Outcomes of informed consent among parents of children in cancer clinical trials

Pediatric Blood and Cancer

Volumn 57, Issue 6, 2011, Pages 998-1004

  Truong, Tony H ^a   Weeks, Jane C ^b   Cook, E Francis ^c   Joffe, Steven ^b,d  

^a HOSPITAL FOR SICK CHILDREN   (Canada)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d BOSTON CHILDREN S HOSPITAL   (United States)

Author keywords

Clinical trials; Ethics; Informed consent; Outcomes; Participant knowledge

Indexed keywords

ADULT; ARTICLE; ATTITUDE TO HEALTH; CANCER GROWTH; CANCER RELAPSE; CHILDHOOD CANCER; CLINICAL ARTICLE; CLINICAL TRIAL (TOPIC); CONTROLLED STUDY; EDUCATIONAL STATUS; ETHNICITY; FEMALE; HEALTH SURVEY; HUMAN; INFORMED CONSENT; MALE; OUTCOME ASSESSMENT; PARENT; PATIENT SATISFACTION; PHASE 3 CLINICAL TRIAL (TOPIC); PHYSICIAN; PRIORITY JOURNAL; PROGNOSIS; RACE;

ADULT; AGED; CLINICAL TRIALS AS TOPIC; FEMALE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; INFORMED CONSENT; LINEAR MODELS; MALE; MIDDLE AGED; NEOPLASMS; PARENTS; QUESTIONNAIRES; TREATMENT OUTCOME;

EID: 80052669047     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.22983     Document Type: Article

References (25)

1. O'Leary M, Krailo M, Anderson JR, et al. Progress in childhood cancer: 50 years of research collaboration, a report from the Children's Oncology Group. Semin Oncol 2008;35:484-493.
2. Larson RA, Stone RM, Mayer RJ, et al. Fifty years of clinical research by the leukemia committee of the cancer and leukemia group B. Clin Cancer Res 2006;12:3556s-3563s.
3. Bleyer WA. The U.S. pediatric cancer clinical trials programmes: International implications and the way forward. Eur J Cancer 1997;33:1439-1447.
4. Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 2001;358:1772-1777.
5. Lynoe N, Sandlund M, Dahlqvist G, et al. Informed consent: Study of quality of information given to participants in a clinical trial. BMJ 1991;303:610-613.
6. Daugherty C, Ratain MJ, Grochowski E, et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 1995;13:1062-1072.
7. Kodish E, Eder M, Noll RB, et al. Communication of randomization in childhood leukemia trials. JAMA 2004;291:470-475.
8. Taub HA, Baker MT, Sturr JF. Informed consent for research. Effects of readability, patient age, and education. J Am Geriatr Soc 1986;34:601-606.
9. Schaeffer MH, Krantz DS, Wichman A, et al. The impact of disease severity on the informed consent process in clinical research. Am J Med 1996;100:261-268.
10. Kodish ED, Pentz RD, Noll RB, et al. Informed consent in the Childrens Cancer Group: Results of preliminary research. Cancer 1998;82:2467-2481.
11. Olver IN, Buchanan L, Laidlaw C, et al. The adequacy of consent forms for informing patients entering oncological clinical trials. Ann Oncol 1995;6:867-870.
12. Kodish E. Informed consent for pediatric research: Is it really possible? J Pediatr 2003;142:89-90.
13. Smyth RL, Weindling AM. Research in children: Ethical and scientific aspects. Lancet 1999;354:SII21-SII24.
14. Joffe S, Fernandez CV, Pentz RD, et al. Involving children with cancer in decision-making about research participation. J Pediatr 2006;149:862-868.
15. Shilling V, Young B. How do parents experience being asked to enter a child in a randomised controlled trial? BMC Med Ethics 2009;10:1.
16. Pratt CB. The conduct of phase I-II clinical trials in children with cancer. Med Pediatr Oncol 1991;19:304-309.
17. Greenley RN, Drotar D, Zyzanski SJ, et al. Stability of parental understanding of random assignment in childhood leukemia trials: An empirical examination of informed consent. J Clin Oncol 2006;24:891-897.
18. Eder ML, Yamokoski AD, Wittmann PW, et al. Improving informed consent: Suggestions from parents of children with leukemia. Pediatrics 2007;119:e849-e859.
19. Simon CM, Siminoff LA, Kodish ED, et al. Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology. J Clin Oncol 2004;22:2708-2717.
20. Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent: A new measure of understanding among research subjects. J Natl Cancer Inst 2001;93:139-147.
21. Comprehensive Working Group on Informed Consent in Cancer Clinical Trials for the National Cancer Institute. Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials. Bethesda, MD: National Cancer Institute; 1988.
22. Lidz CW, Appelbaum PS, Grisso T, et al. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med 2004;58:1689-1697.
23. Lidz CW, Appelbaum PS, Meisel A. Two models of implementing informed consent. Arch Intern Med 1988;148:1385-1389.
24. Yap TY, Yamokoski A, Noll R, et al. A physician-directed intervention: Teaching and measuring better informed consent. Acad Med 2009;84:1036-1042.
25. Yamokoski AD, Hazen RA, Kodish ED. Anticipatory guidance to improve informed consent: A new application of the concept. J Pediatr Oncol Nurs 2008;25:34-43.