Validation of the English Version of the Pain Interference Index and the Pain Rating Scale in Children, Adolescents, and Young Adults With Chronic Illness and Their Parents
6 Years
N/A
Both
Solid Tumor, Leukemia, Neurofibromatosis
Trial Information
Validation of the English Version of the Pain Interference Index and the Pain Rating Scale in Children, Adolescents, and Young Adults With Chronic Illness and Their Parents
Background:
Pain is a common symptom among children with a variety of medical illnesses. Currently, a
number of rating scales are used to assess pain interference and pain severity in adults.
However, relatively few measures assessing these variables have been validated for use with
children and adolescents, and existing tools have limitations.
Objectives:
The primary objective is to validate the self-report and parent versions of the Pain
Interference Index (PII) and the Pain Rating Scale (PRS) by comparison with previously
validated measures of pain interference (Modified Brief Pain Inventory) and pain severity
(Faces Pain Scale - Revised) in children, adolescents, and young adults ages 8 to 25 years
with cancer, neurofibromatosis 1 (NF1), or other genetic tumor predisposition syndromes
(GTPS), and their parents. Secondary objectives include collecting data on the reliability
of the PII and PRS, establishing normative data, and determining the feasibility of using
the PII and PRS with children ages 6 and 7 years.
Eligibility:
Eligible pediatric participants must:
1. Have a diagnosis of NF1, GTPS, leukemia, or malignant solid tumor (including sarcoma,
neuroblastoma or melanoma)
2. Be 6 - 25 years of age
3. Be enrolled on an NCI clinical trial or natural history study
4. Have a parent or guardian willing to complete the corresponding parent measures
Design:
Fifty-four patients ages 8 to 25 and up to 108 parents of these patients will be asked to
respond one time to the PII and the PRS, as well as the Modified Brief Pain Inventory and
Faces Pain Scale - Revised during a scheduled clinic visit for their primary NCI protocol,
or while inpatient. In addition, demographic (patient gender and age, parent gender) and
medical (diagnosis, date of diagnosis, pain medication) data will be collected from review
of the patients medical record.
Inclusion Criteria
- ELIGIBILITY CRITERIA FOR PATIENTS:
INCLUSION CRITERIA:
- Patients must have a cytologically confirmed malignant solid tumor (including but not
limited to sarcoma, neuroblastoma or melanoma) or leukemia, or meet the diagnostic
criteria for NF1 or other GTPS as documented in the medical record according to the
primary NCI protocol. Patients must be at least one month post-diagnosis.
- Age greater than or equal to 6 and less than or equal to 25 years of age.
- Willingness of a parent or guardian to complete the parent measures.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the
willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
- Inability to read or understand English, as the purpose of this study is to validate
the English versions of these tools.
ELIGIBILITY CRITERIA FOR PARENTS:
INCLUSION CRITERIA:
- Parents must have a child who is participating in this study.
- Ability of parent to understand and willingness to sign a written informed consent
document.
- Ability to read and understand English.
Type of Study:
Observational
Study Design:
N/A
Principal Investigator
Staci M Peron, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
120160
NCT ID:
NCT01639950
Start Date:
June 2012
Completion Date:
Related Keywords:
- Solid Tumor
- Leukemia
- Neurofibromatosis
- Self-Report
- Survey Scale
- Validate
- Pain Severity
- Reliability
- Leukemia
- Neurofibromatoses
- Neurofibromatosis 1
- Osteitis Fibrosa Cystica
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
