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

Assessment of Pain in Transfusion Dependent Patients With Thalassemia During Transfusion Cycles

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.

Study Overview

• Status: Completed
• Conditions: 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. 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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network - Toronto General Hospital
• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
    • Oakland, California, United States, 94609
      • Children's Hospital Research Center Oakland
    • Stanford, California, United States, 94305
      • Stanford University - School of Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Healthcare of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Children's Memorial Hospital - Chicago
  • New York
    • New York, New York, United States, 10065
      • Weill Medical College of Cornell
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
age 18-29; People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
age 30+; People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Report of Pain by Age Group	Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.	measured daily over the 3 transfusion cycles

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Report of Pain by Length of the Transfusion Cycle	Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.	measured daily over the 3 transfusion cycles

Collaborators and Investigators

• Sponsor: HealthCore-NERI
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Dru Foote, NP, Children's Hospital and Research Institute Oakland; Study Chair: Jeanne Boudreaux, MD, Children's Healthcare of Atlanta; Study Chair: Thomas Coates, MD, Children's Hospital Los Angeles; Study Chair: Elliott Vichinsky, MD, UCSF Benioff Children's Hospital Oakland; Study Chair: Michael Jeng, MD, Stanford University; Study Chair: Nancy Olivieri, MD, University Health Network - Toronto General Hospital; Study Chair: Patricia J. Giardina, MD, Weill Medical College of Cornell; Study Chair: Brigitta Mueller, MD, Baylor College of Medicine; Study Chair: Alexis A. Thompson, MD, MPH, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: March 30, 2009
• First Submitted That Met QC Criteria: March 30, 2009
• First Posted (ESTIMATE): March 31, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 7, 2015
• Last Update Submitted That Met QC Criteria: October 5, 2015
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Pain; Transfusion-Dependant Thalassemia; Mild Pain
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Thalassemia
• Other Study ID Numbers: 640; U01HL065238 (U.S. NIH Grant/Contract)