The Effect of a Nutrition Education Program
2026年4月23日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
80
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Istanbul
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Istanbul、Istanbul、トルコ（Türkiye）、34295
- Istanbul Aydin University, Beşyol Mah. İnönü Cad. No: 38 Küçükçekmece / İstanbul
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient Information Form
時間枠：First Day
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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).
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First Day
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Subjective Global Assessment
時間枠：First day
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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).
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First day
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Subjective Global Assessment
時間枠：at the 4th week
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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).
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at the 4th week
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Subjective Global Assessment
時間枠：at the 8th week
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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).
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at the 8th week
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Nutritional Risk Screening
時間枠：The First day
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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.
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The First day
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Nutritional Risk Screening
時間枠：at the 4th week
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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.
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at the 4th week
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Nutritional Risk Screening
時間枠：at the 8th week
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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.
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at the 8th week
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年1月20日
一次修了 (実際)
2026年3月30日
研究の完了 (実際)
2026年4月15日
試験登録日
最初に提出
2026年4月23日
QC基準を満たした最初の提出物
2026年4月23日
最初の投稿 (実際)
2026年5月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月1日
QC基準を満たした最後の更新が送信されました
2026年4月23日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。