Oncologists enrolling children in early-phase clinical trials face hurdles to obtaining informed consent because parents may have unrealistic hopes and are willing to “try anything”, an Australian study shows.
Almost one third of children and adolescents with cancer do not respond to standard therapies and will usually be offered a place in an early-phase clinical trial.
But physicians believe many parents do not understand the limitations of such trials, and this inhibits their capacity to provide full informed consent, according to a survey of members of the Australian and New Zealand Children’s Haematology/Oncology Group (ANZCHOG)
Responses were obtained from 87 healthcare professionals including 33 physicians on their perceptions on obtaining informed consent for early-phase trials.
Parents’ eagerness to “try anything” was perceived as the biggest barrier to obtaining consent, mentioned by 61% of physicians.
Maintaining hope for parents while being honest about the child’s condition ranked the second biggest obstacle, reported by 25% of physicians).
Hope can “provide a coping mechanism for moving forward in an otherwise dire situation,” wrote the study authors from the Kids Cancer Centre at Sydney Children’s Hospital in the Journal of Paediatrics and Child Health.
“It is important for healthcare professionals to carefully balance hope and unrealistic optimism, with the latter being capable of compromising the process of informed consent,” they said.
The survey showed that 62% of healthcare professionals would inform families about early-phase trials without any attempt to influence their decision, while 23% would also suggest the child may benefit.
But it also showed that parents’ misunderstanding of key concepts underpinning clinical trials was an obstacle to informed consent.
While most physicians believed parents understood the voluntary nature of a trial and concepts of toxicity, fewer believed parents understood the benefit of the trial was unknown, but likely to be low.
The survey also revealed significant variations in responses between physicians and other healthcare professionals, suggesting that patients may get “mixed messages” about the benefits and risks of clinical trial participation, they study authors said.
Only 17% of staff received formal training in enrolling a child with cancer in an early-phase trial in a way that allows valid informed consent but almost all said they would be willing to attend an education program.
“Our findings lead us to strongly recommend the development of a formal training programme for healthcare professionals regarding early-phase clinical trial enrolment that focuses on explaining key concepts of trials to families, strategies to facilitate shared decision making and balancing family hopes,” the authors concluded.
“An informational tool to structure the informed consent process and support families in making the decision of whether or not to enrol in an early-phase trial may also be warranted,” they added.