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Supportive Care in Cancer

Erschienen in:

01.04.2006 | Review Article

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

verfasst von: A. C. Cox, L. J. Fallowfield, V. A. Jenkins

Erschienen in: Supportive Care in Cancer | Ausgabe 4/2006

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Abstract

Phase 1 (P1) trials are vital to the development of cancer treatments; however, the patients involved in these trials are unlikely to receive any therapeutic benefit, and there are significant possibilities that they will experience serious side effects. Ethical requirements stipulate that patients must be adequately informed before they consent to participate in P1 trials. This review focuses on studies that have measured patient comprehension of information given during the informed consent process of P1 cancer trials. Patients consenting to participate in P1 trials currently have a limited understanding of trial purpose, an unrealistic expectation of the benefits and risks associated with trial participation and a questionable appreciation of their right to abstain or withdraw. Health care professionals recruiting to P1 trials need clear and practical guidelines and training packages designed to ensure that all details of P1 trials are communicated effectively to eligible patients.

World Health Organization (1995) Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. World Health Organization, Geneva

Fallowfield L, Saul J, Gilligan B (2001) Teaching senior nurses how to teach communication skills in oncology. Cancer Nurs 24:185–191PubMedCrossRef

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 330:400PubMedCrossRef

Roberts T, Goulart B, Squitieri L, Stallings S, Halpern 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 292:2130–2140PubMedCrossRef

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

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 13:1062–1072PubMed

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 22:6–14PubMedCrossRef

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

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 76:107–113PubMed

10.

Cox K (2000) Enhancing cancer clinical trial management: recommendations from a qualitative study of trial participants’ experiences. Psychooncology 9:314–322PubMedCrossRef

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 358:1772–1777PubMedCrossRef

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 20:3785–3791PubMedCrossRef

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 100:261–268PubMedCrossRef

14.

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

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 14:984–996PubMed

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 27:1435–1438PubMed

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 24:891–896PubMed

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 91:1949–1955PubMedCrossRef

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 18:421–428PubMed

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 21:2589–2596PubMedCrossRef

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 10:225–231PubMedCrossRef

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 46:31–38PubMedCrossRef

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 347:2134–2140PubMedCrossRef

24.

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

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 11:289–294PubMedCrossRef

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 6:363–369PubMed

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 20:503–513PubMedCrossRef

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 24:329–344PubMedCrossRef

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 103:140–147PubMedCrossRef

31.

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

32.

Meropol NJ, Castel LD, Schulman KA, Weinfurt KP (2004) In reply: J Clin Oncol 22:572–573CrossRef

Titel: Communication and informed consent in phase 1 trials: a review of the literature
verfasst von: A. C. Cox
L. J. Fallowfield
V. A. Jenkins
Publikationsdatum: 01.04.2006
Verlag: Springer-Verlag
Erschienen in: Supportive Care in Cancer / Ausgabe 4/2006
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-005-0916-2

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

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