Validating Pain Scales in Children and Young Adults
|First Received Date ICMJE||July 11, 2012|
|Last Updated Date||February 19, 2014|
|Start Date ICMJE||June 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01639950 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Validating Pain Scales in Children and Young Adults|
|Official Title ICMJE||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|
- 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.
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 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.
Eligible pediatric participants must:
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||267|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
ELIGIBILITY CRITERIA FOR PARENTS:
ELIGIBILITY CRITERIA FOR PATIENTS WITH SICKLE CELL DISEASE (SCD)
|Ages||6 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01639950|
|Other Study ID Numbers ICMJE||120160, 12-C-0160|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP