The Effect of a Nutrition Education Program

NCT07560605 | Completed

• 1 other identifier: Nutrition Education Program
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Patient

Keywords

Cancer patients; Nutritional status; Randomized controlled trial; Nutritional intervention

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Nutrition Education Program OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul Aydın University: lead

Study Sites (1)

Istanbul Aydin University, Beşyol Mah. İnönü Cad. No: 38 Küçükçekmece / İstanbul

Istanbul, Istanbul, 34295, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 1, 2026
• Study Start: January 20, 2024
• Primary Completion: March 30, 2026
• Study Completion: April 15, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)