PARTICIPANTS, INVESTIGATORS OFTEN HAVE MISCONCEPTIONS ABOUT CANCER TRIALS

While most cancer trial participants are satisfied with the informed consent process, most do not have a clear understanding of the trial’s purpose or the treatment involved, according to a report in the November 24, 2001 issue of The Lancet.

Even physicians involved in these trials often have misconceptions. Dr. Jane C. Weeks, from the Dana Farber Cancer Institute in Boston, and colleagues surveyed 287 cancer patients who had just enrolled in a clinical trial, to ascertain their understanding of the trial. 91 providers who had obtained consdent for a trial were also surveyed. 90% of patients were satisfied with the informed consent process. In addition, most patients considered themselves to be well-informed about the trial. Despite this, most patients did not recognize the trial treatment as non-standard (74%), the risk that participation conferred (63%), or that the treatment was unproven (70%). 29% of patients did not realize that the treatment benefits were uncertain, and 25% were unaware that themain purpose of the trial was to benefit future patients.

Increased trial knowledge was linked to having a college education and speaking only English at home. In addition, knowledge was increased when the U.S. National Cancer Institute consent form template was used, the form was read carefully and not signed at the initial discussion, and when a nurse was present. Less than half of providers understood that the main reason for clinical trials is to benefit future patients. "As physicians, we need to be clear, in our own heads about the real goal of clinical trials and be sure we communicate that to our patients", Dr. Weeks said. "There is a dilemma that we face as doctors who are taking patients and also putting them on clinical trials. With that doctor hat on, you want to do your very best for the patient in front of you. However, with the researcher hat on, you want to generate knowledge that will help the next generation of patients."

Dr. Weeks said that the current findings indicate "a tendency to blur the doctor and researcher" roles. "If you can beilieve that treatment in a clinical trial offers a better outcome than standard therapy the dilemma goes away.

The complete article can be found at Lancet 2001; 358:1772-1777.