Informed consent requires further study, and pediatric oncology is the ideal context for the conduct of such research. The primary goal of this study is to improve the quality of informed consent for childhood cancer trials. The project will take place as a limited-institution study within the Children's Oncology Group, the single pediatric member of the NCI's Clinical Trials Cooperative Group Program. The long-term objective will be to capitalize on our understanding of consent to yield generalizable findings that can be implemented to improve consent in clinical trials across various diseases and all age groups. The research plan is based on the premise that specific outcome measures and rigorous scientific methodology are required to accurately study the complex interaction that is informed consent. The work accomplished to date has allowed us to refine this methodology, select key outcome measures, and develop rational intervention plans; it is the foundation upon which this competitive renewal proposal is based.
The Specific Aims of the project are: 1) To utilize our scientific understanding of the informed consent process in childhood leukemia trials to further develop, test and implement two databased interventions to improve informed consent: a) a physician-directed intervention based on teaching improved management of the informed consent conference, and b) a parent-directed intervention based on the model of anticipatory guidance for informed consent; 2) To conduct a clinical trial to test the effect of each intervention on three specific outcomes: a) parental comprehension of choice and alternative to clinical trial participation, b) parental understanding of randomization, and c) parental participation during the informed consent process as measured by the number and quality of questions asked by parents, and; 3) To determine if either intervention is superior to a control group, and how the two interventions compare to one another. This clinical trial of two rational, data-driven interventions will allow us to act on what we have learned, to determine whether we can improve informed consent.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA083267-06
Application #
6718497
Study Section
Special Emphasis Panel (ZRG1-SNEM-1 (04))
Program Officer
Wu, Roy S
Project Start
1999-01-21
Project End
2004-10-31
Budget Start
2004-03-01
Budget End
2004-10-31
Support Year
6
Fiscal Year
2004
Total Cost
$743,960
Indirect Cost
Name
Case Western Reserve University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
Cousino, Melissa; Hazen, Rebecca; Yamokoski, Amy et al. (2011) Parent participation and physician-parent communication during informed consent in child leukemia. Pediatrics 128:e1544-51
Hazen, Rebecca A; Eder, Michelle; Drotar, Dennis et al. (2010) A feasibility trial of a video intervention to improve informed consent for parents of children with leukemia. Pediatr Blood Cancer 55:113-8
Ramirez, Lisa Ysela; Huestis, Samantha E; Yap, Tsiao Yi et al. (2009) Potential chemotherapy side effects: what do oncologists tell parents? Pediatr Blood Cancer 52:497-502
Yap, Tsiao Yi; Yamokoski, Amy; Noll, Robert et al. (2009) A physician-directed intervention: teaching and measuring better informed consent. Acad Med 84:1036-42
Yamokoski, Amy D; Hazen, Rebecca A; Kodish, Eric D (2008) Anticipatory guidance to improve informed consent: a new application of the concept. J Pediatr Oncol Nurs 25:34-43
Hazen, Rebecca A; Drotar, Dennis; Kodish, Eric (2007) The role of the consent document in informed consent for pediatric leukemia trials. Contemp Clin Trials 28:401-8
Eder, Michelle L; Yamokoski, Amy D; Wittmann, Peter W et al. (2007) Improving informed consent: suggestions from parents of children with leukemia. Pediatrics 119:e849-59
Greenley, Rachel Neff; Drotar, Dennis; Zyzanski, Stephen J et al. (2006) Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent. J Clin Oncol 24:891-7
Simon, Christian; Eder, Michelle; Kodish, Eric et al. (2006) Altruistic discourse in the informed consent process for childhood cancer clinical trials. Am J Bioeth 6:40-7
Joffe, Steven; Fernandez, Conrad V; Pentz, Rebecca D et al. (2006) Involving children with cancer in decision-making about research participation. J Pediatr 149:862-868

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