PEPR: Patient-Reported Outcomes in Childhood Cancer Survivors

Validation of Pediatric Patient-Reported Outcomes (PEPR) for Childhood Cancer Survivors

Category:

Quality of Life

Diseases Treated:

Cancer

Eligibility Overview:

This is a non-therapeutic clinical trial that is only open to St. Jude patients and their parents.

  • St. Jude childhood cancer survivors between 8 and 17 years old
  • Parents of St. Jude childhood cancer survivors
  1. Brief Summary

    Understanding the experiences of pediatric patients is crucial to assessing the timing and potential success of interventions. The National Institutes of Health (NIH) Patient-Reported Outcome Measurement Information System, or PROMIS®, has produced 20 pediatric patient-reported outcome instruments that have good reliability, validity and precision in general pediatric populations. However, there are few studies evaluating measurement properties of the PROMIS tools in chronic disease populations.

    This non-therapeutic trial is part of the NIH’s Pediatric Patient-Reported Outcomes in Chronic Diseases (PEPR) consortium study to review patient-reported outcomes across different disease groups in children. The prospective study focuses on St. Jude childhood cancer survivors from 8 to 17 years old.

    Primary Objective

    • Evaluate the content validity of the following six PROMIS pediatric item banks in St. Jude childhood cancer survivors:
      • Pain interference
      • Fatigue
      • Psychological stress experiences
      • Positive affect
      • Meaning and Purpose
      • Stigma

    Eligibility Criteria

    Inclusion criteria include:

    • St. Jude childhood cancer survivors between 8 and 17 years old
    • Speaks English
    • Parent or legal guardian of a St. Jude childhood cancer survivor between the ages of 8 and 17 years old

    Exclusion Criteria include:

    • Developmental delay, intellectual disability or communication challenge that prevents participant from completing an interview or card sort task

    Study Sites

    St. Jude Children’s Research Hospital and collaborating institutions in the U.S.
    Memphis, Tennessee

  2. About this study

    It is important for doctors to know how patients feel, the kinds of activities they are able to participate in and how happy they are with their health. Doctors can find this out by asking patients questions in a survey.

    One survey used by many doctors is called the Patient-Reported Outcome Measurement Information System, also known as PROMIS. The National Institutes of Health created the PROMIS in 2004 to help doctors learn how their patients are doing. The survey includes various types of health-related questions such as, “How tired do you feel?” and “Are you having any pain?” The answers to these questions can help doctors understand how treatment affects their patients. This understanding can help doctors plan treatments for future patients.

    Purpose of this clinical trial

    Researchers want to see how well this survey works in childhood cancer survivors at St. Jude. They want to know if the children understand the survey questions easily. Researchers also want to know how well the survey questions measure the children’s feelings

    Eligibility overview

    This is a non-therapeutic clinical trial that is only open to St. Jude patients and their parents.

    • St. Jude childhood cancer survivors between 8 and 17 years old
    • Parents of St. Jude childhood cancer survivors
  3. PEPR Quick View
    Sponsors National Institutes of Health
    Trial Start Date September 2016
    Estimated Enrollment 60 children and 45 parents
    Study Type Prospective
    Conditions Childhood cancer survivors
    Ages Children: Between 8 and 17 years old; parents: 18 years and older
    Principal investigators I-Chan Huang, PhD; Baker Justin, MD 
    Study Sites St. Jude Children’s Research Hospital and collaborating institutions in the U.S.
    For a consultation or to discuss PEPR

    St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

I-Chan Huang, PhD, and Justin Baker, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.