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Assessment of Pain in People With Thalassemia (Pain)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00872339
Recruitment Status : Completed
First Posted : March 31, 2009
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
HealthCore-NERI

Study Description
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Brief Summary:
Thalassemia is an inherited blood disorder that can result in mild to severe anemia. People with thalassemia often experience pain, but the exact sources and prevalence of pain remain unknown. This study will examine the prevalence and severity of pain in people with thalassemia who are treated with regular blood transfusions and people with thalassemia who are not treated with regular blood transfusions.

Condition or disease
Thalassemia

Detailed Description:

Thalassemia is an inherited blood disorder in which the body makes an abnormal form of hemoglobin-the protein in red blood cells that carries oxygen. People with thalassemia often experience fatigue, shortness of breath, and pain. Recent medical advances in treating people with thalassemia who receive regular blood transfusions-a standard procedure that refreshes the healthy red blood supply-have resulted in increased life spans for these people. However, with the extended life spans have come additional issues, including pain. There have been no previous research studies that have examined pain levels in people with thalassemia, and as a result, the sources and prevalence of pain remain unknown. The purpose of this study is to assess the prevalence and severity of pain, common pain sites, and the impact of pain on functioning and well-being in people with thalassemia who receive regular blood transfusions and people with thalassemia who do not receive regular blood transfusions.

This study will enroll people with transfusion-dependant thalassemia and people with non-transfusion-dependant thalassemia. At a baseline study visit, participants will complete a demographic questionnaire and a pain assessment questionnaire. At Months 3, 6, and 9, study researchers will telephone participants to go over the same pain assessment questionnaire again.

Study Design
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Study Type : Observational
Actual Enrollment : 252 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Pain in People With Thalassemia
Study Start Date : March 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Groups and Cohorts
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Group/Cohort
transfusion-dependant
People with transfusion-dependant thalassemia who received at least 8 transfusions in the past year.
non-transfusion-dependant
People with non-transfusion-dependant thalassemia who received no transfusions in the past year.
intermittently transfused
Intermittently transfused patients- individuals who received at least one but fewer than eight transfusions in the last year


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of Pain [ Time Frame: Measured at Month 9 ]

Secondary Outcome Measures :
  1. Common Sites of Pain [ Time Frame: Measured at Month 9 ]
  2. Pain Occurrence by Age [ Time Frame: Measured at Month 9 ]
  3. Impact of Pain on Functioning and Well-being [ Time Frame: Measured at Month 9 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Thalassemia patients who receive regular blood transfusions and those who do not receive regular blood transfusions.
Criteria

Inclusion Criteria:

  • Thalassemia, as documented by clinical diagnosis, including the following:

    1. B-thalassemia (intermedia or major)
    2. Hgb H disease
    3. Hgb H with non-deletional mutations (e.g., Hgb H Constant Spring)
    4. E-B-thalassemia
    5. Homozygous alpha thalassemia
    6. Other thalassemic conditions not explicitly excluded
    7. Thalassemia intermedia due to heterozygous B mutation with an alpha excess
  • Participants can be of any race, ethnicity, and either gender.

Exclusion Criteria:

  • Thalassemia trait (i.e., single recessive B gene mutation, 2 gene alpha mutation) and thalassemia Hgb S, C, or D compound heterozygotes
  • Unwillingness or inability to complete the Brief Pain Inventory (BPI) on a quarterly basis
  • Has had a successful bone marrow transplant
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00872339


Locations
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United States, California
Children's Hospital and Research Institute at Oakland
Oakland, California, United States, 94609
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
United States, Illinois
Children's Memorial Hospital of Chicago
Chicago, Illinois, United States, 60614
United States, Massachusetts
Children's Hospital of Boston
Boston, Massachusetts, United States, 02115
United States, New York
Weill Medical College
New York, New York, United States, 10065
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
HealthCore-NERI
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jeanne Boudreeaux, MD Children's Healthcare of Atlanta
Principal Investigator: Ellis Neufeld, MD Boston Children's Hospital
Principal Investigator: Alexis Thompson, MD Children's Memorial Hospital of Chicago
Principal Investigator: Brigitta Mueller, MD Baylor College of Medicine at Houston
Study Chair: Dru Foote, RN, NP Children's Hospital and Research Institute of Oakland
Principal Investigator: Patricia Giardina, MD Weill Medical College of Cornell
Principal Investigator: Janet Kwiatkowski, MD Children's Hospital of Philadelphia
Principal Investigator: Nancy Olivieri, MD Toronto General Hospital
More Information
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Publications of Results:

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Responsible Party: HealthCore-NERI
ClinicalTrials.gov Identifier: NCT00872339    
Other Study ID Numbers: 639
U01HL065238 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2009    Key Record Dates
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014
Last Verified: January 2014
Keywords provided by HealthCore-NERI:
Transfusion-Dependent Thalassemia
Non-Transfusion-Dependent Thalassemia
Additional relevant MeSH terms:
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Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn