Nutrition Education Program for Postoperative Patients With Gastric Cancer
The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Postoperative Patients With Gastric Cancer
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable gastric-cancer
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2019
CompletedFirst Submitted
Initial submission to the registry
May 5, 2019
CompletedFirst Posted
Study publicly available on registry
May 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 21, 2019
May 1, 2019
1.7 years
May 5, 2019
May 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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 Outcomes (3)
physical function status
Week 0
physical function status
Week 12
Knowledge-Attitude-Practice
Week 12
Study Arms (2)
control group
ACTIVE COMPARATORexperimental group
EXPERIMENTALInterventions
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.
Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients.
Eligibility Criteria
You may qualify if:
- Patients are diagnosed with gastric cancer and receive operation.
- Patients need nutrition support treatment
- Informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 31009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2019
First Posted
May 16, 2019
Study Start
February 21, 2019
Primary Completion
October 30, 2020
Study Completion
December 31, 2020
Last Updated
May 21, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share