Supportive Care in Cancer

, Volume 15, Issue 7, pp 829–840

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

  • Elizabeth L. Strevel
  • Colin Newman
  • Gregory R. Pond
  • Martha MacLean
  • Lillian L. Siu
Original Article

DOI: 10.1007/s00520-006-0199-2

Cite this article as:
Strevel, E.L., Newman, C., Pond, G.R. et al. Support Care Cancer (2007) 15: 829. doi:10.1007/s00520-006-0199-2

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.

Keywords

EducationInformed consentPhase I clinical trials

Copyright information

© Springer-Verlag 2006

Authors and Affiliations

  • Elizabeth L. Strevel
    • 1
    • 2
  • Colin Newman
    • 2
  • Gregory R. Pond
    • 2
  • Martha MacLean
    • 1
    • 2
  • Lillian L. Siu
    • 1
    • 2
  1. 1.Division of Medical Oncology and HematologyPrincess Margaret HospitalTorontoCanada
  2. 2.University of TorontoTorontoCanada