Fatigue and QoL Among Gastric Cancer Patients Undergoing Abdominal Surgery
A Survey of Fatigue and QoL Among Gastric Cancer Patients Undergoing Major Abdominal Surgery
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 27, 2017
CompletedFirst Submitted
Initial submission to the registry
November 22, 2018
CompletedFirst Posted
Study publicly available on registry
December 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2019
CompletedDecember 6, 2018
June 1, 2018
2 years
November 22, 2018
December 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue
Brief Fatigue Inventory-Taiwan Form (BFI-T). The questionnaire includes 10 items to assess fatigue.
Change from baseline fatigue at 1 month
Secondary Outcomes (1)
Quality of Life
Change from baseline quality of life at 1 month
Eligibility Criteria
Gastric cancer patients who are scheduled for major abdominal surgery will be enrolled.
You may qualify if:
- Clinical diagnosis of gastric cancer and schedule for major abdominal surgery
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
You may not qualify if:
- Severe multiple organ impairment, comorbidities or immune disorder before surgery
- Undergoing chemotherapy or radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Biospecimen
Biomarkers including pre-operative and post-operative serum IFN-gamma, IL-1 beta, IL-4, IL-6, IL-10 and TNF.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Ming Wu, PhD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2018
First Posted
December 6, 2018
Study Start
July 27, 2017
Primary Completion
July 25, 2019
Study Completion
July 25, 2019
Last Updated
December 6, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share