Status:
COMPLETED
Validation Study of Pediatric Patient-Reported Outcomes
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Children's Hospital of Philadelphia
Conditions:
Tumor
Malignancy
Eligibility:
All Genders
8-18 years
Brief Summary
Survivors of childhood cancer often suffer treatment-related toxicities, including chronic health conditions, high symptom burden and emotional distress, and decremented functional status and quality ...
Detailed Description
A longitudinal framework was designed to collect data from childhood cancer survivors (8-18.9 years of age) and parents of participating cancer survivors (i.e., dyads) when they visit the After Comple...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Childhood Survivors:
- St. Jude childhood cancer survivors who have consented to SJLIFE;
- Age at assessment: 8-18.9 years at T1 (toward 20.9 years at T3);
- 2 years off therapy and \> 5 years since diagnosis; and
- Agrees to complete three annual assessments during routinely scheduled ACT clinic appointments.
- Exclusion Criteria for Childhood Survivors:
- Cancer-related or unrelated (e.g., genetic disorders) neurocognitive injuries that requires parents/proxies to complete the survey \[e.g. intelligence quotient (IQ) \<70\];
- Inability to read and speak English; or
- Parent doesn't agree to participate in the parent part of the study.
- Inclusion Criteria for Parents/Legal Guardians:
- Parent/legal guardian of St. Jude childhood cancer survivor aged 8-18.9 who is eligible to participate and has agreed to do so;
- Participant is not developmentally delayed, intellectually disabled or non-communicative; and
- Participant speaks and understands the English language.
- Exclusion Criteria for Parents/Legal Guardians:
- Developmentally delayed, intellectually disabled or non-communicative;
- Unable to speak or understand the English language; and
- Child doesn't agree to participate in child part of the study.
Exclusion
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT03229837
Start Date
August 1 2017
End Date
June 30 2025
Last Update
August 27 2025
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105