European Journal of Cancer
Volume 36, Issue 16 , Pages 2096-2104 , October 2000

Information and communication in the context of a clinical trial

  • P. Hietanen

      Affiliations

    • Department of Oncology, University Hospital of Helsinki, PO Box 180, Fin-00029, Finland
    • Corresponding Author InformationCorresponding author. Tel.: +358-94711; fax: +358-947174203
    • ,
  • A.R. Aro

      Affiliations

    • Department of Epidemiology and Health Promotion, National Public Health Institute, Helsinki, Finland
    • ,
  • K. Holli

      Affiliations

    • Department of Oncology, University Hospital of Tampere, Finland
    • ,
  • P. Absetz

      Affiliations

    • Department of Epidemiology and Health Promotion, National Public Health Institute, Helsinki, Finland

Received 17 December 1999 ,Revised 10 April 2000 ,Accepted 28 June 2000.

References 

  1. Howard-Jones N. Human experimentation in historical and ethical perspectives. Soc. Sci. Med. 1982;16:1429–1448
  2. World Medical Association. Declaration of Helsinki: Recommendations for Guiding Medical Doctors in Biomedical Research Involving Human Subjects. Helsinki, World Medical Association, 1964.
  3. Edwards SJL, Lilford RJ, Thornton J, Hewison J. Informed consent for clinical trials (in search of the best method). Soc. Sci. Med. 1998;47:1825–1840
  4. Gotay CC. Accrual to cancer clinical trials (directions from the research literature). Soc. Sci. Med. 1991;33:569–577
  5. Ganz PA. Clinical trials. Concerns of the patient and the public. Cancer. 1990;65:2394–2399
  6. Verheggen F, Jonkers R, Kok G. Patient's perceptions of informed consent and the quality of information disclosure in clinical trials. Pat. Educ. Counsel. 1996;29:137–153
  7. Penman DT, Holland JC, Bahna GF, et al.  Informed consent for investigational chemotherapy (patients’ and physicians perceptions). J. Clin. Oncol. 1984;2:849–855
  8. Cassileth BR, Zupkis RB, Sutton-Smith K, March V. Informed consent (why are its goals imperfectly realised?). N. Engl. J. Med. 1980;302:896–9000
  9. Muss HB, White DR, Michielutte R, et al.  Written informed consent in patients with breast cancer. Cancer. 1979;43:1549–1556
  10. White DR, Muss HB, Michielutte R, et al.  Informed consent (patient information forms in chemotherapy trials). Am. J. Clin. Oncol. 1984;7:183–190
  11. Aaronson NK, Visserpol E, Leenhouts GHMW, et al.  Telephone-based nursing and intervention improves the effectiveness of the informed consent process in cancer clinical trials. J. Clin. Oncol. 1996;14:984–996
  12. Tindal B, Forde S, Ross MW, Goldstein D, Barker S, Cooper DA. Effects of two formats of informed consent on knowledge amongst persons with advanced HIV disease in a clinical trial of didanosine. Pat. Educ. Counsel. 1994;24:261–266
  13. Grossman SA, Piantadosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families?. J. Clin. Oncol. 1994;12:2211–2215
  14. LoVerde ME, Prochazka AV, Byyny RL. Research consent forms (continued unreadability and increasing length). J. Gen. Intern. Med. 1989;4:410–412
  15. Morrow G. How readable are subject consent forms?. J. Am. Med. Assoc. 1980;244:56–58
  16. Priestly KA, Cambell C, Valentine CB, et al.  Are patient consent forms for research protocols easy to read?. Br. Med. J. 1992;305:1263–1264
  17. Street RL. Information-giving in medical consultations (the influence of patients’ communicative styles and personal characteristics). Soc. Sci. Med. 1991;32:541–548
  18. Bochner S. Doctors, patients, and their cultures. In:  Dendleton D,  Hasler J editor. Doctor–Patient Communication. New York, NY: Academic Press; 1983;
  19. Jenkins VA, Fallowfield LJ, Souhami A, Sawtell M. How do doctors explain randomised clinical trials to their patients?. Eur. J. Cancer. 1999;35:1187–1193
  20. Taylor KM, Kelner M. Informed consent (the Physicians’ perspective). Soc. Sci. Med. 1987;24:135–143
  21. Williams CJ, Zwitter M. Informed consent in European multicenter randomised clinical trials — are patients really informed. Eur. J. Cancer. 1994;30A:907–910
  22. Howard JM, DeMets D. The BHAT Research Group. How Informed is informed consent?. Controlled Clin. Trials. 1981;2:287–303
  23. Simes RJ, Tattarsell MHN, Coates AS, Raghavan D, Solomon HJ, Smartt H. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment of cancer. Br. Med. J. 1986;293:1065–1068
  24. DCCT Research Group . Implementation of a multicomponent process to obtain informed consent in a diabetes control and complications trial. Controlled Clin. Trials. 1989;10:83–96
  25. Jensen AB, Madsen B, Anderson P, Rose C. Information for cancer patients entering a clinical trial (evaluation of an information strategy). Eur. J. Cancer. 1993;29A:2235–2238
  26. Helman CG. Communication in primary care (the role of patient and practitioner explanatory models). Soc. Sci. Med. 1985;20:923–931
  27. Slevin M, Mossman J, Bowling A, et al.  Volunteers or victims (patients’ views of randomised cancer clinical trials). Br. J. Cancer. 1995;71:1270–1274
  28. Albrecht T, Blanchard C, Ruckdeschel JC, Coovert M, Strongbow R. Strategic physician communication and oncology clinical trials. J. Clin. Oncol. 1999;17:3324–3332
  29. Fallowfield L, Jenkins V. Effective communication skills are the key to good cancer care. Eur. J. Cancer. 1999;35:1592–1597

PII: S0959-8049(00)00191-X

European Journal of Cancer
Volume 36, Issue 16 , Pages 2096-2104 , October 2000

Article Tools