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Nutrition Education Program for Postoperative Patients With Gastric Cancer

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ClinicalTrials.gov Identifier: NCT03952442
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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.




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. 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.

  8. 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.


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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952442


Locations
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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

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03952442     History of Changes
Other Study ID Numbers: 2018-211
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
gastric cancer
nutrition
health education

Additional relevant MeSH terms:
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Stomach Neoplasms
Nutrition Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases