- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03190499
Quality of Life in Children With Cancer (sıcc)
August 7, 2018 updated by: Ayşe Numanoğlu Akbaş, Cumhuriyet University
The Relationship Between Sleep, Fatigue, Quality of Life and Family Impact in Children With Cancer
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
74
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
İç Anadolu
-
Sivas, İç Anadolu, Turkey, 58100
- Cumhuriyet University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Study population will be recruited from children diagnosed as childhood cancer and having medical treatment in hospital.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children with childhood cancer
Children with childhood cancer that are having medical treatment will be assessed with family based questionnaires.
|
Family of the children will be assessed with questionnaires about their child health condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Pediatric Quality of Life Inventory (PedsQL) Cancer Module
Time Frame: At baseline
|
Assessing the quality of life of the children with cancer.
|
At baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact on Family Scale
Time Frame: At baseline
|
Assessing the impact of having a child with chronic health condition
|
At baseline
|
|
Functional Independence Measure for children
Time Frame: At baseline
|
Assessing functional independence of children.
|
At baseline
|
|
Children's Sleep Habits Questionnaire
Time Frame: At baseline
|
Assessing sleep duration and habits of the children.
|
At baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Ayşe Numanoğlu Akbaş, Ass. Prof. Dr.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
June 15, 2017
First Submitted That Met QC Criteria
June 15, 2017
First Posted (Actual)
June 16, 2017
Study Record Updates
Last Update Posted (Actual)
August 8, 2018
Last Update Submitted That Met QC Criteria
August 7, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALL_AML
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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