The Effect of a Nutrition Education Program
23 de abril de 2026 atualizado por: DİLEK YILDIRIM, Istanbul Aydın University
The Effect of a Nutrition Education Program on Dietary Intake and Nutritional Status in Cancer Patients: A Randomized Controlled Trial
This study is a randomized controlled trial aimed at evaluating the effect of a nutritional education program on dietary intake and nutritional status in cancer patients.
Patients were randomly assigned to intervention and control groups, with the intervention group receiving structured nutritional education.
Participants' nutritional status and daily dietary intake were assessed at baseline and during the follow-up period.
The study aims to demonstrate that nutritional education can increase food intake and be effective in improving nutritional status in patients.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This study is a randomized controlled trial designed to evaluate the effectiveness of a structured nutritional education program in improving nutritional status in cancer patients. In cancer patients, the disease itself and the treatments administered (chemotherapy, radiotherapy, etc.) increase the risk of malnutrition due to decreased appetite, taste alterations, nausea, vomiting, and metabolic changes. Therefore, nutritional interventions are critically important for clinical outcomes in this group.
Patients included in the study were randomly assigned to intervention and control groups. The intervention group received an individualized and structured nutritional education program. This program included the importance of adequate energy and protein intake, nutritional strategies for symptoms, appropriate food selection, meal planning, and practical nutritional recommendations. The training was supported by both face-to-face sessions and follow-up interviews as needed. The control group continued with routine clinical care.
The nutritional status of the patients was assessed at baseline and at designated follow-up intervals. Clinical nutritional screening tools (such as NRS-2002), anthropometric measurements (body weight, BMI), and food intake records were used to determine nutritional status. Daily energy and protein intakes of the patients were also analyzed.
The primary aim of this study is to determine whether nutritional education increases patients' dietary intake and consequently reduces their risk of malnutrition. The impact of the educational intervention on patients' nutritional awareness, symptom management, and overall eating behaviors is also evaluated.
The results are expected to contribute to the inclusion of nutritional education as a standard intervention in nursing care for oncology patients and to guide clinical practice.
Tipo de estudo
Intervencional
Inscrição (Real)
80
Estágio
- Não aplicável
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), 34295
- Istanbul Aydin University, Beşyol Mah. İnönü Cad. No: 38 Küçükçekmece / İstanbul
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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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Adult patients diagnosed with cancer (>18 years)
- Receiving active cancer treatment (chemotherapy and/or radiotherapy)
- Able to take oral nutrition
- Willing and able to participate in the nutrition education program
- Provided written informed consent
Exclusion Criteria:
- Patients receiving enteral or parenteral nutrition
- Severe cognitive impairment or inability to communicate
- Critical or terminal condition preventing participation in education sessions
- Severe comorbidities affecting dietary intake independently (e.g., advanced heart failure, end-stage renal disease)
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
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Experimental Group
Participants in the experimental group received a structured and individualized nutrition education program in addition to routine clinical care.
The intervention was delivered by a trained healthcare professional and focused on improving dietary intake and nutritional status in cancer patients.
The program included education on adequate energy and protein intake, management of treatment-related symptoms affecting nutrition (such as nausea, anorexia, and taste changes), appropriate food selection, meal planning strategies, and practical dietary recommendations tailored to individual needs.
The education was provided through face-to-face sessions with follow-up reinforcement sessions during the study period.
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The intervention consisted of a structured and individualized nutrition education program designed for cancer patients.
The program was delivered by a trained healthcare professional and aimed to improve dietary intake and nutritional status.
It included education on adequate energy and protein consumption, management of treatment-related symptoms affecting food intake (such as nausea, anorexia, and taste changes), appropriate food selection, meal planning strategies, and practical dietary recommendations tailored to individual needs.
The intervention was implemented through face-to-face educational sessions with follow-up reinforcement during the study period, in addition to routine clinical care.
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Sem intervenção: Control Group
Participants in the control group received routine clinical care only during the study period.
No structured nutrition education or additional dietary counseling was provided beyond standard hospital practices.
Patients continued their usual follow-up and medical care as determined by their treating healthcare team.
Nutritional status and dietary intake assessments were performed at the same time points as in the experimental group for comparison purposes.
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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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Patient Information Form
Prazo: First Day
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The Patient Information Form was developed by the researchers in accordance with the relevant literature.
It included items related to patients' sociodemographic and clinical characteristics, such as age, gender, educational status, presence and site of metastasis, number of chemotherapy cycles administered at the time of enrollment, chemotherapy schedule, chemotherapy regimen, and type of chemotherapy (adjuvant or neoadjuvant).
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First Day
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Subjective Global Assessment
Prazo: First day
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The SGA is a nutritional assessment tool, which has been shown to demonstrate a strong correlation between subjective clinical judgment and objective nutritional measures.
Due to its simplicity and predictive validity comparable to objective methods, it is widely used in clinical practice.
The SGA includes components such as medical history (weight change over the past six months, dietary intake changes, gastrointestinal symptoms such as anorexia, nausea, vomiting, and diarrhea), as well as functional capacity.
Physical examination findings assess subcutaneous fat loss, muscle wasting, and edema, each scored as 0 (normal), 1+ (mild), 2+ (moderate), or 3+ (severe).
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First day
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Subjective Global Assessment
Prazo: at the 4th week
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The SGA is a nutritional assessment tool, which has been shown to demonstrate a strong correlation between subjective clinical judgment and objective nutritional measures.
Due to its simplicity and predictive validity comparable to objective methods, it is widely used in clinical practice.
The SGA includes components such as medical history (weight change over the past six months, dietary intake changes, gastrointestinal symptoms such as anorexia, nausea, vomiting, and diarrhea), as well as functional capacity.
Physical examination findings assess subcutaneous fat loss, muscle wasting, and edema, each scored as 0 (normal), 1+ (mild), 2+ (moderate), or 3+ (severe).
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at the 4th week
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Subjective Global Assessment
Prazo: at the 8th week
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The SGA is a nutritional assessment tool, which has been shown to demonstrate a strong correlation between subjective clinical judgment and objective nutritional measures.
Due to its simplicity and predictive validity comparable to objective methods, it is widely used in clinical practice.
The SGA includes components such as medical history (weight change over the past six months, dietary intake changes, gastrointestinal symptoms such as anorexia, nausea, vomiting, and diarrhea), as well as functional capacity.
Physical examination findings assess subcutaneous fat loss, muscle wasting, and edema, each scored as 0 (normal), 1+ (mild), 2+ (moderate), or 3+ (severe).
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at the 8th week
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Nutritional Risk Screening
Prazo: The First day
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The NRS-2002 aims to identify malnutrition and the risk of malnutrition, and to determine patients who may benefit from nutritional support.
The scoring system consists of two sections: 'nutritional status' and 'disease severity,' and allows for scoring as 'no problem,' 'mild,' 'moderate,' and 'severe.'
Each section is scored from 0 to 3. In patients over seventy years of age, an additional 1 point is added to the score due to age.
Patients with a total score ≥3 are considered to be at nutritional risk.
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The First day
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Nutritional Risk Screening
Prazo: at the 4th week
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The NRS-2002 aims to identify malnutrition and the risk of malnutrition, and to determine patients who may benefit from nutritional support.
The scoring system consists of two sections: 'nutritional status' and 'disease severity,' and allows for scoring as 'no problem,' 'mild,' 'moderate,' and 'severe.'
Each section is scored from 0 to 3. In patients over seventy years of age, an additional 1 point is added to the score due to age.
Patients with a total score ≥3 are considered to be at nutritional risk.
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at the 4th week
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Nutritional Risk Screening
Prazo: at the 8th week
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The NRS-2002 aims to identify malnutrition and the risk of malnutrition, and to determine patients who may benefit from nutritional support.
The scoring system consists of two sections: 'nutritional status' and 'disease severity,' and allows for scoring as 'no problem,' 'mild,' 'moderate,' and 'severe.'
Each section is scored from 0 to 3. In patients over seventy years of age, an additional 1 point is added to the score due to age.
Patients with a total score ≥3 are considered to be at nutritional risk.
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at the 8th week
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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)
20 de janeiro de 2024
Conclusão Primária (Real)
30 de março de 2026
Conclusão do estudo (Real)
15 de abril de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
23 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de abril de 2026
Primeira postagem (Real)
1 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Nutrition Education Program
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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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