Validating Pain Scales in Children and Young Adults
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|ClinicalTrials.gov Identifier: NCT01639950|
Recruitment Status : Recruiting
First Posted : July 13, 2012
Last Update Posted : April 11, 2019
- 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.
- To study the effectiveness of pain rating scales given to children and young adults with cancer and related genetic conditions.
- 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.
- 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 or disease|
|Sickle Cell Disease Solid Tumor Leukemia Neurofibromatosis|
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.
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).
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||267 participants|
|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|
|Actual Study Start Date :||July 12, 2012|
Adults Group 1
Adult patients with neurofibromatosis 1 (NF1), genetic tumor predisposition syndromes (GTPS), malignant solid tumor, or leukemia
Adults Group 2
Adults with sickle cell disease (SCD)- closed
Children with neurofibromatosis 1 (NF1), genetic tumor predisposition syndromes (GTPS), malignant solid tumor, or leukemia. -closed
Parents of children with neurofibromatosis 1 (NF1), genetic tumor predisposition syndromes (GTPS), malignant solid tumor, or leukemia. - closed
- Feasability [ Time Frame: 1 time ]To validate the Pain Interference Index and the Pain Rating Scale by comparison with previously validated measures
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639950
|Contact: Staci M Peron, Ph.D.||(240) firstname.lastname@example.org|
|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|
|Principal Investigator:||Staci M Peron, Ph.D.||National Cancer Institute (NCI)|