- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Istanbul
-
Istanbul, Istanbul, 터키 (Türkiye), 34295
- Istanbul Aydin University, Beşyol Mah. İnönü Cad. No: 38 Küçükçekmece / İstanbul
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient Information Form
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .