(ChemotherapyAdvisor) – Patients with cancer and a negative attitude regarding clinical trials — i.e., that “being in a clinical trial is likely to cause a patient harm” — who undergo a brief psychoeducational intervention are more willing to participate than those who receive only printed education, according to a multicenter randomized study reported in the Journal of Clinical Oncology online May 21.
One important contributor to low rates of participation in clinical trials is negative attitudes of patients with cancer. In addition to whether a brief psychoeducation intervention would be effective in improving such attitudes, this study also evaluated patient “knowledge, self-efficacy for decision making, receptivity to receiving more information, and general willingness to participate in clinical trials,” the investigators wrote.
They randomly assigned 472 adults with cancer who had not been asked previously to participate in a clinical trial to receive printed educational information (n=238) about clinical trials or a psychoeducational intervention (n=234) “that provided similar information and also addressed misperceptions and concerns about clinical trials.” Patients self-reported their attitudes (primary outcome), and knowledge, self-efficacy, receptivity, and willingness (secondary outcomes), before assignment and 7 to 28 days later.
Immediately after being randomly assigned, patients in the psychoeducational intervention group viewed a 10-minute DVD, which they could keep, along with a 16-page booklet that reinforced the key points of the DVD. “…in addition to providing information, the DVD addressed misperceptions and concerns about clinical trials (e.g., they are offered only as a last resort) and described how clinical trials can result in more effective cancer treatments,” the investigators reported. “Patients and physicians served as spokespersons and provided recommendations that patients ask their physicians about clinical trials and, if eligible, consider carefully whether to participate. To communicate this last point, the DVD featured patients describing reasons why they did or did not choose to participate in a clinical trial.”
Patients in the educational information alone group were asked to read a 16-page National Cancer Institute (NCI) booklet, “Taking Part in Cancer Treatment Research Studies,” which they could keep. “This booklet consists primarily of educational information about the nature and conduct of clinical trials,” they wrote.
At follow-up, the group that received the psychoeducational intervention demonstrated more positive attitudes toward clinical trials (P=0.016) and a greater willingness to participate (P=0.011) than the group receiving only the NCI booklet.
“Evidence of an indirect effect of intervention assignment on willingness to participate (estimated at 0.168) suggested that the benefits of psychoeducation on willingness to participate were explained by the positive impact of psychoeducation on attitudes toward clinical trials,” they wrote.
“Findings support conducting additional research to evaluate effects of this intervention on quality of decision making and rates of participation among patients asked to enroll onto therapeutic clinical trials,” the investigators concluded.