Assessment of Pain in People With Thalassemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thalassemia
- Sponsor
- Carelon Research
- Enrollment
- 252
- Locations
- 8
- Primary Endpoint
- Prevalence of Pain
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Thalassemia, as documented by clinical diagnosis, including the following:
- •B-thalassemia (intermedia or major)
- •Hgb H disease
- •Hgb H with non-deletional mutations (e.g., Hgb H Constant Spring)
- •E-B-thalassemia
- •Homozygous alpha thalassemia
- •Other thalassemic conditions not explicitly excluded
- •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
Outcomes
Primary Outcomes
Prevalence of Pain
Time Frame: Measured at Month 9
Secondary Outcomes
- Pain Occurrence by Age(Measured at Month 9)
- Impact of Pain on Functioning and Well-being(Measured at Month 9)
- Common Sites of Pain(Measured at Month 9)