- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07606170
The Impact of Fatigue on Quality of Life and Activities of Daily Living in Pediatric Oncology Patients
23. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Påmelding etter invitasjon
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
89
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Istanbul
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Istanbul, Istanbul, Tyrkia (Türkiye)
- Istanbul Medipol University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pediatric (Paediatric) Functional Assessment of Chronic Illness Therapy -Fatigue
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2026
Primær fullføring (Antatt)
10. juni 2026
Studiet fullført (Antatt)
10. juli 2026
Datoer for studieregistrering
Først innsendt
12. mai 2026
Først innsendt som oppfylte QC-kriteriene
18. mai 2026
Først lagt ut (Faktiske)
26. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E-10840098-202.3.02-1245
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Data can be shared upon reasonable request.
IPD-deling Støtteinformasjonstype
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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