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


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.


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.
Strevel
Elizabeth L
EL
Division of Medical Oncology and Hematology, Princess Margaret Hospital, 610 University Avenue, Suite 5-718, Toronto, ON M5G 2M9, Canada.
Newman
Colin
C
Pond
Gregory R
GR
MacLean
Martha
M
Siu
Lillian L
LL
D000970:Antineoplastic Agents / Q000627:therapeutic use; D004522:Educational Status; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010353:Patient Education as Topic / Q000379:methods*; D010358:Patient Participation; D017060:Patient Satisfaction; D010465:Perception; D015397:Program Evaluation; D014743:Videotape Recording
D000970:Antineoplastic Agents