Patients' High Expectations of Benefit in Early Stage Clinical Trials May Not Reflect Poor Understanding
DURHAM, N.C. -- 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
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
"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.