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Nutrition Education Program for Postoperative Patients With Gastric Cancer

Primary Purpose

Gastric Cancer, Nutrition Disorders

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
standardized nutrition education
routine nutrition education
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring gastric cancer, nutrition, health education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

experimental group

Arm Description

Outcomes

Primary Outcome Measures

risk of malnutrition
Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
risk of malnutrition
Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
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.
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.
albumin
level of serum albumin
albumin
level of serum albumin
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.
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.

Secondary Outcome Measures

physical function status
Using Eastern Cooperative Oncology Group to assess the physical function.
physical function status
Using Eastern Cooperative Oncology Group to assess the physical function.
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.

Full Information

First Posted
May 5, 2019
Last Updated
May 19, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03952442
Brief Title
Nutrition Education Program for Postoperative Patients With Gastric Cancer
Official Title
The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Postoperative Patients With Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Nutrition Disorders
Keywords
gastric cancer, nutrition, health education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Title
experimental group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
standardized nutrition education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
routine nutrition education
Intervention Description
Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients.
Primary Outcome Measure Information:
Title
risk of malnutrition
Description
Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
Time Frame
Week 0
Title
risk of malnutrition
Description
Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
Time Frame
Week 12
Title
BMI
Description
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.
Time Frame
Week 0
Title
BMI
Description
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.
Time Frame
Week 12
Title
albumin
Description
level of serum albumin
Time Frame
Week 0
Title
albumin
Description
level of serum albumin
Time Frame
Week 12
Title
Quality of Life (QOL)
Description
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.
Time Frame
Week 0
Title
Quality of Life (QOL)
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
physical function status
Description
Using Eastern Cooperative Oncology Group to assess the physical function.
Time Frame
Week 0
Title
physical function status
Description
Using Eastern Cooperative Oncology Group to assess the physical function.
Time Frame
Week 12
Title
Knowledge-Attitude-Practice
Description
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.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
31009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Zhou, Bachelor
Phone
13857160575
Email
731061631@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Nutrition Education Program for Postoperative Patients With Gastric Cancer

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