, Volume 15, Issue 7, pp 829-840
Date: 20 Dec 2006

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

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Abstract

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.