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出境医 / 临床实验 / Nutrition Education Program for Postoperative Patients With Gastric Cancer

Nutrition Education Program for Postoperative Patients With Gastric Cancer

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Nutrition Disorders Other: standardized nutrition education Other: routine nutrition education Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Postoperative Patients With Gastric Cancer
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: control group Other: routine nutrition education
Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients.
Experimental: experimental group 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.
Outcome Measures
Primary Outcome Measures :
  1. risk of malnutrition [ Time Frame: Week 0 ]
    Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.

  2. risk of malnutrition [ Time Frame: Week 12 ]
    Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.

  3. BMI [ Time Frame: Week 0 ]
    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.

  4. BMI [ Time Frame: Week 12 ]
    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.

  5. albumin [ Time Frame: Week 0 ]
    level of serum albumin

  6. albumin [ Time Frame: Week 12 ]
    level of serum albumin

  7. Quality of Life (QOL) [ Time Frame: Week 0 ]
    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.

  8. Quality of Life (QOL) [ Time Frame: Week 12 ]
    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 :
  1. physical function status [ Time Frame: Week 0 ]
    Using Eastern Cooperative Oncology Group to assess the physical function.

  2. physical function status [ Time Frame: Week 12 ]
    Using Eastern Cooperative Oncology Group to assess the physical function.

  3. Knowledge-Attitude-Practice [ Time Frame: Week 12 ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
China, Zhejiang
Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 31009
Contact: Haiyan Zhou, Bachelor    13857160575    731061631@qq.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE February 21, 2019
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2019)
  • risk of malnutrition [ Time Frame: Week 0 ]
    Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
  • risk of malnutrition [ Time Frame: Week 12 ]
    Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
  • BMI [ Time Frame: Week 0 ]
    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 [ Time Frame: Week 12 ]
    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 [ Time Frame: Week 0 ]
    level of serum albumin
  • albumin [ Time Frame: Week 12 ]
    level of serum albumin
  • Quality of Life (QOL) [ Time Frame: Week 0 ]
    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) [ Time Frame: Week 12 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • risk of malnutrition [ Time Frame: Week 0 ]
    Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
  • risk of malnutrition [ Time Frame: Week 12 ]
    Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
  • BMI [ Time Frame: Week 0 ]
    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 [ Time Frame: Week 12 ]
    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 [ Time Frame: Week 0 ]
    level of serum albumin
  • albumin [ Time Frame: Week 12 ]
    level of serum albumin
  • life quality [ Time Frame: Week 0 ]
    Using Functional Assessment of Cancer Therapy and European Organization for Research and Treatment-Quality of Life Questionnaire to assess the quality of life.
  • life quality [ Time Frame: Week 12 ]
    Using Functional Assessment of Cancer Therapy and European Organization for Research and Treatment-Quality of Life Questionnaire to assess the quality of life.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • physical function status [ Time Frame: Week 0 ]
    Using Eastern Cooperative Oncology Group to assess the physical function.
  • physical function status [ Time Frame: Week 12 ]
    Using Eastern Cooperative Oncology Group to assess the physical function.
  • Knowledge-Attitude-Practice [ Time Frame: Week 12 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutrition Education Program for Postoperative Patients With Gastric Cancer
Official Title  ICMJE The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Postoperative Patients With Gastric Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Gastric Cancer
  • Nutrition Disorders
Intervention  ICMJE
  • 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.
  • Other: routine nutrition education
    Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients.
Study Arms  ICMJE
  • Active Comparator: control group
    Intervention: Other: routine nutrition education
  • Experimental: experimental group
    Intervention: Other: standardized nutrition education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952442
Other Study ID Numbers  ICMJE 2018-211
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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