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Validating Pain Scales in Children and Young Adults

This study is currently recruiting participants.
Verified May 26, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01639950
First Posted: July 13, 2012
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
July 11, 2012
July 13, 2012
December 14, 2017
June 21, 2012
Not Provided
Feasability [ Time Frame: 1 time ]
To validate the Pain Interference Index and the Pain Rating Scale by comparison with previously validated measures
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Complete list of historical versions of study NCT01639950 on ClinicalTrials.gov Archive Site
  • Validation [ Time Frame: 1 month ]
    To establish the reliability (internal consistency and inter-rater) of the PII and PRS
  • Feasability [ Time Frame: 1 time ]
    To establish normative data for the PII and PRS.
  • Feasability [ Time Frame: 1 time ]
    To gather preliminary data on the feasibility of using the PII and PRS with children ages 6 and 7 years
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Validating Pain Scales in Children and Young Adults
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:

- 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 18 and 34 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 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
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  • Sickle Cell Disease
  • Solid Tumor
  • Leukemia
  • Neurofibromatosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
267
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  • 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.
Sexes Eligible for Study: All
18 Years to 34 Years   (Adult)
Yes
Contact: Staci M Peron, Ph.D. (240) 760-6025 martins@mail.nih.gov
United States
 
 
NCT01639950
120160
12-C-0160
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National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Staci M Peron, Ph.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
May 26, 2017