The impact of an educational DVD on cancer patients considering participation in a phase I clinical trial

Goals of work: The quality of informed consent in phase I trials is controversial, partially due to gaps in patient understanding. We assessed an educational DVD's impact on knowledge and satisfaction in cancer patients newly referred to a phase I clinic. Materials and methods: Forty-nine patients were randomly assigned to view an educational DVD (n=22) which explained phase I trials or a placebo DVD (n=27). Patients completed a questionnaire assessing knowledge of phase I studies and satisfaction with the DVD. The blinded interviewing physician (n=8) rated the patient's understanding of phase I trials. Main results: The mean patient age was 56; 61% were male. Patients who viewed the educational DVD were less likely to believe that phase I trials determine drug efficacy (p=0.019), more likely to know that phase I drugs have not been thoroughly studied in humans (p=0.003), and less likely to believe that these agents have proven activity against human cancers (p=0.008). More patients who viewed the educational DVD agreed/strongly agreed that the DVD provided useful information (p < 0.001), were confident in their knowledge of phase I trials (p=0.031), felt aided in their decision to enter a phase I study (p=0.011), and would have more questions for their physicians because of the DVD (p=0.017). No statistically significant difference in physician perception of patient understanding or phase I trial accrual was observed between the educational and placebo DVD groups. Conclusions: An educational DVD increased patient knowledge and satisfaction regarding participation in phase I clinical trials.