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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye)
        • Istanbul Medipol 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pediatric (Paediatric) Functional Assessment of Chronic Illness Therapy -Fatigue
Time Frame: Last 7 days.
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.
Last 7 days.
Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL™ Multidimensional Fatigue Scale)
Time Frame: Last 1 month.
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.
Last 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipol University

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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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