Enrolment in paediatric oncology early‐phase clinical trials: The health‐care professionals' perspective

Abstract

Aim Approximately 20–30% of children/adolescents with cancer will not respond to standard therapies. These children are usually offered experimental treatment in the form of an early‐phase clinical trial. We examined the perspectives of health‐care professionals (HCPs) regarding obtaining informed consent for early‐phase trials in paediatric oncology. Methods We collected survey data from 87 HCPs working in paediatric cancer centres across Australia and New Zealand. Results HCPs were, on average, 44 years old (range = 25–74), with 15.8 years' experience in paediatric oncology (range = 1–40). Few HCPs (17.4%) received training for early‐phase trial consent; however, most were willing to attend training (77.9%). HCPs (61.6%) reported that they informed families about early‐phase trials without any attempt to influence their decision. However, 23.3% of HCPs reported that they informed families that their child would benefit. HCPs' main obstacle in obtaining consent was their perception of parents' eagerness to ‘try anything’ (52.3%). HCPs perceived that many parents misunderstood key clinical trials concepts, with 25.2% of HCPs believing that not being given clear information influenced parents' decisions. Physicians were more likely than social workers/nurses to inform families that other children will benefit from enrolment in the study. Social workers/nurses appeared to rate the chance of benefits for the patient higher than physicians. Conclusions HCPs may experience difficulty conducting early‐phase trial consultations and obtaining valid informed consent. Our study highlights the need for formal training for HCPs and additional patient education tools.

Stakeholder perspectives on clinical research related to therapies for rare diseases: therapeutic misconception and the value of research

“…For example, Hendersen et al demonstrated in their study of early phase gene therapy that while some participants may understand they are in a research study to generate generalizable knowledge, they may still have unrealistic expectations about the direct benefit of the therapy under study [38]. A recent survey of health care professionals working in pediatric cancer centres also demonstrated similar results to ours in that the majority of health care professionals surveyed believed perception of medical benefit for the child was a primary motivating factor for parents' consent for participation in earlyphase clinical trials [40]. Therapeutic misconception is a complex concept that warrants further investigation in the field of rare diseases.…”

“Balancing Expectations with Actual Realities”: Conversations with Clinicians and Scientists in the First Year of a High-Risk Childhood Cancer Precision Medicine Trial

“…Clinicians face the additional challenging task of managing informed consent consultations and addressing family expectations in a setting that often sits at the junction between research and clinical practice [15,16]. Not surprisingly, there is evidence that patients and their parents may misunderstand the aims of early phase oncology research [17] including the implications of genomic tumour profiling [18,19].…”

Multilevel barriers and facilitators of communication in pediatric oncology: A systematic review

“…For families, the following characteristics and behaviors were identified as potential barriers or facilitators of communication: parental preferences for disclosure, 57,61,67,74,82–87 family's expectations regarding disease course, 10,54,61,88–91 family's emotional state, 40,42,92–96 preparedness to receive difficult news, 39,41,61 comfort with the topic, 52,69,97–99 demonstrated priority/importance of the topic, 36,51,52,66 level of medical knowledge or education, 35,41,43,57,61,63,91,92,100,101 internal family functioning, 54,102,103 age of the child, 51,63,72,104–106 parental fears of harm to the child from communication, 41,92 and lack of fluency in the majority language 99,107–110 …”