Cancer Quarterly Communication Breakdown

Randomization In Clinical Trials Baffles Many Parents Of Children With Leukemia

Of all the decisions parents must make for their children, few could be more challenging than the decision to enroll a child with cancer in a clinical trial. Worse yet, a study published in the Journal of the American Medical Association suggests many parents are making this choice without a full understanding of how their child will get treatment.

Randomized clinical trials have been credited with dramatically improving treatment of the most common childhood cancer, leukemia. In these trials, patients are usually given one of two or three different treatments. But doctors do not choose which patient gets which treatment; rather, the participants are assigned to treatments at random, either by a computer or by some other unbiased method. Each participant has as much chance of being assigned to receive standard treatment as the new therapy being tested.

Researchers from Rainbow Babies and Children’s Hospital in Cleveland, Ohio, found that many parents of children with leukemia didn’t understand this concept, called randomization, even though doctors explained it to them. That means many parents aren’t truly giving informed consent when they allow their children to participate in such research.

Although children with cancer are likely to receive excellent treatment regardless of whether they enter a clinical trial or not, said lead researcher Dr. Eric Kodish, it’s nonetheless important for parents to fully understand what they’re signing their child up for, and why they’re doing it.

“We think that clinical trials are good and that communication needs to get better,” he said. “The key benefit is the knowledge that’s generated for future children with leukemia.”

Not Getting the Message

Kodish and his colleagues tape-recorded the informed-consent discussions doctors had with parents of children newly diagnosed with leukemia. In these conferences, the doctors explained the diagnosis to the parents and gave them information about appropriate clinical trials. Shortly after, the researchers interviewed 137 of the parents to determine whether they understood randomization.

Half of the parents did not understand the concept, and those of racial minority or low socioeconomic status were least likely to understand. Yet doctors explained randomization in 83{06cf2b9696b159f874511d23dbc893eb1ac83014175ed30550cfff22781411e5} of the conferences, and the explanations did not differ appreciably between groups of parents. Eighty-four percent of the children were enrolled in a clinical trial.

Those results point to a need for better strategies to explain the clinical trials process, said Kodish, who is director of the Rainbow Center for Pediatric Ethics. “It’s not that doctors aren’t trying,” he pointed out. “It’s that the message isn’t getting through.”

Kodish and his team worked with an advisory group of parents who have been through the decision-making process about clinical trials to come up with ways to help parents make informed decisions for their children.

Among their suggestions was encouraging parents to ask questions — and doctors to continue explaining — until they feel the parents understand. Cultural sensitivity training for doctors could also help improve communication with minority parents, the team suggested.

But one of the most important aspects is providing emotional support for parents.

“It’s an extraordinarily stressful time for parents to be involved in an informed-consent process, right after being told their child has leukemia,” Kodish said. “They’re essentially bereaved, they’re grieving, and there’s a sense of loss of control.”

Providing adequate emotional support can help put parents back on an even keel so they can learn about the clinical trial and decide whether to participate.

“Having a child diagnosed with leukemia is such a compelling and overwhelming situation that parents just want to sign something to allow treatment to begin,” Kodish said. “It”s important for parents to understand what leukemia is and what the best current treatment is before they can understand a clinical trial.”

This article was obtained from the American Cancer Society.