Fatigue and QoL Among Gastric Cancer Patients Undergoing Abdominal Surgery

• Conditions: Surgical Wound Infection; Quality of Life; Gastric Cancer; Fatigue

• Registration Number: NCT03766945
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-27
• Status Verified: 2018-06
• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-12-04
• Last Update Submitted: 2018-12-04
• Study First Posted: 2018-12-06
• Last Update Posted: 2018-12-06
• Primary Completion: 2019-07-25
• Study Completion: 2019-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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Exclusion Criteria

1. Severe multiple organ impairment, comorbidities or immune disorder before surgery
2. Undergoing chemotherapy or radiotherapy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue	Change from baseline fatigue at 1 month	Brief Fatigue Inventory-Taiwan Form (BFI-T). The questionnaire includes 10 items to assess fatigue.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	Change from baseline quality of life at 1 month	Quality of Life Questionnaire(EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaire). The questionnaire includes 52 items to assess quality of life.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan