Working... Menu

Validating Pain Scales in Children and Young Adults

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. Identifier: NCT01639950
Recruitment Status : Recruiting
First Posted : July 13, 2012
Last Update Posted : April 11, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- 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

Detailed Description:


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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 267 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. Feasability [ Time Frame: 1 time ]
    To validate the Pain Interference Index and the Pain Rating Scale by comparison with previously validated measures

Secondary Outcome Measures :
  1. Validation [ Time Frame: 1 month ]
    To establish the reliability (internal consistency and inter-rater) of the PII and PRS

  2. Feasability [ Time Frame: 1 time ]
    To establish normative data for the PII and PRS.

  3. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The Pediatric Oncology Branch (POB) has active protocols currently accruing patients with NF1, leukemia, and solid tumors. POB has an active clinical trials program for NF1 consisting of both natural history and treatment protocols for PNs and MPNST's, which draws patients from a national referral base. In addition, POB investigators coordinate all phase 1 COG studies for the POB participation, which often targets lymphoma program have active clinical trials. Subjects will be recruited from these referral bases and the principal investigators from the relevant POB primary protocols have indicated their support for this project and willingness to allow their patients to participate.@@@As of Amendment E, patients with SCD are no longer eligible for enrollment.
  • 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.


  • Inability to read or understand English, as the purpose of this study is to validate the English versions of these tools.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01639950

Layout table for location contacts
Contact: Staci M Peron, Ph.D. (240) 760-6025

Layout table for location information
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
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Staci M Peron, Ph.D. National Cancer Institute (NCI)

Additional Information:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI) Identifier: NCT01639950     History of Changes
Other Study ID Numbers: 120160
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: November 21, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Survey Scale
Pain Severity

Additional relevant MeSH terms:
Layout table for MeSH terms
Neurofibromatosis 1
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms