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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.

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References

  1. Agrawal M, Emanuel EJ (2003) Ethics of phase I oncology studies: Reexamining the arguments and data. JAMA 290:1075–1082

    Article  PubMed  Google Scholar 

  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 19:369–374

    Article  PubMed  Google Scholar 

  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 18:421–428

    PubMed  CAS  Google Scholar 

  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 22:6–14

    Article  PubMed  CAS  Google Scholar 

  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 13:1062–1072

    PubMed  CAS  Google Scholar 

  6. Decoster G, Stein G, Holdener EE (1990) Responses and toxic deaths in phase I clinical trials. Ann Oncol 1:145–181

    Google Scholar 

  7. Eisenhauer EA, O’Dwyer PJ, Christian M et al (2000) Phase I clinical trial design in cancer drug development. J Clin Oncol 18:684–692

    PubMed  CAS  Google Scholar 

  8. Emanuel EJ (1995) A phase I trial on the ethics of phase I trials. J Clin Oncol 13:1049–1051

    PubMed  CAS  Google Scholar 

  9. Faden RR, Beauchamp TL, King NMP (1986) A history and theory of informed consent. Oxford University Press, New York, NY

    Google Scholar 

  10. Flory J, Emanuel E (2004) Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA 292:1593–1601

    Article  PubMed  CAS  Google Scholar 

  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 9:330–341

    PubMed  CAS  Google Scholar 

  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. Horstmann E, McCabe MS, Grochow L et al (2005) Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 352:895–904

    Article  PubMed  CAS  Google Scholar 

  14. Hutchison C (1998) Phase I trials in cancer patients: participants’ perceptions. Eur J Cancer Care 7:15–22

    Article  CAS  Google Scholar 

  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 11:131–138

    Article  CAS  Google Scholar 

  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 76:107–113

    PubMed  CAS  Google Scholar 

  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 4:451–454

    Google Scholar 

  18. Joffe S, Miller FG (2006) Rethinking risk-benefit assessment for phase I cancer trials. J Clin Oncol 24:2987–2990

    Article  PubMed  Google Scholar 

  19. Meade CD (1999) Improving understanding of the informed consent process and document. Sem Oncol Nurs 15:124–137

    Article  CAS  Google Scholar 

  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 21:2589–2596

    Article  PubMed  Google Scholar 

  21. Nitschke R (2004) Physician–patient communication in phase I cancer trials. J Clin Oncol 22:571–572

    Article  PubMed  Google Scholar 

  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 92:1001–1005

    Article  PubMed  CAS  Google Scholar 

  23. Penman DT, Holland JC, Bahna GF et al (1984) Informed consent for investigational chemotherapy: patients’ and physicians’ perceptions. J Clin Oncol 2:849–855

    PubMed  CAS  Google Scholar 

  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 12:1296–1304

    PubMed  CAS  Google Scholar 

  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 292:2130–2140

    Article  PubMed  CAS  Google Scholar 

  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 20:457–462

    Article  PubMed  CAS  Google Scholar 

  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 25:756–762

    PubMed  Google Scholar 

  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 9:115–122

    Google Scholar 

  29. Weeks JC, Cook EF, O’Day SJ et al (1998) Relationship between cancer patients’ predictions of prognosis and their treatment preferences. JAMA 279:1709–1714

    Article  PubMed  CAS  Google Scholar 

  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 98:166–175

    Article  PubMed  Google Scholar 

  31. Weston J, Hannah M, Downes J (1997) Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns 30:239–245

    Article  PubMed  CAS  Google Scholar 

  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 162:186–188

    Article  PubMed  Google Scholar 

  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 24:891–896

    PubMed  CAS  Google Scholar 

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Acknowledgment

The authors would like to thank Dr. Ignacio Duran and Dr. Carol Townsley who provided useful advice in the development of the educational DVD tool for this study.

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Authors and Affiliations

  1. Division of Medical Oncology and Hematology, Princess Margaret Hospital, 610 University Avenue, Suite 5-718, Toronto, ON M5G 2M9, Canada

    Elizabeth L. Strevel, Martha MacLean & Lillian L. Siu

  2. University of Toronto, Toronto, Canada

    Elizabeth L. Strevel, Colin Newman, Gregory R. Pond, Martha MacLean & Lillian L. Siu

Authors
  1. Elizabeth L. Strevel
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  2. Colin Newman
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  3. Gregory R. Pond
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  4. Martha MacLean
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  5. Lillian L. Siu
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Corresponding author

Correspondence to Lillian L. Siu.

Appendices

Appendix I: Patient post-DVD survey

Appendix II: Physician post-DVD survey

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Strevel, E.L., Newman, C., Pond, G.R. et al. The impact of an educational DVD on cancer patients considering participation in a phase I clinical trial. Support Care Cancer 15, 829–840 (2007). https://doi.org/10.1007/s00520-006-0199-2

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  • DOI: https://doi.org/10.1007/s00520-006-0199-2

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