Fatigue and QoL Among Gastric Cancer Patients Undergoing Abdominal Surgery

NCT ID: NCT03766945

Last Updated: 2018-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-27

Study Completion Date

2019-07-25

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Surgical Wound Infection Fatigue Quality of Life

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jin-Ming Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jin-Ming Wu, PhD

Role: CONTACT

+886-972652080

Shiow-Ching Shun, PhD

Role: CONTACT

+886-2-23123456 ext. 88439

Facility Contacts

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Hui-Ting Yang, MSN

Role: primary

+886930005267

Other Identifiers

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201705112RINB

Identifier Type: -

Identifier Source: org_study_id

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