Communication and informed consent in phase 1 trials: A review of the literature

Supportive Care in Cancer

Volumn 14, Issue 4, 2006, Pages 303-309

  Cox, A C ^a   Fallowfield, L J ^a   Jenkins, V A ^a  

^a UNIVERSITY OF SUSSEX   (United Kingdom)

Author keywords

Communication; Informed consent; Phase 1 trials

Indexed keywords

CANCER CHEMOTHERAPY; CANCER PALLIATIVE THERAPY; CANCER PATIENT; CLINICAL TRIAL; COMPREHENSION; ETHICS; HEALTH PRACTITIONER; HUMAN; INFORMED CONSENT; PATIENT RIGHT; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; VERBAL COMMUNICATION;

CLINICAL TRIALS, PHASE I; COMMUNICATION; GREAT BRITAIN; HUMANS; INFORMED CONSENT; NEOPLASMS;

EID: 33646418976     PISSN: 09414355     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00520-005-0916-2     Document Type: Review

References (32)

1. World Health Organization (1995) Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. World Health Organization, Geneva
2. Fallowfield L, Saul J, Gilligan B (2001) Teaching senior nurses how to teach communication skills in oncology. Cancer Nurs 24:185-191
3. Jenkins V, Fallowfield L, Solis-Trapala I, Langridge C, Farewell V (2005) Discussing randomised clinical trials of cancer therapy: evaluation of a cancer research UK training programme. BMJ 330:400
4. Roberts T, Goulart B, Squitieri L, Stallings S, Halpem E, Chabner B, Gazelle G, Finklestein SJWC (2004) Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA 292:2130-2140
5. Agrawal M, Emanuel EJ (2003) Ethics of phase 1 oncology studies: reexamining the arguments and data. JAMA 290:1075-1082
6. Daugherty C, Ratain MJ, Grochowski E, Stocking C, Kodish E, Mick R, Siegler M (1995) Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13:1062-1072
7. Daugherty CK, Banik DM, Janish L, Ratain MJ (2000) Quantitative analysis of ethical issues in phase I trials: a survey interview of 144 advanced cancer patients. IRB 22:6-14
8. Daugherty C, Kass N, Fogarty LA, Sugarman J, Hlubocky F (2003) A randomized trial of a CD-ROM educational intervention for advanced cancer patients (acp) enrolling in early phase trials. Proc Am Soc Clin Oncol 22:521
9. Itoh K, Sasaki Y, Fujii H, Ohtsu T, Wakita H, Igarashi T, Abe K (1997) Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations. Br J Cancer 76:107-113
10. Cox K (2000) Enhancing cancer clinical trial management: recommendations from a qualitative study of trial participants' experiences. Psychooncology 9:314-322
11. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC (2001) Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 358:1772-1777
12. Pentz RD, Flamm AL, Sugarman J, Cohen MZ, Daniel Ayers G, Herbst RS, Abbruzzese JL (2002) Study of the media's potential influence on prospective research participants' understanding of and motivations for participation in a high-profile phase I trial. J Clin Oncol 20:3785-3791
13. Schaeffer MH, Krantz DS, Wichman A, Masur H, Reed E, Vinicky JK (1996) The impact of disease severity on the informed consent process in clinical research. Am J Med 100:261-268
14. Flory J, Emanuel E (2004) Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA 292:1593-1601
15. Aaronson N, Visser-Pol E, Leenhouts G, Muller M, van der Schot A, van Dam F, Keus R, Koning C, ten Bokkel Huinink W, van Dongen J, Dubbelman R (1996) Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol 14:984-996
16. Schutta KM, Burnett CB (2000) Factors that influence a patient's decision to participate in a phase I cancer clinical trial. Oncol Nurs Forum 27:1435-1438
17. Yoder LH, O'Rourke TJ, Etnyre A, Spears DT, Brown TD (1997) Expectations and experiences of patients with cancer participating in phase I clinical trials. Oncol Nurs Forum 24:891-896
18. Cohen L, de Moor C, Amato RJ (2001) The association between treatment-specific optimism and depressive symptomatology in patients enrolled in a phase I cancer clinical trial. Cancer 91:1949-1955
19. Cheng JD, Hitt J, Koczwara B, Schulman KA, Burnett CB, Gaskin DJ, Rowland JH, Meropol NJ (2000) Impact of quality of life on patient expectations regarding phase I clinical trials. J Clin Oncol 18:421-428
20. Meropol NJ, Weinfurt KP, Burnett CB, Balshem A, Benson AB, 3rd, Castel L, Corbett S, Diefenbach M, Gaskin D, Li Y, Manne S, Marshall J, Rowland JH, Slater E, Sulmasy DP, Van Echo D, Washington S, Schulman KA (2003) Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication. J Clin Oncol 21:2589-2596
21. Henderson GE, Davis AM, King NM, Easter MM, Zimmer CR, Rothschild BB, Wilfond BS, Nelson DK, Churchill LR (2004) Uncertain benefit: investigators' views and communications in early phase gene transfer trials. Mol Ther 10:225-231
22. Cox K (2002) Informed consent and decision-making: patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials. Patient Educ Couns 46:31-38
23. Horng S, Emanuel EJ, Wilfond B, Rackoff J, Martz K, Grady C (2002) Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med 347:2134-2140
24. Hutchison C (1998) Phase I trials in cancer patients: participants' perceptions. Eur J Cancer Care (Engl) 7:15-22
25. Tomamichel M, Jaime H, Degrate A, de Jong J, Pagani O, Cavalli F, Sessa C (2000) Proposing phase I studies: patients', relatives', nurses' and specialists' perceptions. Ann Oncol 11:289-294
26. Tomamichel M, Sessa C, Herzig S, de Jong J, Pagani O, Willems Y, Cavalli F (1995) Informed consent for phase I studies: evaluation of quantity and quality of information provided to patients. Ann Oncol 6:363-369
27. Gattellari M, Voigt KJ, Butow PN, Tattersall MHN (2002) When the treatment goal is not cure: are cancer patients equipped to make informed decisions? J Clin Oncol 20:503-513
28. http://www.cancerbacup.org.uk
29. Weinfurt KP, Sulmasy DP, Schulman KA, Meropol NJ (2003) Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception. Theor Med Bioeth 24:329-344
30. Weinfurt KP, Depuy V, Castel LD, Sulmasy DP, Schulman KA, Meropol NJ (2005) Understanding of an aggregate probability statement by patients who are offered participation in phase I clinical trials. Cancer 103:140-147
31. Nitschke R (2004) Physician-patient communication in phase I cancer trials. J Clin Oncol 22:571-572
32. Meropol NJ, Castel LD, Schulman KA, Weinfurt KP (2004) In nnreply: J Clin Oncol 22:572-573