Childhood CancersıccNCT03190499
Quality of Life in Children With Cancer
An observational study of Childhood Cancer and Acute Lymphoblastic Leukemia, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Childhood Cancer, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- What is being tested?
- Family based assessment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2017to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Study population will be recruited from children diagnosed as childhood cancer and having medical treatment in hospital.
Who may be able to join
- Diagnosis of childhood cancer and having medical treatment at the hospital
Who cannot join
- Having any other health condition (neurologic, developmental or metabolic disorders)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cumhuriyet University
Sivas, İç Anadolu, 58100
About this study
Official title: 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.
Read the 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.
- Being tested
- Family based assessment
- Keywords
- Cancer, Leukemia
- Medical subject headings
- Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family based assessmentOther
Family of the children will be assessed with questionnaires about their child health condition.
| Study group | Role | What they receive |
|---|---|---|
| Children with childhood cancer | Children with childhood cancer that are having medical treatment will be assessed with family based questionnaires. Receives: Other: Family based assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pediatric Quality of Life Inventory (PedsQL) Cancer Module
Assessing the quality of life of the children with cancer.
Measured: At baseline
Secondary outcomes (3)
Impact on Family Scale
Assessing the impact of having a child with chronic health condition
Measured: At baseline
Functional Independence Measure for children
Assessing functional independence of children.
Measured: At baseline
Children's Sleep Habits Questionnaire
Assessing sleep duration and habits of the children.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Aug 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Suleyman Demirel University
- Responsible party
- Principal investigator, Ayşe Numanoğlu Akbaş, Cumhuriyet University
- Investigators
- Ayşe Numanoğlu Akbaş, Study director, Ass. Prof. Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190499
- Sponsor's protocol ID
- ALL_AML
- Acronym
- sıcc
- Status last verified
- Aug 2018
- First submitted
- 15 Jun 2017
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Sleep, Fatigue, Quality of Life and Family Impact in Children With Cancer
- ClinicalTrials.gov ID
- NCT03190499
- Acronym / sponsor ID
- sıcc / ALL_AML
- Keywords
- Cancer, Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Collaborators
- Suleyman Demirel University
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with childhood cancer | – | Other: Family based assessmentChildren with childhood cancer that are having medical treatment will be assessed with family based questionnaires. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Study population will be recruited from children diagnosed as childhood cancer and having medical treatment in hospital.
Key inclusion criteria (1 listed)
- Diagnosis of childhood cancer and having medical treatment at the hospital
Key exclusion criteria (1 listed)
- Having any other health condition (neurologic, developmental or metabolic disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family based assessmentFamily of the children will be assessed with questionnaires about their child health condition. | Other | Children with childhood cancer |
Primary outcome
The Pediatric Quality of Life Inventory (PedsQL) Cancer Module
Time frame: At baseline
Assessing the quality of life of the children with cancer.
3 secondary outcomes
Impact on Family Scale
Time frame: At baseline
Functional Independence Measure for children
Time frame: At baseline
Children's Sleep Habits Questionnaire
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Numanoğlu Akbaş study director
Ass. Prof. Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer and Acute Lymphoblastic Leukemia, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pediatric Quality of Life Inventory (PedsQL) Cancer Module (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.