Study patients often misunderstand trial goals

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Study patients often misunderstand trial goals

By Charnicia E. Huggins

NEW YORK, Nov 28 (Reuters Health) - Many patients who agree to

participate in clinical trials do not completely understand how such

studies work. What's more, their doctor may be misinformed as well,

according to a new report.

The study included more than 200 cancer patients who recently enrolled

in a clinical trial, and 240 of the providers who obtained the patients'

" informed consent. "

The investigators found that 25% of the patients, and more than half of

the providers, were not aware that cancer clinical trials are intended

to improve the treatment of future cancer patients--not necessarily the

patients being studied.

Further, nearly half of the patients thought that the treatments and

procedures performed in the trial were standard for their type of

cancer, and almost 30% thought that the treatment being researched had

already been proven to be the best treatment for their cancer.

Still others were not aware of the additional risks or discomforts that

may be associated with the treatment being researched or that they may

not receive any direct medical benefit from their participation in the

clinical trial.

" Many cancer patients who participate in clinical trials of new

therapies misunderstand important aspects of their trials, " lead study

author Dr. Joffe, of the Dana-Farber Cancer Institute in Boston,

Massachusetts, told Reuters Health. " Surprisingly, we also found that

many cancer treatment professionals shared some of (the same)

misconceptions. "

Most of the study participants had experienced a cancer relapse and had

a 1 in 10 chance, or less, of surviving disease-free for 5 years,

according to their doctors.

Nearly half of the patients reported participating in consent

discussions that lasted for at least one hour, and fewer than one-third

signed the consent form at the first meeting, according to the report in

the November 24th issue of The Lancet.

The majority (92%) of patients agreed or strongly agreed that their

questions during the discussion were answered thoroughly and 90% said

they were satisfied with the informed consent process.

What's more, 75% of the patients said their decision to participate was

easy or very easy and 90% agreed or strongly agreed that the treatment

needed to begin as soon as possible, the report indicates.

" When cancer patients and professionals consider the possibility of

participating in a clinical trial, they generally discuss the risks and

benefits of, as well as the alternatives to, participation, " Joffe said.

" Our study suggests that it is also important to discuss with patients

the ways in which participating in a clinical trial is different from

receiving ordinary medical care. "

Patients that tended to have a better understanding of the process were

those who had a college education, used only English at home, used a

National Cancer Institute consent form, did not sign the consent form at

the first meeting, had a nurse present during the consent discussion,

and said they read the consent form carefully, the researchers note.

" Cancer patients who participate in clinical trials generally receive

treatment that is at least as good as they would receive outside of the

trial, " Joffe explained. " Nevertheless, it is important to realize that

trials are designed mainly to improve treatment for the future.

" Continued trial participation is essential because without it, we will

be unable to make progress for the next generation of cancer patients, "

he added.

SOURCE: The Lancet 2001;358:1772-1777.