NCT03190499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

June 15, 2017

Last Update Submit

August 7, 2018

Conditions

Keywords

CancerLeukemia

Outcome Measures

Primary Outcomes (1)

  • The Pediatric Quality of Life Inventory (PedsQL) Cancer Module

    Assessing the quality of life of the children with cancer.

    At baseline

Secondary Outcomes (3)

  • Impact on Family Scale

    At baseline

  • Functional Independence Measure for children

    At baseline

  • Children's Sleep Habits Questionnaire

    At baseline

Study Arms (1)

Children with childhood cancer

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

Other: Family based assessment

Interventions

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

Children with childhood cancer

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cumhuriyet University

Sivas, İç Anadolu, 58100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia

Condition Hierarchy (Ancestors)

Leukemia, LymphoidNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myeloid

Study Officials

  • Ayşe Numanoğlu Akbaş

    Ass. Prof. Dr.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Doc. Dr.

Study Record Dates

First Submitted

June 15, 2017

First Posted

June 16, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations