PEPR: Patient-Reported Outcomes in Childhood Cancer Survivors

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

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