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Spots Global Cancer Trial Database for Validating Pain Scales in Children and Young Adults

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Trial Identification

Brief Title: Validating Pain Scales in Children and Young Adults

Official Title: Validation of the English Version of the Pain Interference Index and the Pain Rating Scale in Children, Adolescents, and Adults With Chronic Illness and Their Parents

Study ID: NCT01639950

Interventions

Study Description

Brief Summary: 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 adults with Sickle Cell Disease (SCD),cancer, and related genetic conditions. Eligibility: - Adults 18 and 34 years of age and older who have SCD, cancer, or other genetic conditions that can lead to cancer. Design: * Participants with SCD, 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. * Pain treatments will not be provided as part of this study.

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 the following populations: -Children, adolescents, and young adults ages 8 to 25 years with chronic pain related to cancer, Neurofibromas type 1 (NF1), genetic tumor predisposition syndromes (GTPS), a solid tumor (including but not limited to sarcoma, neuroblastoma, or melanoma), or leukemia and their parent(s) or guardians. (COMPLETED) Adults \> =18 years of age with cancer, NF1, Sickle Cell Disease (SCD) Eligibility: * \>= 18 years of age * Diagnosis of cancer, NF1, SCD * Enrolled on a clinical trial or natural history study at the NIH Clinical Center Design: * Eligible participants 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 - reviewed during a scheduled clinic visit for their primary protocol, over video conferencing, or while inpatient. * Demographic (gender and age, parent gender (if applicable) and medical (diagnosis, date of diagnosis, pain medication) data will be collected from review of the participants medical record. * A subset of evaluable participants with SCD will be asked to repeat the PII after approximately 1 month to assess test-retest reliability in this tool. * Parents of pediatric participants were asked to complete the Parent version of the PII and the Parent PRS. Correlations between patient participant and parent participant questionnaire results for participants with solid tumor, NF1, GTPS, and leukemia will be correlated to establish validity and reliability of the PII and PRS. (COMPLETE) * Also, results from mother and father reports will be correlated to assess inter-rater reliability. (COMPLETE) -Data from 12 participants ages 6 and 7 years was collected to determine the feasibility of the forms in this younger age group. (COMPLETE)

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Contact Details

Name: Staci M Peron, Ph.D.

Affiliation: National Cancer Institute (NCI)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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