title: Clinical trials in pediatric cancer: parental perspectives on informed consent.
abstract: To better understand parental perceptions of the informed consent process in pediatric oncology clinical trials, 20 parents of newly diagnosed children at two pediatric cancer centers described their perceptions in a semi-structured interview. They recalled well the diagnosis, the general treatment plan, and the statistics of survival and/or cure, but the research nature of the clinical trials, particularly randomization, was not well understood. However, despite the need to assimilate a great deal of information, time pressure to make decisions, and reportedly high levels of distress during the discussions, parents expressed general satisfaction with the informed consent discussions with their pediatric oncology providers. However, half to two thirds of parents felt there had been inadequate discussion of alternatives to the proposed treatment and of the research nature of the protocol. While further study of the informed consent process should be conducted in larger, representative samples, the findings from this pilot study suggest that a goal of future informed consent interventions should be to improve parents' understanding of the research aspects of treatment. It is critical to parents' ability to provide informed consent that they feel satisfied that they know alternatives to proposed treatment and that they understand the randomization of treatments, which is the gold standard of clinical trials in pediatric oncology.
authors.affiliation: Department of Pediatrics, Medical College of Wisconsin and Midwest Children's Cancer Center, Milwaukee, Wisconsin 53226, USA. mkupst@mcw.edu
authors.forename: Mary Jo
authors.initials: MJ
authors.lastname: Kupst
authors.forename: Andrea Farkas
authors.initials: AF
authors.lastname: Patenaude
authors.forename: Gary A
authors.initials: GA
authors.lastname: Walco
authors.forename: Cheryl
authors.initials: C
authors.lastname: Sterling
mesh_terms: D000293:Adolescent; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods* / Q000523:psychology* / Q000592:standards; D003657:Decision Making; D005260:Female; D006266:Health Education; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D009369:Neoplasms / Q000188:drug therapy*; D033282:Parental Consent / Q000941:ethics / Q000523:psychology*; D010290:Parents / Q000523:psychology*; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D010818:Practice Patterns, Physicians'; D011897:Random Allocation; D012107:Research Design; D012189:Retrospective Studies; D013312:Stress, Physiological