- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07606170
The Impact of Fatigue on Quality of Life and Activities of Daily Living in Pediatric Oncology Patients
May 23, 2026 updated by: Ahmet Emir, Medipol University
The Effect of Fatigue on Quality of Life and Daily Living Activities in Patients Treated in the Pediatric Oncology Department
This study aims to examine the impact of fatigue on the quality of life and daily living activities of children undergoing cancer treatment.In this cross-sectional study of 89 children aged 2-18 years, fatigue, quality of life, and functional independence were assessed using various scales.The basic hypothesis of the study is that as fatigue increases, children's daily activities and quality of life will be negatively affected.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
This study, starting from the fact that childhood cancers remain a significant health problem, focuses on fatigue, a symptom frequently observed in these patients and affecting their lives in multifaceted ways.
Cancer and the treatment process have effects on physical, emotional, and cognitive areas, negatively impacting children's participation in daily living activities, social relationships, and overall quality of life.
In this context, fatigue is considered not merely a temporary weakness, but a multidimensional condition that reduces an individual's overall well-being and functional independence.The main aim of this study is to examine the relationship between fatigue level and functional independence and health-related quality of life in children treated in the pediatric oncology ward.
The study tests the hypothesis that as fatigue levels increase, children's independence in daily living activities decreases and their quality of life declines.
Accordingly, the study aims to contribute to clinical practice by revealing the impact of fatigue on children's lives.The research has a cross-sectional and observational design and is conducted with a total of 89 pediatric oncology patients aged 2-18 years treated at Istanbul Medipol University hospitals.
The fatigue level, quality of life, and functional independence of the individuals participating in the study are assessed using various validated and reliable measurement tools.
The FACIT-F and PedsQL Multidimensional Fatigue Scale are used for fatigue, the PedsQL Cancer Module for quality of life, and the WeeFIM scale for activities of daily living.
Data are collected through face-to-face interviews and online forms, and the obtained data are evaluated using statistical analysis methods.The study is expected to reveal significant relationships between fatigue level and quality of life and activities of daily living in pediatric oncology patients.
In particular, it is predicted that increased fatigue negatively affects both the physical independence and psychosocial well-being of children.
The aim is for the findings to contribute to the development of occupational therapy-based interventions for fatigue management in this patient group and to guide clinical practice.
Study Type
Observational
Enrollment (Estimated)
89
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
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye)
- Istanbul Medipol University
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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
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study sample consists of patients aged 2-18 years receiving treatment in the pediatric oncology departments of specific hospitals.
This study is designed as a cross-sectional study and will involve correlational analysis.
89 pediatric oncology patients aged 2-18 years will be selected from Istanbul Medipol University MegaHospitals Complex and Istanbul Medipol University Occupational Therapy Unit.
Description
Inclusion Criteria:
- Being diagnosed with cancer and actively undergoing treatment.
- Being a child/adolescent between the ages of 2 and 18.
- Volunteering to participate in the study and obtaining informed consent from a parent/legal guardian are required.
Exclusion Criteria:
- In addition to the oncological diagnosis, the patient may have an additional chronic illness (cardiac, renal, metabolic, etc.) that could affect the outcome.
- Having a serious cognitive or neurological disability that limits the ability to apply data collection tools.
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 |
|---|
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Pediatric oncology patients
Pediatric oncology patients are children and adolescents aged 0-18 years who have been diagnosed with any malignancy (cancer) and are actively undergoing treatment.
This patient group includes childhood cancers such as leukemia, lymphoma, brain tumors, bone tumors, and other solid tumors.
Pediatric oncology patients are affected not only physically but also emotionally, cognitively, and socially due to the disease itself and the treatment methods applied (chemotherapy, radiotherapy, surgery).
In this process, fatigue stands out as a significant symptom that negatively affects children's participation in daily life activities, functional independence, and quality of life.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pediatric (Paediatric) Functional Assessment of Chronic Illness Therapy -Fatigue
Time Frame: Last 7 days.
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The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item instrument used to evaluate fatigue levels in individuals.
Items are scored on a 5-point Likert scale, with total scores ranging from 0 to 52.
Higher scores indicate lower levels of fatigue and better functional status.
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Last 7 days.
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Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL™ Multidimensional Fatigue Scale)
Time Frame: Last 1 month.
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The Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL™ Multidimensional Fatigue Scale) is an 18-item instrument used to assess multidimensional fatigue in children.
The scale consists of three subscales: General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue.
Items are scored on a 5-point Likert scale and transformed to a 0-100 scale.
Higher scores indicate lower levels of fatigue and better functioning.
The minimum possible score is 0 and the maximum possible score is 100.
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Last 1 month.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
- Msall ME, DiGaudio K, Rogers BT, LaForest S, Catanzaro NL, Campbell J, Wilczenski F, Duffy LC. The Functional Independence Measure for Children (WeeFIM). Conceptual basis and pilot use in children with developmental disabilities. Clin Pediatr (Phila). 1994 Jul;33(7):421-30. doi: 10.1177/000992289403300708.
- Varni JW, Katz ER, Seid M, Quiggins DJ, Friedman-Bender A. The pediatric cancer quality of life inventory-32 (PCQL-32): I. Reliability and validity. Cancer. 1998 Mar 15;82(6):1184-96. doi: 10.1002/(sici)1097-0142(19980315)82:63.0.co;2-1.
- FACIT-F Cella D, Tulsky D, Gray G, Sarafian B, Linn E, Bonomi A, et al. The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: development and validation of a new measure of fatigue. J Clin Epidemiol. 2002;55(3):266-278.
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)
February 1, 2026
Primary Completion (Estimated)
June 10, 2026
Study Completion (Estimated)
July 10, 2026
Study Registration Dates
First Submitted
May 12, 2026
First Submitted That Met QC Criteria
May 18, 2026
First Posted (Actual)
May 26, 2026
Study Record Updates
Last Update Posted (Actual)
May 28, 2026
Last Update Submitted That Met QC Criteria
May 23, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-1245
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data can be shared upon reasonable request.
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
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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