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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07606170
The Impact of Fatigue on Quality of Life and Activities of Daily Living in Pediatric Oncology Patients
23 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Inscrevendo-se por convite
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Estimado)
89
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Istanbul
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Istanbul, Istanbul, Turquia (Türkiye)
- Istanbul Medipol University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Pediatric (Paediatric) Functional Assessment of Chronic Illness Therapy -Fatigue
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de fevereiro de 2026
Conclusão Primária (Estimado)
10 de junho de 2026
Conclusão do estudo (Estimado)
10 de julho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
12 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de maio de 2026
Primeira postagem (Real)
26 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- E-10840098-202.3.02-1245
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Data can be shared upon reasonable request.
Tipo de informação de suporte de compartilhamento de IPD
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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