NCT03229837Completed
Validation Study of Pediatric Patient-Reported Outcomes
Pediatric Patient-Reported Outcomes (PEPR) for Childhood Cancer Survivors: Clinical Validity Study
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 303 (actual)
- First submitted
- 7 Jul 2017
- Start date
- 1 Aug 2017
- Primary completion date
- 22 Apr 2023
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT03229837
What you commit to
- Study type: Observational
- Participants enrolled: 303
- From 1 Aug 2017 to the primary completion date, 22 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cancer-related or unrelated (e.g., genetic disorders) neurocognitive injuries that requires parents/proxies to complete the survey \[e.g. intelligence quotient (IQ) \<70\];
Other
- Inability to read and speak English; or
- Parent doesn't agree to participate in the parent part of the study.
- 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.
Who the study is looking for
- 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.
- 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.
Age in the registry: 8 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.