Children enrolled in clinical trials did not fully understand research

Although a significant number of children with cancer participate in clinical trials, results of a small study indicate that most of these children may not fully understand the research trial.

“Despite recommendations to the contrary, physician-investigators often fail to assess what children understand before they assent to research enrollment,” researchers wrote. “Physicians must establish that children and parents understand their own and each other’s role and responsibilities.”

The researchers conducted face-to-face interviews of 37 children aged 7 to 18 years with cancer. They used a quality-of-assent tool to assess what the children understood about the pediatric oncology research protocols they were enrolled in and their role in the decision-making process.

Data indicated that most children remembered hearing the words “research” or “study,” but 51% said they did not recall hearing that their treatment was considered research.

When asked about their degree of understanding of the explanation of the clinical trial given by their physician, 70% said the information was a “little hard” or “very hard” to understand; 86% said this was because of the language used by the physician during the explanation.

In addition, 73% of the children incorrectly thought that the treatment given during the trial was the best treatment.

All children interviewed said they would like to have a decision-making role in their treatment. However, only 49% recalled being involved in the decision to enroll in a clinical trial, and 38% said they did not feel free to dissent to participation.

Unguru Y. Pediatrics. 2010:doi:10.1542/peds.2008-3429.

Follow the PediatricSuperSite.com on Twitter.