Nutrition Education Program for Postoperative Patients With Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03952442
• Other study ID #: 2018-211
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Nutrition Disorders
• Stomach Neoplasms

Intervention

Other:
• standardized nutrition education
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.
• routine nutrition education
Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients.

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	risk of malnutrition	Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.	Week 0
Primary	risk of malnutrition	Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.	Week 12
Primary	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
Primary	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
Primary	albumin	level of serum albumin	Week 0
Primary	albumin	level of serum albumin	Week 12
Primary	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
Primary	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	physical function status	Using Eastern Cooperative Oncology Group to assess the physical function.	Week 0
Secondary	physical function status	Using Eastern Cooperative Oncology Group to assess the physical function.	Week 12
Secondary	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