Patient-Reported Outcome Version of the Common Criteria for Adverse Events
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About
Childhood cancer survivors are vulnerable to treatment-related late effects, including physical and psychosocial morbidities, subsequent malignancies, and premature death. Symptom assessment provides a unique insight into survivorship care since symptoms not only indicate the manifestation for the occurrence of chronic health conditions, but also impact quality of life and survival. The National Cancer Institute (NCI) has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to assess symptomatic adverse events (AEs) for adult-onset cancer patients who are receiving cancer therapies. However, content-appropriate and clinically validated symptom assessment tools for adult survivors of childhood cancer are not available.
Primary Object 1: Establish content validity for the PRO-CTCAE-SCC
Primary Objective 1A: Conduct a symptom selection process through qualitative research to identify symptomatic AEs for adult survivors of childhood cancer
Primary Objective 1B: Create symptomatic AE items for adult survivors of childhood cancer based on the prevalence and clinical importance ratings on the items
Primary Objective 2: Validate the PRO-CTCAE-SCC using psychometric methods and objective clinical parameters
Primary Objective 2A: Test dimensionality for the PRO-CTCAE-SCC
Primary Objective 2B: Test clinical validity for the PRO-CTCAE-SCC
Primary Objective 2C: Test responsiveness to change for the PRO-CTCAE-SCC
Secondary Objective 1: Increase clinical usefulness of the PRO-CTCAE-SCC
Secondary Objective 2: Establish meaningful cut-points and minimally important differences (MIDs) on symptom burden scores for clinical decision-making
Full description
We propose to adapt an existing symptomatic adverse event tool, the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), to be content appropriate and clinically meaningful for adult survivors of childhood cancer using two well-established childhood cancer survivor cohorts. Psychometric methodologies will be used to validate this tool by incorporating objective clinical anchors collected from medical evaluations. Our symptomatic AE tool has the potential to augment the Children Oncology Group Survivorship Care Guidelines by implementing risk-based symptom screening to track and anticipate adverse health events.
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Inclusion criteria
- > or equal to16 years of age at the time of enrollment
- > or equal to 5 years from initial diagnosis of pediatric cancer/malignancy (for CCSS and SJLIFE survivors only) and currently not receiving cancer therapies.
Exclusion criteria
- Have a known severe neurocognitive impairment, which requires proxies/parents to complete the survey
- Have < third grade reading level or are not able to communicate in English
- Unable to use and/or access internet or computer/tablet (for survey only)
- Unable to communicate and read in English
Trial design
765 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
I-Chang Huang, PhD
Data sourced from clinicaltrials.gov
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