Fatigue and QoL Among Gastric Cancer Patients Undergoing... | NCT03766945

Studies
Fatigue and QoL Among Gastric Cancer Patients Undergoing Abdominal Surgery

NCT03766945

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Dec 6, 2018Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Gastric Cancer
Surgical Wound Infection
Fatigue
Quality of Life

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2017Actual

Primary Completion Date

Jul 25, 2019Estimated

Completion Date

Jul 25, 2019Estimated

First Submitted Date

Nov 22, 2018

First Submission Date that Met QC Criteria

Dec 4, 2018

First Posted Date

Dec 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2018

Last Update Posted Date

Dec 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of gastric cancer and schedule for major abdominal surgery
Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Exclusion Criteria:

Severe multiple organ impairment, comorbidities or immune disorder before surgery
Undergoing chemotherapy or radiotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Gastric cancer patients who are scheduled for major abdominal surgery will be enrolled.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin-Ming Wu, PhD	Contact	+886-972652080		wujm0531@gmail.com
Shiow-Ching Shun, PhD	Contact	+886-2-23123456	88439	scshun@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Jin-Ming Wu, PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D013530	Surgical Wound Infection
D005221	Fatigue

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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Browse Branches

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