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Enrolling by invitation NCT07606170

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

Observational Childhood Cancer Fatigue Daily Activities Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Childhood Cancer, Fatigue, Daily Activities, Quality of Life. Basic parameters: 2 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Fatigue on Quality of Life and Daily Living Activities in Patients Treated in the Pediatric Oncology Department

Overview

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.

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.

Primary outcome measures

  • Pediatric (Paediatric) Functional Assessment of Chronic Illness Therapy -Fatigue [Time frame: Last 7 days.]
  • Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL™ Multidimensional Fatigue Scale) [Time frame: Last 1 month.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • İstanbul Medipol University — Istanbul

Publications

  • 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
  • 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
  • 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.
  • 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

Identifiers

NCT: NCT07606170 · E-10840098-202.3.02-1245

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗