An optimistic outlook is often believed to have a positive impact on cancer. But researchers now say that optimism, like anything else, can be overdone. And “unrealistic optimism,” which a new study has found to be common among patients enrolling in early phase drug trials, may have a serious downside.
The problem, some experts say, is that unrealistic optimism may lead patients to sign up for very early stage trials when the patients might make other choices if they really understood and completely absorbed the true risks and benefits.
To learn more about the attitudes of patients in early phase trials, which only test toxicity of drugs and aren't intended to have a therapeutic benefit, researchers surveyed 72 patients with advanced cancer. All had signed up for phase I or phase II drug trials, according to a report published in the January issue of the journal IRB: Ethics & Human Research.
The patients were asked several questions to determine whether they thought they were more likely to benefit from the new, unproven therapy than other people in the trial.
Almost 60 percent said they believed they would, even though "patients are given an informed consent form that states that the trial is not intended to offer a direct therapeutic benefit,” said Lynn A. Jansen, lead author of the new study and professor at the Center for Ethics in Health Care at the Oregon Health and Science University.
Still, it’s not surprising that patients hold out hope. People who participate in phase I trials have already tried every available medical intervention for their cancers, Jansen explained. So the only options open to them at this point are to participate in research studies or to seek hospice care.
Ultimately, the new findings create an ethical dilemma for researchers signing patients up for these early stage trials, Jansen said. It means that patients aren’t really giving informed consent, she explained. Even though a patient may parrot back the list of risks and benefits that have been explained to them, they may still have unrealistic expectations that the therapy is likely to help them.
Jansen compares this kind of thinking to what smokers sometimes do. Though they read the risks listed on warning labels, some smokers believe that because of some factor — such as being young, exercising or eating healthy — the risks of lung cancer are lower for them. Newer anti-smoking ads try to make people see that the risks apply as much to them as anyone else.
In the new study, Jansen asked people to say whether they thought they would be more likely than other patients in the study to have their cancer controlled by the drug being tested. After finding that many did, the researchers followed up with individual interviews to try to understand why. “They often thought there was something they could do to control the outcome, such as make sure they followed all the researchers’ advice or be sure to come to all their appointments,” Jansen said.
Cancer specialists weren’t surprised to hear that patients were overly optimistic. And some weren’t convinced that that was a bad thing.
“If you want to think you are going to be the one in 50 or one in 100 people who gets helped by a therapy, I’m not going to take that away from you,” said Dr. Adam Brufsky, associate director for clinical investigation at the University of Pittsburgh’s Cancer Institute.
“By the time patients are signing up for Phase I trials, their only other option is palliative care. Some people choose that. They say they want to spend whatever time they have left doing what they want and not coming in for treatments and tests. But others say they want to go down fighting.”
Concerns about quality of life
For Dr. Thomas Strouse, the real concern is that unrealistically optimistic patients might ignore or decide not to report side effects fearing they’ll be dropped from the trial. This might lead to patients getting less pain management, said Strouse, a professor of clinical psychiatry at the University of California, Los Angeles. It could also result in skewed side effect results.
The other fear is that patients won’t opt for hospice care — and a better quality of life in their final months or weeks — because they haven’t admitted to themselves that they won’t get better, said Dr. Lynn Schuchter, chief of hematology/oncology at the Abramson Cancer Center at the University of Pennsylvania.
Ultimately, the effect that Jansen and her colleagues observed isn’t limited to cancer patients who take part in early phase clinical trials, Schuchter said.
“This occurs throughout the continuum in advanced cancer,” she explained. “Even when you explain that the response rate to a particular therapy might be 15 percent, you’ll see patients interpret those statistics with the same type of bias. Many will take the treatment even if the benefit is really low. They don’t really hear the negatives. And they latch on to whatever positives one says about a treatment.”
Still, Schuchter said she was impressed at how well the patients in the new study actually understood the benefits and risks described to them. “They got the message,” she said. “But at the end of the day, they were hopeful that they would be the patient who benefited from it.”