The Impact of Fatigue on Quality of Life and Activities of Daily Living in Pediatric Oncology Patients

NCT07606170 | Enrolling By Invitation

• 1 other identifier: E-10840098-202.3.02-1245
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Cancer; Fatigue; Daily Activities; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Pediatric (Paediatric) Functional Assessment of Chronic Illness Therapy -Fatigue

  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)

  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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

İstanbul Medipol University

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 9506367 BACKGROUND

• 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.

  PMID: 7525140 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11932914 BACKGROUND

Related Links

• Everything about The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
• Everything about Pediatric Quality of Life Inventory™ Cancer Module (PedsQL™ Cancer Module)

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 26, 2026
• Study Start: February 1, 2026
• Primary Completion: June 10, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

TU (1)