Patients' High Expectations Of Benefit In Early Stage Clinical Trials May Not Reflect Poor Understanding
Patients who express high hopes that a clinical trial can help them aren't ignoring the risks, they just believe that a positive attitude might improve their chances.
Bioethicists and clinicians have been concerned that patients being asked to submit to experimental treatments for cancer have unrealistic expectations of benefits from what could be a risky therapy with significant side effects. But a new study led by Duke University Medical Center researchers has found that they understand the risks and side effects just fine.
"Our study suggests that you cannot always interpret patients' high expectations of benefit as clear signs of poor understanding," said Kevin Weinfurt, Ph.D., a medical research psychologist at the Duke Clinical Research Institute and lead investigator of a study presented Saturday, June 2, at the American Society of Clinical Oncology annual meeting in Chicago. The study was funded by the National Cancer Institute.
Researchers asked study participants, all of whom were enrolled in Phase I or Phase II oncology trials, a series of questions relating to their expectations of benefit. The questions were divided into three types: "belief-type," which assessed confidence that the treatment would work for them; "frequency-type," which asked participants to estimate how many patients on a trial might derive benefit; and "vague," which asked participants to answer questions such as, "What is the chance that this experimental therapy will control cancer."
Participants tended to provide higher expectations in response to the belief-type questions than in response to the other two question types, Weinfurt said. The researchers also found that only 16 percent of participants said their answers to the questions were based on information they received from their clinicians or from the informed consent process.
"The most common justification that participants gave for their answers involved the opinion that expressing a positive attitude would enhance their chances of being helped by the therapy," Weinfurt said.
Researchers concluded that participants expressed different expectations of benefit depending on how the questions were asked and that participants focused more on expressing hope than truly demonstrating an understanding of the risks and benefits of the clinical trial.
"Our study uncovered some of the factors that motivate people in these clinical trials, and in so doing, leads us one step further to refining the methods by which we obtain and evaluate informed consent," Weinfurt said. "These patients are undergoing a lot to participate in these trials and it is our responsibility as investigators to be certain that they completely understand the risks and benefits."
Other researchers involved in this study were Damon Seils, Janice Tzeng, Kate Compton and Kevin Schulman of Duke; Daniel Sulmasy of St. Vincent's Manhattan and the New York Medical College; Alan Astrow of Maimonides Cancer Center; and Neal Meropol of the Fox Chase Cancer Center.