- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07560605
The Effect of a Nutrition Education Program
The Effect of a Nutrition Education Program on Dietary Intake and Nutritional Status in Cancer Patients: A Randomized Controlled Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Istanbul
-
Istanbul, Istanbul, Türkei (türkiye), 34295
- Istanbul Aydin University, Beşyol Mah. İnönü Cad. No: 38 Küçükçekmece / İstanbul
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
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.
|
|
Kein Eingriff: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Patient Information Form
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- Nutrition Education Program
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .