Validating Pain Scales in Children and Young Adults

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 18 to 34
years with cancer, neurofibromatosis 1 (NF1), or other genetic tumor predisposition syndromes
(GTPS), and their parents, and in adults with cancer, NF1, GTPS, or Sickle Cell Disease
(SCD).

ELIGIBILITY:

Eligible participants must:

- Have a diagnosis of NF1, GTPS, leukemia, or malignant solid tumor (including sarcoma,
neuroblastoma or melanoma). Be 18- 34 years of age, and enrolled on an NCI clinical trial or
natural history study.

DESIGN:

Eighty-four patients with solid tumor, NF1 or leukemia ages 8 to 34 and up to 108 parents of
these patients ages 8 to 25, and 69 patients with SCD 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 (if applicable) and medical
(diagnosis, date of diagnosis, pain medication) data will be collected from review of the
patients medical record. Parents of participating patients will be asked to complete the
Parent version of the PII and the Parent PRS. Correlations between patient and parent
questionnaire results for patients with solid tumor, NF1, GTPS, and leukemia will be
correlated to establish validity and reliability of the PII and PRS. Also, results from
mother and father reports will be correlated to assess inter-rater reliability. Data on up to
12 patients ages 6 and 7 years will be collected to determine the feasibility of the forms in
this younger age group. A subset of evaluable patients with SCD (n=28) will be asked to
repeat the PII after approximately 1 month to assess test-retest reliability in this tool.

- 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 18 and less than or equal to 34 years of age.

- Patients who complete the pain interference measure (the Pain Interference Index PII)
and the pain severity tool (Pain Rating Scale PRS) once but who miss their Time 2
evaluation, are eligible to enroll a second time to complete the measures again in
order to participate in the test-retest reliability assessment.

EXCLUSION CRITERIA:

- Inability to read or understand English, as the purpose of this study is to validate
the English versions of these tools.