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The Effect of a Nutrition Education Program

23 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Turchia (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turchia (Türkiye), 34295
        • Istanbul Aydin University, Beşyol Mah. İnönü Cad. No: 38 Küçükçekmece / İstanbul

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Nutrition Education Program
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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient Information Form
Lasso di tempo: First Day
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).
First Day
Subjective Global Assessment
Lasso di tempo: First day
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).
First day
Subjective Global Assessment
Lasso di tempo: at the 4th week
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).
at the 4th week
Subjective Global Assessment
Lasso di tempo: at the 8th week
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).
at the 8th week
Nutritional Risk Screening
Lasso di tempo: The First day
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.
The First day
Nutritional Risk Screening
Lasso di tempo: at the 4th week
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.
at the 4th week
Nutritional Risk Screening
Lasso di tempo: at the 8th week
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.
at the 8th week

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Istanbul Aydın University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 gennaio 2024

Completamento primario (Effettivo)

30 marzo 2026

Completamento dello studio (Effettivo)

15 aprile 2026

Date di iscrizione allo studio

Primo inviato

23 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • Nutrition Education Program

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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