Validation Study of Pediatric Patient-Reported Outcomes

NCT03229837 | Completed

• 2 other identifiers: PEPR IIU19AR069525
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

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 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. 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. 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. 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

Keywords

Construct validity; Minimally important differences; Patient-reported outcomes; Pediatric cancer survivors; PROMIS pediatric measures

Outcome Measures

Primary Outcomes (1)

• Change of PROs

  The change of patient-reported outcome (PRO) between time points will be calculated.

  From baseline through 3 years

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from a cohort of diverse childhood cancer survivors who were treatment at St. Jude and their parents/legal guardians.

You may qualify if:

• 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);
• years off therapy and \> 5 years since diagnosis; and
• Agrees to complete three annual assessments during routinely scheduled ACT clinic appointments.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Neoplasms

Study Officials

• I-Chan Huang, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 26, 2017
• Study Start: August 1, 2017
• Primary Completion: April 22, 2023
• Study Completion: June 30, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)