Fatigue and QoL Among Gastric Cancer Patients Undergoing Abdominal Surgery

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03766945
• Other study ID #: 201705112RINB
• Status: Recruiting
• Start date: July 27, 2017
• Est. completion date: July 25, 2019

Study information

• Verified date: June 2018
• Source: National Taiwan University Hospital
• Contact: Jin-Ming Wu, PhD
• Phone: +886-972652080
• Email: wujm0531[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 25, 2019
• Est. primary completion date: July 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Gastric Cancer
• Quality of Life
• Stomach Neoplasms
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Brief Fatigue Inventory-Taiwan Form (BFI-T). The questionnaire includes 10 items to assess fatigue.	Change from baseline fatigue at 1 month
Secondary	Quality of Life	Quality of Life Questionnaire(EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaire). The questionnaire includes 52 items to assess quality of life.	Change from baseline quality of life at 1 month