Validating Pain Scales in Children and Young Adults

Background:

- Assessing pain levels is important to improve treatments for different illnesses. Most pain rating scales are used to determine pain levels in adults. Pain is also a common symptom among children who have cancer. Those who have genetic conditions that may lead to cancer may also have pain symptoms. However, the pain scales used for adults have not been fully tested in children and young adults. As a result, they may not be as accurate. Researchers want to test pain rating scales in children and young adults who have cancer and genetic conditions that can lead to cancer.

Objectives:

- To study the effectiveness of pain rating scales given to children and young adults with cancer and related genetic conditions.

Eligibility:

• Children, adolescents, and young adults between 6 and 25 years of age who have cancer or other genetic conditions that can lead to cancer.
• Parents of participating children will also be eligible.

Design:

• Participants with cancer or related genetic conditions will fill out four questionnaires. These questionnaires will ask about pain levels and how much pain interferes with daily life.
• Parents will fill out two questionnaires about their child's pain levels and how much pain interferes with the child's life.
• Pain treatments will not be provided as part of this study.

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.

• Solid Tumor
• Leukemia
• Neurofibromatosis

• Averbuch M, Katzper M. Assessment of visual analog versus categorical scale for measurement of osteoarthritis pain. J Clin Pharmacol. 2004 Apr;44(4):368-72.
• Beyer JE, Denyes MJ, Villarruel AM. The creation, validation, and continuing development of the Oucher: a measure of pain intensity in children. J Pediatr Nurs. 1992 Oct;7(5):335-46.
• Beyer JE, Turner SB, Jones L, Young L, Onikul R, Bohaty B. The alternate forms reliability of the Oucher pain scale. Pain Manag Nurs. 2005 Mar;6(1):10-7.

• 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.