Validating Pain Scales in Children and Young Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01639950
First received: July 11, 2012
Last updated: June 17, 2014
Last verified: February 2014
  Purpose

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.

Condition
Solid Tumor
Leukemia
Neurofibromatosis

Study Type: Observational
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 198
Study Start Date: June 2012
Detailed Description:

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, and in adults with cancer, NF1, GTPS, or Sickle Cell Disease (SCD). 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) and be 6 25 years of age, and enrolled on an NCI clinical trial or natural history study, with a parent or guardian willing to complete the corresponding parent measures

    OR

  2. Have a diagnosis of cancer, NF1, GTPS, or Sickle Cell Disease (SCD), 18 years of age or older, seen at the NIH.

DESIGN:

Fifty-four patients with solid tumor, NF1 or leukemia ages 8 to 25 and up to 108 parents of these patients, 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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • ELIGIBILITY CRITERIA FOR PATIENTS WITH SOLID TUMORS, NF1, GTPS OR LEUKEMIA:

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.
  • 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.

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.

ELIGIBILITY CRITERIA FOR PATIENTS WITH SICKLE CELL DISEASE (SCD)

INCLUSION CRITERIA:

  • Patients must be diagnosed with SCD
  • Age greater than or equal to 18 years of age
  • Able to read or understand English, as the purpose of this study is to validate the English versions of these tools.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639950

Contacts
Contact: Staci M Peron, Ph.D. (301) 435-3964 martins@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Staci M Peron, Ph.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01639950     History of Changes
Other Study ID Numbers: 120160, 12-C-0160
Study First Received: July 11, 2012
Last Updated: June 17, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Self-Report
Survey Scale
Validate
Pain Severity
Reliability

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibromatosis 1
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplastic Syndromes, Hereditary
Nerve Sheath Neoplasms
Nervous System Diseases
Neurocutaneous Syndromes
Neurodegenerative Diseases
Neurofibroma
Neuromuscular Diseases
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on October 23, 2014