Clinical trial NCT03766945: Fatigue and QoL Among Gastric Cancer Patients Undergoing Abdominal Surgery
Official title: A Survey of Fatigue and QoL Among Gastric Cancer Patients Undergoing Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Surgical Wound Infection
Fatigue
Quality of Life
Keywords: Gastric Cancer
Surgery
Fatigue
Quality of Life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Gastric cancer patients who are scheduled for major abdominal surgery will be enrolled.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fatigue
timeFrame: Change from baseline fatigue at 1 month
Secondary outcomes:
measure: Quality of Life
timeFrame: Change from baseline quality of life at 1 month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jin-Ming Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: