Quality of Life in Children With Cancer


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Verified June 2017 by Ayşe Numanoğlu Akbaş, Cumhuriyet University

Sponsor:

Collaborator:

Suleyman Demirel University

Information provided by (Responsible Party):

Ayşe Numanoğlu Akbaş, Cumhuriyet University

ClinicalTrials.gov Identifier:

NCT03190499

First received: June 15, 2017

Last updated: June 15, 2017

Last verified: June 2017

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.

Childhood Cancer
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Other: Family based assessment

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: The Relationship Between Sleep, Fatigue, Quality of Life and Family Impact in Children With Cancer

Primary Outcome Measures:

Secondary Outcome Measures:

  • Impact on Family Scale [ Time Frame: At baseline ]

    Assessing the impact of having a child with chronic health condition

  • Functional Independence Measure for children [ Time Frame: At baseline ]

    Assessing functional independence of children.

  • Children’s Sleep Habits Questionnaire [ Time Frame: At baseline ]

    Assessing sleep duration and habits of the children.

Estimated Enrollment: 100
Anticipated Study Start Date: August 1, 2017
Estimated Study Completion Date: January 1, 2019
Estimated Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)
Children with childhood cancer

Children with childhood cancer that are having medical treatment will be assessed with family based questionnaires.

Other: Family based assessment

Family of the children will be assessed with questionnaires about their child health condition.

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.

Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

Study population will be recruited from children diagnosed as childhood cancer and having medical treatment in hospital.

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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03190499

Cumhuriyet University

Suleyman Demirel University

Study Director: Ayşe Numanoğlu Akbaş Ass. Prof. Dr.

Responsible Party: Ayşe Numanoğlu Akbaş, Ass. Doc. Dr., Cumhuriyet University
ClinicalTrials.gov Identifier: NCT03190499     History of Changes
Other Study ID Numbers: ALL_AML
Study First Received: June 15, 2017
Last Updated: June 15, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ayşe Numanoğlu Akbaş, Cumhuriyet University:

Cancer
Leukemia

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on June 16, 2017