Assessment of Pain in People With Thalassemia Who Are Treated With Regular Blood Transfusions

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. There have been no previous research
studies that have fully examined pain levels in people with thalassemia, and as a result,
the sources of pain remain unknown. This study is a substudy of the Assessment of Pain
study, which is a Thalassemia Clinical Research Network (TCRN) study that is examining the
prevalence and severity of pain in people with transfusion-dependent thalassemia and
non-transfusion-dependant thalassemia. This study will enroll a subset of participants from
the Assessment of Pain study who have transfusion-dependant thalassemia. The purpose of this
study is to examine whether pain varies during the blood transfusion cycle and whether the
length of the transfusion cycle affects pain levels in people with transfusion-dependent
thalassemia.

Participants will complete daily questionnaires through an automated telephone system to
assess pain levels during three blood transfusion cycles. Each transfusion cycle will last
between 2 to 4 weeks, depending on the individual needs of the participant, and the cycles
will be separated by at least 3 months but no more than 4 months. Prior to each transfusion
cycle, study researchers will review participants' medical records for certain blood level
measurements.

Inclusion Criteria:

- Participating in the Thalassemia Clinical Research Network Assessment of Pain study

- Has a transfusion dependence of at least eight transfusions per year

- Diagnosis of beta thalassemia or E-beta-thalassemia

- Experiences at least "mild" pain in the 1 month before study entry, as measured by
the response to the Brief Pain Inventory (BPI) question #6 from the Assessment of
Pain study

Exclusion Criteria:

- Unwillingness or inability to complete the Brief Pain Inventory Short Form (BPI-SF)
on a daily basis