Children and adolescents with refractory cancer often are invited to participate in early phase clinical drug trials, but making the choice to enroll can be challenging for them and their families. A psychologist at The Children’s Hospital of Philadelphia explored how the extent and quality of communication with physicians, pediatric patients, and their parents may influence this difficult decision.
The study published in the Journal of Pediatric Hematology/Oncology is the first to observe actual informed consent conferences for pediatric phase 1 cancer research. Phase 1 trials are designed to determine the safety of novel agents and evaluate how often a new therapy should be given and at what dosage. During informed consent conferences, physicians provide details about the trial and discuss the patient’s and family’s willingness to participate.
An offer to join a phase 1 study is especially complicated for children with cancer because it typically marks a transition in their disease trajectory when there are no curative options remaining. Although the chance of benefit for phase 1 study participants is usually low, both parents and children frequently hold onto hope for a cure.
In this analysis, Victoria A. Miller, PhD, a CHOP psychologist and assistant professor of anesthesiology and critical care, and co-investigators audiotaped consent conferences for 61 patients ages 7 to 21 who were considering a phase 1 cancer trial. They transcribed and coded the tapes to examine what proportion of the conference was spent between each communication pair, for example physician-to-patient versus patient-to-physician.
The researchers also subcoded the communication by type: giving information, asking and checking, socioemotional, partnership, and social/personal. The majority of communication (73 percent) consisted of physicians “giving information,” which was not surprising, Dr. Miller said, because physicians often focus on full disclosure to meet informed consent regulations.
“When we’re looking at end-of-life decisions and communication with children and adolescents, though, giving all that information might come at the expense of other types of information that might be really important for kids at this time,” Dr. Miller said. “The socioemotional types of communication — things like rapport building, empathy, reassurance, and partnership building — might become lost.”
Another key finding, Dr. Miller said, was that even after controlling for age, patients who had physicians who communicated directly with them perceived that the information was easier to understand. Direct communication can show respect for children and adolescents as developing individuals and also may help them listen to and absorb the information.
“In general, I think it’s important for kids to be directly involved in their own healthcare, regardless of who makes the final decision,” Dr. Miller said. “Even if they don’t have full autonomy yet, there is a way to get their input. At a minimum, we should be asking kids: What do you think? Do you have concerns about what we’ve talked about today or about the different options?”
Particularly with older children and adolescents, the consenting physician should find some time alone with patients to answer any questions. This is potentially important because they might feel freer to share their concerns when their parents are not in the room.
“We know from other research,” Dr. Miller said, “that a frequent goal for parents at this time is to leave no stone unturned in their quest for a cure. And in that context, it might be difficult for kids to express their potential desire to stop disease-directed interventions or to express worries about their treatment choices. Meeting alone with providers could be one way to facilitate their comfort in talking about those things.”
This study, which was supported by the National Institutes of Health, can encourage physicians to use strategies that enhance meaningful patient engagement in all types of clinical trial enrollment, Dr. Miller said.
“It’s less about who makes the decision and more about the process of decision-making and how kids, parents, and providers interact with one another around decisions that need to be made,” Dr. Miller said.
How to best involve children in decisions about their health is a concept that permeates Dr. Miller’s work. She has an ongoing study that is examining children’s involvement in decisions about their enrollment in medical research at CHOP. Parents and children completed questionnaires assessing their perceptions of fairness, voice, and satisfaction with the decision-making process. Dr. Miller’s analysis of the data suggests that children’s involvement in research decisions has potential benefits.