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

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.

Study Overview

• Status: Completed
• Conditions: Cancer Patient
• Intervention / Treatment: Other: Nutrition Education Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Information Form	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Istanbul Aydın University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2024
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): April 15, 2026

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Nutritional status; Nutritional intervention; Cancer patients
• Other Study ID Numbers: Nutrition Education Program

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No