Originally published as JCO Early Release 10.1200/JCO.2008.21.1813 on April 13 2009

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Pediatric Cancer Survivorship Research: Experience of the Childhood Cancer Survivor Study

From the Cancer Prevention and Clinical Statistics Programs, Fred Hutchinson Cancer Research Center, Seattle, WA; Emory University, Atlanta, GA; St Jude Children's Research Hospital, Memphis; Vanderbilt University Medical Center, Nashville, TN; The University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Minnesota Medical School, Minneapolis, MN; International Epidemiology Institute, Rockville, MD; and the University of Alberta, Edmonton, Alberta, Canada.

Corresponding author: Wendy M. Leisenring, ScD, Cancer Prevention and Clinical Statistics, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, D5-360, PO Box 19024, Seattle, WA 98109; e-mail: wleisenr{at}fhcrc.org.

The Childhood Cancer Survivor Study (CCSS) is a comprehensive multicenter study designed to quantify and better understand the effects of pediatric cancer and its treatment on later health, including behavioral and sociodemographic outcomes. The CCSS investigators have published more than 100 articles in the scientific literature related to the study. As with any large cohort study, high standards for methodologic approaches are imperative for valid and generalizable results. In this article we describe methodological issues of study design, exposure assessment, outcome validation, and statistical analysis. Methods for handling missing data, intrafamily correlation, and competing risks analysis are addressed; each with particular relevance to pediatric cancer survivorship research. Our goal in this article is to provide a resource and reference for other researchers working in the area of long-term cancer survivorship.

Supported by National Institutes of Health-National Cancer Institute Grants No. U24CA55727 and 5R01CA104666.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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