Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem

Supportive Care in Cancer

Volumn 19, Issue 3, 2011, Pages 371-379

  Jefford, M ^b,c   Mileshkin, L ^b   Matthews, J ^a   Raunow, H ^a   O'Kane, C ^a   Cavicchiolo, T ^a   Brasier, H ^a   Anderson, M ^a   Reynolds, J ^a  

^a Cancer Trials Australia   (Australia)

^b UNIVERSITY OF MELBOURNE   (Australia)

^c PETER MACCALLUM CANCER CENTRE   (Australia)

Author keywords

Clinical trials; Comprehension; Informed consent; Physician patient relations; Satisfaction

Indexed keywords

ADULT; AGED; ANXIETY; ARTICLE; COMPREHENSION; DEPRESSION; FEMALE; HUMAN; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; PATIENT DECISION MAKING; PATIENT INFORMATION; PATIENT PREFERENCE; PATIENT SATISFACTION; PRIORITY JOURNAL; QUALITY OF LIFE; SELF REPORT;

ADULT; AGED; AGED, 80 AND OVER; CLINICAL TRIALS AS TOPIC; DECISION MAKING; FEMALE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; NEOPLASMS; PATIENT PARTICIPATION; PATIENT SATISFACTION; PATIENT SELECTION; QUALITY OF LIFE; RESEARCH SUBJECTS;

EID: 79952252742     PISSN: 09414355     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00520-010-0829-6     Document Type: Article

References (30)

1. J Moreno AL Caplan PR Wolpe 1998 Updating protections for human subjects involved in research. Project on Informed Consent, Human Research Ethics Group JAMA 280 1951 1958 9851484 1:STN:280:DyaK1M%2Fms1yjuw%3D%3D (Pubitemid 28559816)
2. EJ Emanuel D Wendler C Grady 2000 What makes clinical research ethical? JAMA 283 2701 2711 10819955 1:STN:280:DC%2BD3c3otVSmsQ%3D%3D (Pubitemid 30337334)
3. Beauchamp TL, Childress JF (2001) Principles of Biomedical Ethics, 5th edn. Oxford University Press, New York
4. M Jefford R Moore 2008 Improvement of informed consent and the quality of consent documents Lancet Oncol 9 485 493 18452859 (Pubitemid 351597797)
5. C Daugherty MJ Ratain E Grochowski C Stocking E Kodish R Mick M Siegler 1995 Perceptions of cancer patients and their physicians involved in phase I trials J Clin Oncol 13 1062 1072 7738612 1:STN:280:DyaK2M3ls12htw%3D%3D
6. CK Daugherty 1999 Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective J Clin Oncol 17 1601 1617 10334550 1:STN:280:DyaK1M3msFOiuw%3D%3D (Pubitemid 29220871)
7. National Breast Cancer Centre and National Cancer Control Initiative (2003) Clinical practice guidelines for the psychosocial care of adults with cancer. National Breast Cancer Centre, Camperdown, NSW, Australia
8. J Flory E Emanuel 2004 Interventions to improve research participants' understanding in informed consent for research: a systematic review JAMA 292 1593 1601 15467062 1:CAS:528:DC%2BD2cXot1Chtr0%3D (Pubitemid 39314966)
9. CA Coyne R Xu P Raich K Plomer M Dignan LB Wenzel D Fairclough T Habermann L Schnell S Quella D Cella 2003 Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group J Clin Oncol 21 836 842 12610182 (Pubitemid 46606443)
10. TC Davis RF Holcombe HJ Berkel S Pramanik SG Divers 1998 Informed consent for clinical trials: a comparative study of standard versus simplified forms J Natl Cancer Inst 90 668 674 9586663 1:STN:280:DyaK1c3ks1Sktw%3D%3D (Pubitemid 28222140)
11. S Joffe EF Cook PD Cleary JW Clark JC Weeks 2001 Quality of informed consent: a new measure of understanding among research subjects J Natl Cancer Inst 93 139 147 11208884 1:STN:280:DC%2BD3M7nvF2lug%3D%3D (Pubitemid 32111992)
12. S Joffe EF Cook PD Cleary JW Clark JC Weeks 2001 Quality of informed consent in cancer clinical trials: a cross-sectional survey Lancet 358 1772 1777 11734235 1:STN:280:DC%2BD3MnoslOktQ%3D%3D (Pubitemid 33153003)
13. NK Aaronson S Ahmedzai B Bergman M Bullinger A Cull NJ Duez A Filiberti H Flechtner SB Fleishman JC de Haes, et al. 1993 The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology J Natl Cancer Inst 85 365 376 8433390 1:STN:280:DyaK3s7msVarsQ%3D%3D (Pubitemid 23073154)
14. AS Zigmond RP Snaith 1983 The hospital anxiety and depression scale Acta Psychiatr Scand 67 361 370 6880820 1:STN:280:DyaL3s3nvFWjug%3D%3D (Pubitemid 13098606)
15. M Holmes-Rovner J Kroll N Schmitt DR Rovner ML Breer ML Rothert G Padonu G Talarczyk 1996 Patient satisfaction with health care decisions: the satisfaction with decision scale Med Decis Making 16 58 64 8717600 1:STN:280:DyaK28zkt1yksg%3D%3D (Pubitemid 26017908)
16. FW Verheggen R Jonkers G Kok 1996 Patients' perceptions on informed consent and the quality of information disclosure in clinical trials Patient Educ Couns 29 137 153 9006231 1:STN:280:DyaK2s7lvVyksQ%3D%3D (Pubitemid 26379289)
17. VA Jenkins LJ Fallowfield A Souhami M Sawtell 1999 How do doctors explain randomised clinical trials to their patients? Eur J Cancer 35 1187 1193 10615228 1:STN:280:DC%2BD3c%2Fot1Sqsg%3D%3D (Pubitemid 29359177)
18. E Kodish M Eder RB Noll K Ruccione B Lange A Angiolillo R Pentz S Zyzanski LA Siminoff D Drotar 2004 Communication of randomization in childhood leukemia trials JAMA 291 470 475 14747504 1:CAS:528:DC%2BD2cXos12msg%3D%3D (Pubitemid 38129751)
19. PN Butow RF Brown MH Tattersall 2000 Ethics of clinical trials N Engl J Med 342 978 10744495 1:STN:280:DC%2BD3c7otlWitw%3D%3D author reply 979-80
20. N Lynoe M Sandlund L Jacobsson 1996 Clinical cancer research-some aspects on doctors' attitudes to informing participants Acta Oncol 35 749 754 8938225 1:STN:280:DyaK2s%2Fpt1yjtw%3D%3D (Pubitemid 26366736)
21. RJ Simes MH Tattersall AS Coates D Raghavan HJ Solomon H Smartt 1986 Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer Br Med J (Clin Res Ed) 293 1065 1068 1:STN:280:DyaL2s%2FislersQ%3D%3D (Pubitemid 17201411)
22. NK Aaronson E Visser-Pol GH Leenhouts MJ Muller AC van der Schot FS van Dam RB Keus CC Koning WW ten Bokkel Huinink JA van Dongen R Dubbelman 1996 Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials J Clin Oncol 14 984 996 8622050 1:STN:280:DyaK287os1ahug%3D%3D (Pubitemid 26085547)
23. RF Brown PN Butow DG Butt AR Moore MH Tattersall 2004 Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials Soc Sci Med 58 379 390 14604623 1:STN:280:DC%2BD3srislyltQ%3D%3D (Pubitemid 37353050)
24. RF Brown PN Butow F Boyle MH Tattersall 2007 Seeking informed consent to cancer clinical trials; evaluating the efficacy of doctor communication skills training Psychooncology 16 507 516 16986176 1:STN:280:DC%2BD2szlt1Wnug%3D%3D (Pubitemid 47039551)
25. I Juraskova P Butow AL Lopez M Seccombe F Boyle N McCarthy JF Forbes 2007 Improving informed consent in clinical trials: successful piloting of a decision aid J Clin Oncol 25 1443 1444 17416867 (Pubitemid 46706896)
26. RF Brown PN Butow SM Dunn MH Tattersall 2001 Promoting patient participation and shortening cancer consultations: a randomised trial Br J Cancer 85 1273 1279 11720460 1:STN:280:DC%2BD3MnnsVyltw%3D%3D (Pubitemid 33081919)
27. E Beardsley M Jefford L Mileshkin 2007 Longer consent forms for clinical trials compromise patient understanding: so why are they lengthening? J Clin Oncol 25 e13 e14 17369564
28. ML Eder AD Yamokoski PW Wittmann ED Kodish 2007 Improving informed consent: suggestions from parents of children with leukemia Pediatrics 119 e849 e859 17403829
29. MC Silva JM Sorrell 1988 Enhancing comprehension of information for informed consent: a review of empirical research IRB 10 1 5 11658988
30. CC Doak LG Doak GH Friedell CD Meade 1998 Improving comprehension for cancer patients with low literacy skills: strategies for clinicians CA Cancer J Clin 48 151 162 9594918 1:STN:280:DyaK1c3lslaktg%3D%3D (Pubitemid 28383261)