Patient-Reported Outcome Version of the Common Criteria for Adverse Events

Running, not enrolling

Conditions studied: Survivorship, Cancer

In brief

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

Key facts

Study ID

NCT04050072

Run by

St. Jude Children's Research Hospital

People needed

837

Starts

2019-12-16

Expected to finish

2027-07-01

Last updated by the study team

2026-06-17

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• > 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.

You may not qualify if…

• 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

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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