Validating Pain Scales in Children and Young Adults

NCT01639950 | Completed

• 2 other identifiers: 12016012-C-0160
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Solid Tumor; Leukemia; Neurofibromatosis

Keywords

Self-Report; Survey Scale; Validate; Pain Severity; Reliability; Natural History

Outcome Measures

Primary Outcomes (1)

• Feasability

  To validate the Pain Interference Index and the Pain Rating Scale by comparison with previously validated measures

  One time

Secondary Outcomes (3)

• Validation

  One month

• Feasability

  One time

• Feasability

  One time

Study Arms (4)

Adults Group 1

Adults patients with cancer or neurofibromatosis 1 (NF1)

Adults Group 2

Adults with sickle cell disease (SCD)

Children

Children with with neurofibromatosis 1 (NF1), genetic tumor predisposition syndromes (GTPS), malignant solid tumor, or leukemia. -closed

Parents

Parents of children with with neurofibromatosis 1 (NF1), genetic tumor predisposition syndromes (GTPS), malignant solid tumor, or leukemia. -closed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children, adolescents, and young adults ages 6 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)

You may qualify if:

• Participants must have a cytologically confirmed cancer, SCD, or meet the diagnostic criteria for NF1 documented in the medical record according to the primary treatment or natural history protocol. Participants must be at least one month post-diagnosis.
• Age \>= 18
• Participants 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.
• Ability to read and/or understand English

You may not qualify if:

• Participants may be excluded from this study if in the judgment of the Principal or Associate Investigator, the subject is too ill, or subject s cognitive ability would compromise their ability to participate in study related procedures.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Fayers PM, Hjermstad MJ, Klepstad P, Loge JH, Caraceni A, Hanks GW, Borchgrevink P, Kaasa S; European Palliative Care Research Collaborative (EPCRC). The dimensionality of pain: palliative care and chronic pain patients differ in their reports of pain intensity and pain interference. Pain. 2011 Jul;152(7):1608-1620. doi: 10.1016/j.pain.2011.02.052. Epub 2011 Apr 1.

  PMID: 21458921 BACKGROUND

• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.

  PMID: 21621130 BACKGROUND

• Engel JM, Jensen MP, Ciol MA, Bolen GM. The development and preliminary validation of the pediatric survey of pain attitudes. Am J Phys Med Rehabil. 2012 Feb;91(2):114-21. doi: 10.1097/PHM.0b013e318238a074.

  PMID: 22019973 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Anemia, Sickle Cell; Leukemia; Neurofibromatoses; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms by Histologic Type; Neoplasms; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Staci M Peron, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 13, 2012
• Study Start: August 6, 2012
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)