Clinical trial NCT00872833: Assessment of Pain in People With Thalassemia Who Are Treated With Regular Blood Transfusions
Official title: Assessment of Pain in Transfusion Dependent Patients With Thalassemia During Transfusion Cycles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia
Keywords: Transfusion-Dependant Thalassemia
Pain
Mild Pain
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-03-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with transfusion-dependent thalassemia who receive care at sites funded by the Thalassemia Clinical Research Network and their satellites.

Brief summary: Thalassemia is an inherited blood disorder that can result in mild to severe anemia. Regular blood transfusions, which refresh the healthy red blood cell supply, are one treatment for thalassemia. People with thalassemia often experience pain, but the exact source of pain remains unknown. This study will examine how pain varies during the blood transfusion cycle in people with thalassemia who are 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Report of Pain by Age Group
timeFrame: measured daily over the 3 transfusion cycles
Secondary outcomes:
measure: Report of Pain by Length of the Transfusion Cycle
timeFrame: measured daily over the 3 transfusion cycles
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Oakland
country: United States
facility: Children's Hospital Research Center Oakland
state: California
city: Stanford
country: United States
facility: Stanford University - School of Medicine
state: California
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Children's Memorial Hospital - Chicago
state: Illinois
city: New York
country: United States
facility: Weill Medical College of Cornell
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
Study officials:
affiliation: Children's Hospital and Research Institute Oakland
name: Dru Foote, NP
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Healthcare of Atlanta
name: Jeanne Boudreaux, MD
role: STUDY_CHAIR
affiliation: Children's Hospital Los Angeles
name: Thomas Coates, MD
role: STUDY_CHAIR
affiliation: UCSF Benioff Children's Hospital Oakland
name: Elliott Vichinsky, MD
role: STUDY_CHAIR
affiliation: Stanford University
name: Michael Jeng, MD
role: STUDY_CHAIR
affiliation: Children's Hospital of Philadelphia
name: Janet Kwiatkowski, MD
role: STUDY_CHAIR
affiliation: University Health Network - Toronto General Hospital
name: Nancy Olivieri, MD
role: STUDY_CHAIR
affiliation: Weill Medical College of Cornell
name: Patricia J. Giardina, MD
role: STUDY_CHAIR
affiliation: Baylor College of Medicine
name: Brigitta Mueller, MD
role: STUDY_CHAIR
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Alexis A. Thompson, MD, MPH
role: STUDY_CHAIR
References: