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临床试验/NCT03766945
NCT03766945Unknown不适用

A Survey of Fatigue and QoL Among Gastric Cancer Patients Undergoing Major Abdominal Surgery

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年7月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Fatigue

研究概览

简要总结

Background: Cancer-related fatigue (CRF), one of the indicators of QoL, is one of the most common side effects of cancer and its treatment. However, the pathophysiological mechanisms involved in CRF among cancer patients are not completely understood. Therefore, more in-depth researches on CRF of surgical patients suffering from gastric cancer are needed in Taiwan.

Purpose: The purpose of this study is to examine the incidence rate and correlated factors (QoL and immune biomarkers) of CRF among gastric cancer patients undergoing major abdominal surgery.

Method: A longitudinal study was conducted to recruit gastric cancer patients who scheduled to operate at surgical clinics from a northern medical center in Taiwan. The data will be collected with a structured questionnaire and Immune markers assessments via purposive sampling of 120 subjects. Before operation, on day 1 after operation, and on day 7 after operation, the biomarkers will be measured. The BFI-T questionnaire will be filled out before surgery and on day 1, 2, 7, 28 after surgery; The EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaire will be filled out before surgery and on day 7, 28 after surgery; Type D scale-14(Taiwanese version) questionnaire will be filled out before surgery and on day 28 after surgery. Data will be analyzed by using descriptive statistics, paired t-test, Chi square test, Pearson's correlation, and the generalized estimating equation (GEE) was used to identify significant factors with QoL after operation.

Anticipated achievement: The anticipated achievement of this study is to provide healthcare providers with more knowledge about CRF, and help them to enhance the quality of life on gastric cancer patients in the future.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

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

入选标准

  • Clinical diagnosis of gastric cancer and schedule for major abdominal surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2

排除标准

  • Severe multiple organ impairment, comorbidities or immune disorder before surgery
  • Undergoing chemotherapy or radiotherapy

结局指标

主要结局

Fatigue

时间窗: Change from baseline fatigue at 1 month

Brief Fatigue Inventory-Taiwan Form (BFI-T). The questionnaire includes 10 items to assess fatigue.

次要结局

  • Quality of Life(Change from baseline quality of life at 1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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