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临床试验/NCT03952442
NCT03952442Unknown不适用

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年2月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
BMI

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are diagnosed with gastric cancer and receive operation.
  • Patients need nutrition support treatment
  • Informed consent.

排除标准

  • 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

研究组 & 干预措施

control group

Active Comparator

干预措施: routine nutrition education (Other)

experimental group

Experimental

干预措施: standardized nutrition education (Other)

结局指标

主要结局

BMI

时间窗: 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

时间窗: Week 12

level of serum albumin

Quality of Life (QOL)

时间窗: 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.

risk of malnutrition

时间窗: Week 12

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

次要结局

  • Knowledge-Attitude-Practice(Week 12)
  • physical function status(Week 12)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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