Assessment of Pain in People With Thalassemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00872339
First received: March 30, 2009
Last updated: April 24, 2013
Last verified: April 2013

March 30, 2009
April 24, 2013
March 2009
June 2010   (final data collection date for primary outcome measure)
Prevalence of pain in participants with transfusion and non-transfusion dependent thalassemia [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00872339 on ClinicalTrials.gov Archive Site
  • Common sites of pain by age, gender, and diagnosis [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
  • Pain severity and influence of age, gender, or diagnosis [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
  • Impact of pain on functioning and well-being [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
  • Effectiveness of treatment and medication over time [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
  • Correlate the Brief Pain Inventory (BPI) and Adolescent Pediatric Pain Tool (APPT) in the adolescent population [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assessment of Pain in People With Thalassemia
Assessment of Pain Survey Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Thalassemia patients who receive regular blood transfusions and those who do not receive regular blood transfusions.

Thalassemia
Not Provided
  • 1
    People with transfusion-dependant thalassemia.
  • 2
    People with non-transfusion-dependant thalassemia.
  • 3
    Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
December 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
12 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00872339
639, U01HL065238
Yes
New England Research Institutes
New England Research Institutes
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jeanne Boudreeaux, MD Children's Healthcare of Atlanta
Principal Investigator: Ellis Neufeld, MD Children's Hospital Boston
Principal Investigator: Alexis Thompson, MD Children's Memorial Hospital of Chicago
Principal Investigator: Brigitta Mueller, MD Baylor College of Medicine at Houston
Study Chair: Dru Foote, RN, NP Children's Hospital and Research Institute of Oakland
Principal Investigator: Patricia Giardina, MD Weill Medical College of Cornell
Principal Investigator: Janet Kwiatkowski, MD Children's Hospital of Philadelphia
Principal Investigator: Nancy Olivieri, MD Toronto General Hospital
New England Research Institutes
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP