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Completed

NCT Number: NCT07560605

The Effect of a Nutrition Education Program

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.

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Key information

Conditions

Cancer Patient

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, 34295, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Patient Information Form

    Time frame: 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).

  2. Subjective Global Assessment

    Time frame: 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).

  3. Subjective Global Assessment

    Time frame: 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).

  4. Subjective Global Assessment

    Time frame: 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).

  5. Nutritional Risk Screening

    Time frame: 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.

  6. Nutritional Risk Screening

    Time frame: 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.

  7. Nutritional Risk Screening

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Official study title

The Effect of a Nutrition Education Program on Dietary Intake and Nutritional Status in Cancer Patients: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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