Assessment of Quality of Life in Thalassemic Patients at Assiut University Hospital: A Single-center Experience

Thalassemia Clinical Trial

Official title:

Assessment of Quality of Life in Thalassemic Patients at Assiut University Hospital: A Single-center Experience

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05790980
• Other study ID #: quality of life in thalassemia
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Reham Abdelraheem
• Phone: 01005558459
• Email: rehamabdelraheem128[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The thalassemias are a group of inherited hematologic disorders caused by defects in the synthesis of one or more of the hemoglobin chains [1]. Thalassemia are classified into the alpha (α) and (β) thalassemia, which contain deficits in (α) and (β) globin production respectively (α)thalassemia are caused by decreased production of alpha-globin chains from chromosome 16. There are 4 types of (α) thalassemia: thalassemia silent carrier thalassemia carrier . Hemoglobin H disease thalassemia major Beta-thalassemia are caused by point mutations or more rarely deletions in the β-globin gene on chromosome 11, leading to reduced (β+) or absent (β0) synthesis of the β chains of hemoglobin. Imbalances of globin chains cause hemolysis and impair erythropoiesis [4-7]. β-thalassemia can be classified into: Beta Thalassemia major, Beta Thalassemia intermedia, Beta Thalassemia minor Thalassemia is a chronic disease that presents a range of serious clinical and psychological challenges.

The effects of thalassemia on physical health can lead to physical deformity, growth retardation, and delayed puberty [9, 10]. Its impact on physical appearance, e.g., bone deformities and short stature, also contributes to a poor self-image [10, 11]. Severe complications such as heart failure, cardiac arrhythmia, liver disease, endocrine complications, and infections are common among thalassemia patients [8, 12].

Description:

The problems mentioned do not only affect patients' physical functioning but also their emotional functioning, social functioning and school functioning, leading to impaired Health-related quality of life (HRQOL) of the patients [13]. QOL is a phrase used to refer to an individual's total wellbeing. This includes all emotional, social, and physical aspects of the individual's life. Health-related quality of life (HRQOL) Moreover, the term health-related quality of life (HRQOL) is often described as: "A term referring to the health aspects of quality of life, generally considered to reflect the impact of disease and treatment on disability and daily functioning; it has also been considered to reflect the impact of perceived health on an individual's ability to live a fulfilling life.[18-19] HRQOL is comprised of a number of dimensions of influence. Seven are commonly agreed upon

1. Physical well-being: the experience of physical symptoms such as pain, dyspnea, or nausea.

2. Functional well-being: the ability to participate in normal daily activities such as work and leisure pursuits.

3. Emotional well-being: this is comprised of both positive affective states (e.g. happiness, peace of mind) and negative affective states (e.g. sadness, anxiety).

4. Family well-being: the ability to maintain family relationships and communication.

5. Social functioning: the ability to participate and enjoy social roles and activities.[20]

6. Treatment satisfaction: including financial concerns.

7. Sexuality/intimacy: including concerns about body image.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: June 1, 2025
• Est. primary completion date: March 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Thalassemic patients more than 18 years old.

Exclusion Criteria:

• Thalassemic patients less than 18 years old. Patients with other causes of aneamia. Patients with other causes of liver cirrhosis. Patients with other causes of renal diseases.

Related Conditions & MeSH terms

• Thalassemia

Intervention

Device:
• Abdominal ultrasound
Abdominal US to exclude splenomegaly and hepatomegaly or liver cirrhosis Echocardiology to show cardiac dysfunction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Galanello R, Cao A. Gene test review. Alpha-thalassemia. Genet Med. 2011 Feb;13(2):83-8. doi: 10.1097/GIM.0b013e3181fcb468. No abstract available. — View Citation

Khodashenas M, Mardi P, Taherzadeh-Ghahfarokhi N, Tavakoli-Far B, Jamee M, Ghodrati N. Quality of Life and Related Paraclinical Factors in Iranian Patients with Transfusion-Dependent Thalassemia. J Environ Public Health. 2021 Aug 18;2021:2849163. doi: 10.1155/2021/2849163. eCollection 2021. — View Citation

Shafique F, Ali S, Almansouri T, Van Eeden F, Shafi N, Khalid M, Khawaja S, Andleeb S, Hassan MU. Thalassemia, a human blood disorder. Braz J Biol. 2021 Sep 3;83:e246062. doi: 10.1590/1519-6984.246062. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assisment of Quality of life in thalassemic patient	assess the health-related quality of life among thalassemic patients attending Clinical hematology unit, Assiut University Hospital in a questionnaire manner	baseline