Clinical trial NCT03190499: Quality of Life in Children With Cancer
Official title: The Relationship Between Sleep, Fatigue, Quality of Life and Family Impact in Children With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Cancer
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Keywords: Cancer
Leukemia
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
Collaborators: name: Suleyman Demirel University
First posted: 2017-06-16
Enrollment: 74
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be recruited from children diagnosed as childhood cancer and having medical treatment in hospital.

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The Pediatric Quality of Life Inventory (PedsQL) Cancer Module
timeFrame: At baseline
Secondary outcomes:
measure: Impact on Family Scale
timeFrame: At baseline
measure: Functional Independence Measure for children
timeFrame: At baseline
measure: Children's Sleep Habits Questionnaire
timeFrame: At baseline
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Cumhuriyet University
state: İç Anadolu
Study officials:
affiliation: Ass. Prof. Dr.
name: Ayşe Numanoğlu Akbaş
role: STUDY_DIRECTOR
References: