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Parents experience difficulty with consent process in pediatric cancer trials
Date:10/22/2010

he adult patients were offered a trial because they had relapsed or their disease had progressed," he noted.

"For these patients, there wasn't as much urgency in getting started on a protocol, and they had moved beyond the initial crisis of learning that they had cancer."

Conversely, about three-quarters of the pediatric patients were facing a new diagnosis of cancer usually a blood malignancy like leukemia.

"Often they were in the hospital and their parents had known about the diagnosis only for a day or two, and they had to make urgent decisions at a time of tremendous shock and emotional upheaval," Joffe said. "The parents were often overwhelmed and it made them feel less certain they understood the information they were given about the trial."

Joffe said the study confirms concerns that have already prompted efforts to alleviate the confusion surrounding decisions made in the middle of an emotional crisis. For example, some medical personnel now make a return visit to patients or parents "after the initial storm has passed" to make sure they have understood the protocol correctly.

Also, clinical researchers, in some cases, are relieving clinical study recruits of the necessity to make decisions on all aspects of a trial right away, he said. "Often there are randomizations to one treatment or another that occur later in the overall trial, and we are delaying the consent process for those aspects rather than asking people to make all those decisions on Day One."


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Contact: Teresa Herbert
teresa_herbert@dfci.harvard.edu
617-632-4090
Dana-Farber Cancer Institute
Source:Eurekalert

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