Nutrition Education Program for Postoperative Patients With Gastric Cancer

Study Overview
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Brief Summary
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Using randomized control study, explore the effect of standardized nutrition education program on the nutrition status and life quality of patients with gastric cancer after surgery.

Official Title
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The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Postoperative Patients With Gastric Cancer

Conditions
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Gastric Cancer, Nutrition Disorders

Intervention / Treatment
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* Other: standardized nutrition education
* Other: routine nutrition education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are diagnosed with gastric cancer and receive operation. Patients need nutrition support treatment Informed consent. Exclusion Criteria: Critical patients or stage IV Patients with severe hepatic cirrhosis, Chronic Obstructive Pulmonary Disease, chronic renal failure, intestinal obstruction, stroke. Unconscious or psychiatric patients Patients with communication problems

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br> | Other: routine nutrition education<br>* Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients.<br>|
| Experimental: experimental group<br> | Other: standardized nutrition education<br>* Give nutrition health education every two weeks and regular survey and intervention. The education booklets are made based on the guideline and characteristics of the disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk of malnutrition | Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition. | Week 0 | 
| risk of malnutrition | Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition. | Week 12 | 
| BMI | Body mass index is a measure of body fat based on height and weight that applies to adult men and women. It equals to weight divided by height square. | Week 0 | 
| BMI | Body mass index is a measure of body fat based on height and weight that applies to adult men and women. It equals to weight divided by height square. | Week 12 | 
| albumin | level of serum albumin | Week 0 | 
| albumin | level of serum albumin | Week 12 | 
| Quality of Life (QOL) | The QOL was measured by the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) simplified Chinese version. It contains five functional scales (physical, role, cognitive, emotional, and social), three symptoms scales (fatigue, pain, and nausea and vomiting), a global health scale, a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and financial impact of the disease. For most items, four response categories from 1 (not at all) to 4 (very much) are employed; two items (overall health, overall quality of life) have response categories ranging from 1 to 7. A high scale score represents a higher response level. Thus a high score for a functional scale, the global health status or overall QOL represents a high or healthy status or a high QOL; however, a high score for the symptom scales represents a high level of symptom. | Week 0 | 
| Quality of Life (QOL) | The QOL was measured by the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) simplified Chinese version. It contains five functional scales (physical, role, cognitive, emotional, and social), three symptoms scales (fatigue, pain, and nausea and vomiting), a global health scale, a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and financial impact of the disease. For most items, four response categories from 1 (not at all) to 4 (very much) are employed; two items (overall health, overall quality of life) have response categories ranging from 1 to 7. A high scale score represents a higher response level. Thus a high score for a functional scale, the global health status or overall QOL represents a high or healthy status or a high QOL; however, a high score for the symptom scales represents a high level of symptom. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical function status | Using Eastern Cooperative Oncology Group to assess the physical function. | Week 0 | 
| physical function status | Using Eastern Cooperative Oncology Group to assess the physical function. | Week 12 | 
| Knowledge-Attitude-Practice | Knowledge Scale composes of 10 questions and 10 scores for each question. Attitude and Practice Scale have 5 questions. Each question is rated as A、B、C. A represents 20 score and B is 10 score. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, nutrition, health education