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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03766945
Other study ID # 201705112RINB
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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