Informed consent: Helping parents of kids with leukemia

Program encourages families to ask questions

In the days after a child has been diagnosed with leukemia, parents often must wrestle with decisions about participation in clinical trials. It's a busy and stressful period, as family members are still dealing with the trauma of the diagnosis.

To try to help families through this difficult time, researchers must not only get information to them in an understandable way, but without inconveniencing them as they deal with demands of their child's clinical care.

Rebecca Hazen, PhD, a psychologist at Rainbow Babies and Children's Hospital in Cleveland, OH, says she noticed while working on studies that it was difficult to schedule with families to relay information to them.

"Sometimes it was hard to get parents to agree to sit down for an extra session with a nurse to go through this information," she says. "In some studies we had done, we had a pretty high participation rate, but we were finding there were a fair amount of people who said they just didn't have time for this."

So when her team developed an anticipatory guidance to help lead families through the informed consent process, they instead used a DVD presentation, which made it available for the family to review on their own time.

The guidance is not for a particular study, but seeks to explain to families what they should expect from informed consent in general. Hazen says the goal was not necessarily to increase participation — she says most children with leukemia end up participating in clinical trials — but to better prepare the parents for dealing with the informed consent process, and in turn improve understanding.

"We're really more interested in improving the process," she says. "It's more about making sure that they actually understand what they're agreeing to participate in."

Encouraging questions

Anticipatory guidance is a technique that also has been used in injury prevention and relaying child-rearing information to families. In this study, it consisted of a 20-minute video that educated parents about the goals of research and treatment, the principle of voluntary participation, confidentiality protections, the idea of randomization and other aspects of informed consent for a clinical trial.

"One of the big goals of this was to help them going in (to the informed consent) to be more active participants during the discussions," she says. "If we prepare them for what's going to happen, it's going to be easier for them to ask questions, to engage in more of a dialogue versus going in and not knowing what to expect ahead of time."

Throughout the video, Hazen says, parents are encouraged to take notes and ask questions. The DVD actually instructs parents to pause the video at various points and write down any questions they have.

"If parents are more engaged and they ask more questions, it leads to better understanding," she says. "So there was a big emphasis in the video on the fact that the physician wants you to ask questions. We wanted to really hammer home that point with them that we want you to be involved in the conversation."

The video features oncology physicians and nurses speaking directly to the camera about the consent process. In the video, parents are told that they can have the consent carried out in the place that is most convenient for them and to decide whom they would like to be present.

They're encouraged to ask for breaks, if needed, during the informed consent, or to ask the doctor to slow down or explain unfamiliar words. "If the doctor moves on to a topic before you are ready, you may want to stop and ask, 'Could you please go back to what you were talking about and tell me a little more?'" a nurse advises in the video.

Testing with parents

Hazen's team tested the DVD intervention with a dozen parents at Children's Hospital of Pittsburgh whose children had been recently diagnosed with leukemia. After obtaining informed consent, participants watched the video on a portable DVD player in the child's room with a research assistant. Parents were given paper and pencils to write down questions. While the research assistants did not answer questions themselves, they referred parents to the informed consent conference.

At those later conferences, parents' questions were counted and compared to previous studies looking at communication during informed consent conferences.

The parents who viewed the video had a higher rate of questions during conferences than parents in previous studies. Most parents said the video made it easier for them to understand what the physician was telling them, to think of questions to ask and to feel more comfortable with asking questions.

Parents said they appreciated the brevity of the video, and a few reported watching it additional times with other family members.

The study turned up one unusual finding. While nine of the parents reported that watching the video either decreased their anxiety or had no effect on anxiety, three parents reported that their anxiety increased after watching it (two of them by "a little" and one by "a lot").

Hazen suspects that some people are temporarily made more anxious when they get more information. Hazen's group theorizes that that anxiety would have occurred later anyway, when the information was presented during the informed consent conference.

Hazen says she'd like to try the intervention with a larger sample to get more data on this and other issues.

The video is available online to members of the Children's Oncology Group or others who might be interested in using it at:


  1. Hazen, RA, Eder M, Drotar D, et al. A feasibility trial of a video intervention to improve informed consent for parents of children with leukemia. Pediatr Blood Cancer 2010; Jan 8:(Epub).