Patient Education Improves Clinical Trial Participation

The study included 1,255 patients with cancer who were randomly allocated before their initial visit with an oncologist to PRE-ACT (623 patients) or control (632 patients) groups. PRE-ACT included three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient’s barriers. The control group received general clinical trials information produced by the US National Cancer Institute (NCI; Rockville, MD, USA) in text format.

The results showed that both PRE-ACT and control interventions improved knowledge and attitudes compared with baseline. The patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge and a significantly greater decrease in attitudinal barriers than did their text-only (control) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials, with a trend favoring the PRE-ACT group, which was also associated with greater patient satisfaction than NCI text alone. The study was published on December 23, 2015, in the Journal of Clinical Oncology.

“These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials,” concluded lead author Neal J. Meropol, MD, of the UHCMC Seidman Cancer Center, and colleagues. “Both text and tailored video were effective; the PRE-ACT interactive video program was more effective than NCI text in improving knowledge and reducing attitudinal barriers.”

Clinical trials are prospective studies on volunteer human participants designed to answer specific questions about biomedical or behavioral interventions, such as novel vaccines, medical devices, drugs, dietary choices and supplements, or interventions that warrant further study and comparison. The trials are intended to generate data on safety and efficacy, and are conducted only after they have received a national health authority or ethics committee approval, and after being vetted for risk/benefit ratio.

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