Compared to adult patients, parents felt less informed about protocols
Steven Joffe, MD, MPH
Compared with adult cancer patients, parents of children with cancer
were more likely to be dissatisfied with the informed consent process
for participating in clinical trials, according to a study from
Dana-Farber/Children's Hospital Cancer Center.
The findings will be presented at the 42nd Congress of the
International Society of Paediatric Oncology (SIOP) in Boston on
Saturday, Oct. 23.
Parents who had agreed to their children's enrollment in treatment
trials said they felt hurried in making the decision, the researchers
They also perceived themselves as less well-informed about the
clinical trial protocols than did adult patients, even though tests
showed they understood the issues equally well.
"These findings were consistent with what we suspected, given the
different contexts in which adult and pediatric clinical trials are
offered," said Steven Joffe, MD, MPH, senior author of the study. "But I didn't expect such large differences."
The researchers administered questionnaires to 47 parents and 204
trial participants within two weeks after the clinical study began.
Results showed that only 64 percent of parents felt they had enough
time to learn about the trial, compared to 87 percent of adults. The
parents were also less likely (79 percent to 93 percent) to report that
they had sufficient opportunity to ask questions.
Even though they scored about the same on objective tests about the
trials' particulars, parents of children with cancer rated themselves as
less knowledgeable (79.5 percent) than did adult patients (87.8
Joffe, an ethicist and pediatric hematologist/oncologist at
Dana-Farber/Children's Hospital Cancer Center, attributed much of the
disparity to the differing contexts in which adults and pediatric
patients are offered clinical trial participation.
"The adult patients tended to have solid tumors and had lived with
their disease for a long time. Most of the adult patients were offered a
trial because they had relapsed or their disease had progressed," he
"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
"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
"The parents were often overwhelmed and it made them feel less
certain they understood the information they were given about the
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."
The abstract is being presented at SIOP by first author Tony Truong,
MD, of the Hospital for Sick Children in Toronto. Other authors are E.
Francis Cook, ScD, of the Harvard School of Public Health and Jane
Weeks, MD, of Dana-Farber.