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Validation Study of Pediatric Patient-Reported Outcomes

NCT03229837 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 303

Last updated 2026-02-05

No results posted yet for this 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.

Conditions

  • Tumor
  • Malignancy

Sponsors & Collaborators

Principal Investigators

  • I-Chan Huang, PhD · St. Jude Children's Research Hospital

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2023-04-22
Completion
2025-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03229837 on ClinicalTrials.gov