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

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

Education Informed consent Phase I clinical trials 

References

  1. 1.
    Agrawal M, Emanuel EJ (2003) Ethics of phase I oncology studies: Reexamining the arguments and data. JAMA 290:1075–1082PubMedCrossRefGoogle Scholar
  2. 2.
    Bain NS, Campbell NC, Ritchie LD et al (2002) Striking the right balance in colorectal cancer care—a qualitative study of rural and urban patients. Fam Pract 19:369–374PubMedCrossRefGoogle Scholar
  3. 3.
    Cheng JD, Hitt J, Koczwara B et al (2000) Impact of quality of life on patient expectations regarding phase I clinical trials. J Clin Oncol 18:421–428PubMedGoogle Scholar
  4. 4.
    Daugherty CK, Banik DM, Janish L et al (2000) Quantitative analysis of ethical issues in phase I trials: a survey interview study of 144 advanced cancer patients. IRB 22:6–14PubMedCrossRefGoogle Scholar
  5. 5.
    Daugherty C, Ratain MJ, Grochowski E et al (1995) Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13:1062–1072PubMedGoogle Scholar
  6. 6.
    Decoster G, Stein G, Holdener EE (1990) Responses and toxic deaths in phase I clinical trials. Ann Oncol 1:145–181Google Scholar
  7. 7.
    Eisenhauer EA, O’Dwyer PJ, Christian M et al (2000) Phase I clinical trial design in cancer drug development. J Clin Oncol 18:684–692PubMedGoogle Scholar
  8. 8.
    Emanuel EJ (1995) A phase I trial on the ethics of phase I trials. J Clin Oncol 13:1049–1051PubMedGoogle Scholar
  9. 9.
    Faden RR, Beauchamp TL, King NMP (1986) A history and theory of informed consent. Oxford University Press, New York, NYGoogle Scholar
  10. 10.
    Flory J, Emanuel E (2004) Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA 292:1593–1601PubMedCrossRefGoogle Scholar
  11. 11.
    Fureman I, Meyers K, McLellan AT et al (1997) Evaluation of a video-supplement to informed consent: injection drug users and preventive HIV efficacy trials. AIDS Educ Prev 9:330–341PubMedGoogle Scholar
  12. 12.
    Hlubocky FJ, Kass NE, Fogarty LA et al (2004) Effects of a CD-ROM educational intervention (CD) on prognosis understanding among advanced cancer patients (acp) enrolling in early phase clinical trials. Proc Am Soc Clin Oncol 22:532s (Abstract 6054)Google Scholar
  13. 13.
    Horstmann E, McCabe MS, Grochow L et al (2005) Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 352:895–904PubMedCrossRefGoogle Scholar
  14. 14.
    Hutchison C (1998) Phase I trials in cancer patients: participants’ perceptions. Eur J Cancer Care 7:15–22CrossRefGoogle Scholar
  15. 15.
    Hutchison C, Campbell S (2002) Evaluation of an information booklet for patients considering participation in phase I clinical trials in cancer. Eur J Cancer Care 11:131–138CrossRefGoogle Scholar
  16. 16.
    Itoh K, Sasaki Y, Fujii H et al (1997) Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations. Br J Cancer 76:107–113PubMedGoogle Scholar
  17. 17.
    Itoh K, Sasaki Y, Miyata Y et al (1994) Therapeutic response and potential pitfalls in phase I clinical trials of anticancer agents conducted in Japan. Cancer Chemother Pharmacol 4:451–454Google Scholar
  18. 18.
    Joffe S, Miller FG (2006) Rethinking risk-benefit assessment for phase I cancer trials. J Clin Oncol 24:2987–2990PubMedCrossRefGoogle Scholar
  19. 19.
    Meade CD (1999) Improving understanding of the informed consent process and document. Sem Oncol Nurs 15:124–137CrossRefGoogle Scholar
  20. 20.
    Meropol NJ, Weinfurt KP, Burnett CB et al (2003) Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician–patient communication. J Clin Oncol 21:2589–2596PubMedCrossRefGoogle Scholar
  21. 21.
    Nitschke R (2004) Physician–patient communication in phase I cancer trials. J Clin Oncol 22:571–572PubMedCrossRefGoogle Scholar
  22. 22.
    Nurgat ZA, Craig W, Campbell NC et al (2005) Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. Br J Cancer 92:1001–1005PubMedCrossRefGoogle Scholar
  23. 23.
    Penman DT, Holland JC, Bahna GF et al (1984) Informed consent for investigational chemotherapy: patients’ and physicians’ perceptions. J Clin Oncol 2:849–855PubMedGoogle Scholar
  24. 24.
    Rajagopal S, Goodman PJ, Tannock IF (1994) Adjuvant chemotherapy for breast cancer: discordance between physicians’ perception of benefit and the results of clinical trials. J Clin Oncol 12:1296–1304PubMedGoogle Scholar
  25. 25.
    Roberts Jr TG, Goulart BH, Squitieri L et al (2004) Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA 292:2130–2140PubMedCrossRefGoogle Scholar
  26. 26.
    Rodenhuis S, van den Heuvel WJA, Annyas AA et al (1984) Patient motivation and informed consent in a phase I study of an anticancer agent. Eur J Cancer Clin Oncol 20:457–462PubMedCrossRefGoogle Scholar
  27. 27.
    Rossi M, McClellan R, Chou L et al (2004) Informed consent for ankle fracture surgery: patient comprehension of verbal and videotaped information. Foot Ankle Int 25:756–762PubMedGoogle Scholar
  28. 28.
    Von Hoff DD, Turner J (1991) Response rates, duration of response, and dose response effects in phase I studies of antineoplastics. Invest New Drugs 9:115–122Google Scholar
  29. 29.
    Weeks JC, Cook EF, O’Day SJ et al (1998) Relationship between cancer patients’ predictions of prognosis and their treatment preferences. JAMA 279:1709–1714PubMedCrossRefGoogle Scholar
  30. 30.
    Weinfurt KP, Castel LD, Li Y et al (2003) The correlation between patient characteristics and expectations of benefit from phase I clinical trials. Cancer 98:166–175PubMedCrossRefGoogle Scholar
  31. 31.
    Weston J, Hannah M, Downes J (1997) Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns 30:239–245PubMedCrossRefGoogle Scholar
  32. 32.
    Wirshing DA, Sergi MJ, Mintz J (2005) A videotape intervention to enhance the informed consent process for medical and psychiatric treatment research. Am J Psychiatr 162:186–188PubMedCrossRefGoogle Scholar
  33. 33.
    Yoder LH, O’Rourke TJ, Etnyre A et al (1997) Expectations and experiences of patients with cancer participating in phase I clinical trials. Oncol Nurs Forum 24:891–896PubMedGoogle Scholar

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

Personalised recommendations