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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03190499
Other study ID # ALL_AML
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date August 1, 2018

Study information

Verified date August 2018
Source Cumhuriyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Childhood cancers cover a wide range of diseases; leukemia, central nervous system cancers and lymphomas are the most common ones among them. During medical treatment children with cancer are at risk of neuromuscular and musculoskeletal complications such as reduced muscle strength, gross and fine motor performance impairment, decreased energy consumption. These neuromuscular and musculoskeletal complications can affect dynamic balance, endurance and quality of life of the children. Childhood cancers have negative effects on sleep. The aim of this study is to identify the status of sleep, fatigue, and quality of life in children with various types of cancer and to examine the relationship between these conditions.The general situation of children will be determined according to findings from this study.


Description:

Childhood cancers cover a wide range of diseases; leukemia, central nervous system cancers and lymphomas are the most common ones among them. Acute lymphoblastic lymphoma (ALL) is the most common childhood cancer and 78% of leukemia's reported to be ALL. During medical treatment children with leukemia are at risk of neuromuscular and musculoskeletal complications such as reduced ankle range of motion, reduced muscle strength, gross and fine motor performance impairment, decreased energy consumption, osteonecrosis and osteoporosis. These conditions can develop as a result of cancer or its treatment. These neuromuscular and musculoskeletal complications can affect dynamic balance, endurance and quality of life of the children. Childhood cancers have negative effects on sleep; sleep complaints can develop with the diagnosis and continue even after recovery period.The aim of this study is to identify the status of sleep, fatigue, and quality of life in children with various types of cancer and to examine the relationship between these conditions. In addition, families will be assessed about their children's conditions and satisfaction with the health care they receive.The general situation of children will be determined according to findings from this study.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date August 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria:

- Diagnosis of childhood cancer and having medical treatment at the hospital

Exclusion Criteria:

- Having any other health condition (neurologic, developmental or metabolic disorders)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Family based assessment
Family of the children will be assessed with questionnaires about their child health condition.

Locations

Country Name City State
Turkey Cumhuriyet University Sivas Iç Anadolu

Sponsors (2)

Lead Sponsor Collaborator
Cumhuriyet University Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Pediatric Quality of Life Inventory (PedsQL) Cancer Module Assessing the quality of life of the children with cancer. At baseline
Secondary Impact on Family Scale Assessing the impact of having a child with chronic health condition At baseline
Secondary Functional Independence Measure for children Assessing functional independence of children. At baseline
Secondary Children's Sleep Habits Questionnaire Assessing sleep duration and habits of the children. At baseline
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