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Fatigue and QoL Among Gastric Cancer Patients Undergoing Abdominal Surgery

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National Taiwan University

Status

Unknown

Conditions

Gastric Cancer
Quality of Life
Fatigue
Surgical Wound Infection

Study type

Observational

Funder types

Other

Identifiers

NCT03766945
201705112RINB

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial contacts and locations

1

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Central trial contact

Shiow-Ching Shun, PhD; Jin-Ming Wu, PhD

Data sourced from clinicaltrials.gov

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