A recent study conducted by Emory University School of Medicine found that therapeutic misconception is alive and well in Phase I cancer research. According to the Chicago Tribune, “people enrolled in early stage trials for possible cancer treatments may underestimate the risks involved and overestimate the potential benefits.”
The culprit: hope. Yes, that’s right. Plain unabashed optimism. As one of the study authors Rebecca Pentz describes it: “When participants describe the risks and benefits of participating in the trial, they may use their descriptions to stay hopeful.” That blasted hopefulness is clouding people’s understanding of research risk and benefit. How horrible!
Seriously, is having hope such a bad thing? So it means that 2/3rds of the participants studied weren’t entirely clear as to the purpose of the study. They equivocated on whether they were a patient vs. participant. They weren’t sure whether their drug regimen was tailored to them or a standard protocol.
So people are confused and misunderstand. But how different is this misunderstanding from the level of comprehension that cancer patients have generally about their care? We know this lack of comprehension in clinical research isn’t unique to cancer, but cancer is, in many ways, special. Cancer care is an increasingly complicated world of complex drug regimens done in repeated cycles of unknown duration combined with pain management and palliative care, psychiatry and other medical services. Knowing why one is doing what one is doing isn’t easy when battling cancer.
Moreover, the study is right to point out that these are people going through a traumatic time in their lives. So perhaps they aren’t as focused on the informed consent form rhetoric because they are fighting for their lives. Go figure.
So is this really a problem? And if so, how might we fix it? Studies like this one are supposed to point us in the right direction. But it seems to leave us only with dismal facts and few answers. Can we change the nature of oncology so that patients understand better, overall, what is happening to them and not just at the very end when they enroll in a Phase I clinical trial? Not easily and not quickly.
As Mary Faith Marshall put it, “It’s understandable that people can be confused, especially if they’re suffering from cancer or in other stressful situations.” This is likely not to be a problem easily fixed by tweaking a few words on an informed consent form.
Summer Johnson McGee