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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-C-0160

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Sickle Cell Disease;
Solid Tumor;
Leukemia;
Neurofibromatosis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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Eligibility

IINCLUSION CRITERIA:

-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

EXCLUSION CRITERIA:

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.


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Citations:

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):1608-20. doi: 10.1016/j.pain.2011.02.052. Epub 2011 Apr 1.

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.

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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Staci M. Peron, Ph.D.
National Cancer Institute (NCI)
NIHBC 82 - RA BLOCH INTERNATIONAL CANCER CENTER BG RM 107
9030 OLD GEORGETOWN RD
BETHESDA MD 20892
(240) 760-6025
martins@mail.nih.gov

Staci M. Peron, Ph.D.
National Cancer Institute (NCI)
NIHBC 82 - RA BLOCH INTERNATIONAL CANCER CENTER BG RM 107
9030 OLD GEORGETOWN RD
BETHESDA MD 20892
(240) 760-6025
martins@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01639950

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