Status:
ACTIVE_NOT_RECRUITING
Patient-Reported Outcome Version of the Common Criteria for Adverse Events
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Survivorship
Cancer
Eligibility:
All Genders
16+ years
Brief Summary
Childhood cancer survivors are vulnerable to treatment-related late effects, including physical and psychosocial morbidities, subsequent malignancies, and premature death. Symptom assessment provides ...
Detailed 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 meani...
Eligibility Criteria
Inclusion
- \> 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
- 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
Key Trial Info
Start Date :
December 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
837 Patients enrolled
Trial Details
Trial ID
NCT04050072
Start Date
December 16 2019
End Date
July 1 2027
Last Update
October 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105