with inadequate information concerning the particulars of the research also interferes with the participants' ability to make well-considered decisions (10). Studies in adolescents, one of which concerned a hypothetical research project, demonstrated that several participants expected direct health benefit from being questioned and examined by the physician (11)(12)(13). A main reason for participation was charity (14), and half of the eligible subjects refused for no apparent reason (15).…”

Psychosocial Barriers and Facilitators to Clinical Trial Enrollment and Adherence for Adolescents With Cancer

“…29 Research examining knowledge about clinical trials among children and adolescents has delineated a lack of understanding of what clinical trials are, the difference between clinical versus nonclinical research treatments, and incorrect assumptions about the level of invasiveness of clinical trial interventions compared with standard treatments. 30,31 Misinformation and a lack of awareness may also be the result of poor readability, understandability, and clarity of consent forms used in child and adolescent cancer research and clinical trials. 32,33 A medical provider' s knowledge of available clinical trials and communication about clinical trial information can also affect an adolescent' s awareness level.…”

“…30 The importance of speaking directly to the child or adolescent, instead of solely to the parent, was also reported. Children and adolescents aged 7 to 18 years in the same study also reported that speaking to other children and adolescents who are already enrolled in clinical trials would be helpful during the decision-making and consenting process.…”

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

“…It should be noted however that, in comparison to adults, children's understanding of their specific health conditions, of the global concept of illness and of medical research is more basic and improves with maturation [18,23]. Specifically, the concept of treatment alternatives, the duration of participation, the right to withdraw and the voluntary nature of participation seem to be difficult to understand [23,24] even if the potential participants were adolescents [25].…”