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NCT03229837 · ClinicalTrials.gov registry record
Validation Study of Pediatric Patient-Reported Outcomes
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 303
- Enrollment target
NCT03229837: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT03229837 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 303 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03229837 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 303 participants
- Enrollment target
Study 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 of life. Although some patient-reported outcome (PRO) tools are available for survivors of childhood cancer younger than 18 years old, very few studies have been designed to evaluate longitudinal measurement properties of these PRO tools. In this study the investigators propose to recruit participants from a cohort of diverse childhood cancer survivors who were treated at St. Jude Children's Research Hospital (St. Jude) to improve assessment tools for PROs and health-related quality of life (HRQOL). The purpose of this study is to measure the link between Patient Reported Outcome Measurement Information System (PROMIS) and clinical assessments of childhood cancer survivors over time. PROMIS is a questionnaire that measures patient-reported outcomes in adults and children. The study plans to enroll 300 children. Surveys will be completed by the children and their parents/legal guardians (a total of 600 surveys). PRIMARY OBJECTIVES: 1. To evaluate the longitudinal construct validity of the PROMIS Pediatric measures for childhood cancer survivors by testing the association of change in PROMIS PRO scores and the change in health status measured by objective clinical assessment. Age at baseline and sex will be included in the analysis. 2. To establish clinically meaningful classifications of the PROMIS Pediatric measures for childhood cancer survivors by referring PROMIS PRO scores to health status measured by clinical assessment. Age at baseline and sex will be included in the analysis. 3. To estimate the minimally important differences (MIDs) of the PROMIS Pediatric measures by referring to the change of health status evaluated by anchor-based anchors and patient-based anchors for childhood cancer survivors. Age at baseline and sex will be included in the analysis.
Primary Outcome
The change of patient-reported outcome (PRO) between time points will be calculated.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2025-06-30 |
What the finished NCT03229837 record still lists
NCT03229837 is an observational study that tracks outcomes without assigning an intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03229837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03229837 about?
NCT03229837 is a clinical study titled "Validation Study of Pediatric Patient-Reported Outcomes". 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 of life. Although some patient-reported outcome (PRO) tools are available for survivors of childhood...
What is the current status of trial NCT03229837?
This trial is currently completed. The enrollment target is 303 participants. The study started on 2017-08-01. Estimated completion is 2025-06-30.
Who is sponsoring clinical trial NCT03229837?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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