Communicating and understanding the purpose of pediatric phase I cancer trials

Journal of Clinical Oncology

Volumn 30, Issue 35, 2012, Pages 4367-4372

  Cousino, Melissa K ^a   Zyzanski, Stephen J ^a   Yamokoski, Amy D ^b   Hazen, Rebecca A ^c   Baker, Justin N ^e   Noll, Robert B ^f   Rheingold, Susan R ^g   Geyer, J Russell ^h   Alexander, Stewart C ^i,j   Drotar, Dennis ^d   Kodish, Eric D ^b  

^a CASE WESTERN RESERVE UNIVERSITY   (United States)

^b LERNER RESEARCH INSTITUTE   (United States)

^c CASE WESTERN RESERVE UNIVERSITY   (United States)

^d CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^e ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^f CHILDREN S HOSPITAL OF PITTSBURGH   (United States)

^g CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^h Seattle Children's   (United States)

ⁱ DUKE UNIVERSITY MEDICAL CENTER   (United States)

^j DURHAM VA MEDICAL CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; ARTICLE; CHILD; COMPREHENSION; DOCTOR PATIENT RELATION; DOSE CALCULATION; DRUG DOSE ESCALATION; DRUG SAFETY; ETHNICITY; FEMALE; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; INTERVIEW; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); PARENT; PHASE 1 CLINICAL TRIAL (TOPIC); PHYSICIAN; PRIORITY JOURNAL; SCHOOL CHILD; SOCIAL STATUS;

ADULT; AGED; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; COMMUNICATION; FEMALE; HUMANS; INFANT; INFORMED CONSENT; MALE; MIDDLE AGED; NEOPLASMS; PARENTS; PEDIATRICS; PHYSICIAN-PATIENT RELATIONS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84870731935     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.42.3004     Document Type: Article

References (42)

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 35:484-493, 2008
2. Kodish E: Pediatric ethics and early-phase childhood cancer research: Conflicted goals and the prospect of benefit. Account Res 10:17-25, 2003
3. Shah S, Weitman S, Langevin AM, et al: Phase I therapy trials in children with cancer. J Pediatr Hematol Oncol 20:431-438, 1998 (Pubitemid 29133197)
4. Eisenhauer EA, O'Dwyer PJ, Christian M, et al: Phase I clinical trial design in cancer drug development. J Clin Oncol 18:684-692, 2000 (Pubitemid 30078550)
5. Oberman M, Frader J: Dying children and medical research: Access to clinical trials as benefit and burden. Am J Law Med 29:301-317, 2003 (Pubitemid 39530596)
6. Brody B: Research on the vulnerable sick, in Kahn J, Mastrianni A, Sugarman J (eds): Beyond Consent: Seeking Justice in Research. New York, NY, Oxford University Press, 1998, pp 41-42
7. Daugherty C, Ratain MJ, Grochowski E, et al: Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13:1062-1072, 1995
8. Cox K: 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, 2002
9. Joffe S, Cook EF, Cleary PD, et al: Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 358:1772-1777, 2001 (Pubitemid 33153003)
10. Kodish E, Eder M, Noll RB, et al: Communication of randomization in childhood leukemia trials. JAMA 291:470-475, 2004 (Pubitemid 38129751)
11. Truong TH, Weeks JC, Cook EF, et al: Outcomes of informed consent among parents of children in cancer clinical trials. Pediatr Blood Cancer 57:998-1004, 2011
12. Wolfe J, Klar N, Grier HE, et al: Understanding of prognosis among parents of children who died of cancer. JAMA 284:2469-2475, 2000
13. Appelbaum PS, Roth LH, Lidz C: The therapeutic misconception: Informed consent in psychiatric research. Int J Law Psychiatry 5:319-329, 1982
14. Gordon EJ, Daugherty CK: "Hitting you over the head": Oncologists' disclosure of prognosis to advanced cancer patients. Bioethics 17:142-168, 2003 (Pubitemid 36416572)
15. Miller M: Phase I cancer trials: A collusion of misunderstanding. Hastings Cent Rep 30:34-43, 2000
16. Deatrick JA, Angst DB, Moore C: Parents'views of their children's participation in phase I oncology clinical trials. J Pediatr Oncol Nurs 19:114-121, 2002
17. Estlin EJ, Cotterill S, Pratt CB, et al: Phase I trials in pediatric oncology: Perceptions of pediatricians from the United Kingdom Children's Cancer Study Group and the Pediatric Oncology Group. J Clin Oncol 18:1900-1905, 2000 (Pubitemid 30261927)
18. Lederer SA, Grodin MA: Historical overview: Pediatric experimentation, in Grodin MA, Glantz LH (eds): Children as Research Subjects: Science, Ethics, and Law. New York, NY, Oxford University Press, 1994, pp 3-25
19. Broome ME, Kodish E, Geller G, et al: Children in research: New perspectives and practices for informed consent. IRB 25:S20-S23, 2003 (suppl)
20. Hollingshead AB: Two Factor Index of Social Position. New Haven, CT, Yale University, 1957
21. Angiolillo AL, Simon C, Kodish E, et al: Staged informed consent for a randomized clinical trial in childhood leukemia: Impact on the consent process. Pediatr Blood Cancer 42:433-437, 2004 (Pubitemid 38524473)
22. Cohen J: Statistical Power Analysis for the Behavioral Sciences. Hillsdale, NJ, Lawrence Erlbaum, 1988
23. Joffe S, Cook EF, Cleary PD, et al: Quality of informed consent: A new measure of understanding among research subjects. J Natl Cancer Inst 93:139-147, 2001 (Pubitemid 32111992)
24. 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. http://www.cancer.gov/ clinicaltrials/patientsafety/simplification-of-informed-consent-docs/page2
25. Norman GR, Sloan JA, Wyrwich KW: Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation. Med Care 41:582-592, 2003
26. Daugherty CK, Banik DM, Janish L, et al: Quantitative analysis of ethical issues in phase I trials: A survey interview study of 144 advanced cancer patients. IRB 22:6-14, 2000
27. Pentz RD, White M, Harvey RD, et al: Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials. Cancer [epub ahead of print on January 31, 2012]
28. Fallowfield L, Jenkins V, Farewell V, et al: Efficacy of a cancer research UK communication skills training model for oncologists: A randomised controlled trial. Lancet 359:650-656, 2002 (Pubitemid 34203764)
29. Fallowfield L, Lipkin M, Hall A: Teaching senior oncologists communication skills: Results from phase I of a comprehensive longitudinal program in the United Kingdom. J Clin Oncol 16:1961-1968, 1998 (Pubitemid 28234747)
30. Rao JK, Anderson LA, Inui TS, et al: Communication interventions make a difference in conversations between physicians and patients: A systematic review of the evidence. Med Care 45:340-349, 2007
31. Cousino M, Hazen R, Yamokoski A, et al: Parent participation and physician-parent communication during informed consent in child leukemia. Pediatrics 128:e1544-e1551, 2011
32. Yap TY, Yamokoski A, Noll R, et al: A physician-directed intervention: Teaching and measuring better informed consent. Acad Med 84:1036-1042, 2009
33. Kreicbergs U, Valdimarsdóttir U, Onelöv E, et al: Talking about death with children who have severe malignant disease. N Engl J Med 351:1175-1186, 2004 (Pubitemid 39296305)
34. Nitschke R, Meyer WH, Huszti HC: When the tumor is not the target, tell the children. J Clin Oncol 19:595-596, 2001 (Pubitemid 32112878)
35. Hurwitz CA, Duncan J, Wolfe J: Caring for the child with cancer at the close of life: "There are people who make it, and I'm hoping I'm one of them." JAMA 292:2141-2149, 2004 (Pubitemid 39435105)
36. Hinds PS, Drew D, Oakes LL, et al: End-of-life care preferences of pediatric patients with cancer. J Clin Oncol 23:9146-9154, 2005
37. Eder ML, Yamokoski AD, Wittmann PW, et al: Improving informed consent: Suggestions from parents of children with leukemia. Pediatrics 119:e849-e859, 2007 (Pubitemid 46556648)
38. Kupst MJ, Patenaude AF, Walco GA, et al: Clinical trials in pediatric cancer: Parental perspectives on informed consent. J Pediatr Hematol Oncol 25:787-790, 2003 (Pubitemid 37238768)
39. Levi RB, Marsick R, Drotar D, et al: Diagnosis, disclosure, and informed consent: Learning from parents of children with cancer. J Pediatr Hematol Oncol 22:3-12, 2000 (Pubitemid 32266831)
40. Tait AR, Voepel-Lewis T, Robinson A, et al: Priorities for disclosure of the elements of informed consent for research: A comparison between parents and investigators. Paediatr Anaesth 12:332-336, 2002 (Pubitemid 34534187)
41. Davis TC, Williams MV, Marin E, et al: Health literacy and cancer communication. CA Cancer J Clin 52:134-149, 2002 (Pubitemid 34546106)
42. Hazen RA, Eder M, Drotar D, et al: A feasibility trial of a video intervention to improve informed consent for parents of children with leukemia. Pediatr Blood Cancer 55:113-118, 2010