Assessment of Pain in People With Thalassemia

NCT ID: NCT00872339

Last Updated: 2014-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 252 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-12-31

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.

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.

Conditions

Thalassemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

transfusion-dependant

People with transfusion-dependant thalassemia who received at least 8 transfusions in the past year.

No interventions assigned to this group

non-transfusion-dependant

People with non-transfusion-dependant thalassemia who received no transfusions in the past year.

No interventions assigned to this group

intermittently transfused

Intermittently transfused patients- individuals who received at least one but fewer than eight transfusions in the last year

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Carelon Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeanne Boudreeaux, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Healthcare of Atlanta

Ellis Neufeld, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Alexis Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Memorial Hospital of Chicago

Brigitta Mueller, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine at Houston

Dru Foote, RN, NP

Role: STUDY_CHAIR

Children's Hospital and Research Institute of Oakland

Patricia Giardina, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell

Janet Kwiatkowski, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Nancy Olivieri, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital

Locations

Children's Hospital and Research Institute at Oakland

Oakland, California, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Children's Memorial Hospital of Chicago

Chicago, Illinois, United States

Children's Hospital of Boston

Boston, Massachusetts, United States

Weill Medical College

New York, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Toronto General Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

Haines D, Martin M, Carson S, Oliveros O, Green S, Coates T, Eile J, Schilling L, Dinu B, Mendoza T, Gerstenberger E, Trachtenberg F, Vichinsky E; Thalassemia Clinical Research Network. Pain in thalassaemia: the effects of age on pain frequency and severity. Br J Haematol. 2013 Mar;160(5):680-7. doi: 10.1111/bjh.12177. Epub 2012 Dec 30.

Reference Type: RESULT

PMID: 23278768 (View on PubMed)

Other Identifiers

U01HL065238

Identifier Type: NIH

Identifier Source: secondary_id

View Link

639

Identifier Type: -

Identifier Source: org_study_id