Evaluation of the Literacy Demand and Racial/Ethnic Influences for Self-Reported Symptomatic Adverse Events during Childhood Cancer Therapy

Background
Over 60% of children diagnosed with cancer will participate in a clinical trial; the great majority of these children will experience multiple treatment-related adverse events. The Federal Government mandates for safety monitoring that all trials report adverse events (AEs); defined by the National Cancer Institute (NCI) as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment.

The standard practice in oncology trials is for the clinician to grade all AEs using the NCI's Common Terminology Criteria for Adverse Events (CTCAE). Multiple studies in cancer populations found that clinicians underreport the number and severity of symptoms compared to what patients report. More than a third of the 790 AEs on the CTCAE have some subjective aspect to its identification, requiring patient-report to assure accuracy of the AE documentation.

Project Goal
Given the known toxicity of cancer treatments on children's lives, the child's perspectives in grading subjective AEs must be integrated into AE reporting. Without including the child's AE reports, the risk/benefit ratio of cancer treatments will not be accurately established.

This 18 month study proposes to further expand the validation testing of a newly developed pediatric patient-reported outcome measure of the CTCAE (PRO-CTCAE) which aims to capture the child's subjective experience of AEs. This study has a primary aim of conducting and evaluating literacy assessments in conjunction with cognitive interviews in children 7 to 20 years of age and their caregiver-proxies to solicit and analyze the PRO-CTCAE measures in relationship to reading level and race/ethnicity.