An Epidemiological Survey of Cancer-related Fatigue Among... | NCT04024098

Studies
An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic Cancer Patients

NCT04024098

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Oct 14, 2020Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Fatigue

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2019Actual

Primary Completion Date

Aug 31, 2020Actual

Completion Date

Aug 31, 2020Actual

First Submitted Date

Jul 8, 2019

First Submission Date that Met QC Criteria

Jul 16, 2019

First Posted Date

Jul 18, 2019Actual

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

Oct 13, 2020

Last Update Posted Date

Oct 14, 2020Actual

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

This study aim is to examine the prevalence, severity, and management of CRF among Taiwanese gynecologic cancer patients.

Detailed Description

The cross-sectional survey is conducted at oncology inpatients unit and outpatients clinics of hospitals in Taiwan. Furthermore, the results will elucidate not only the epidemiology of CRF in Taiwan, but will supply physicians with more understanding about CRF, and help them to enhance the quality on cancer care to being perfected in the future.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cancer-related fatigue evaluation-1	ICD-10 Fatigue Criteria	10 minuts
Cancer-related fatigue evaluation-2	Brief Fatigue Inventory-Taiwan Form (BFI-T)	8 minuts
Symptoms and Quality of Life Assessments-1	Functional Assessment of Cancer Therapy-General quality of life questionnaire (FACT-G7)	4 minuts
Symptoms and Quality of Life Assessments-2	cancer symptom survey (self-designed questionnaire)	5 minuts

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who signed the informed consent form
The age of eligible patients should be ≥ 20 years old.
Inpatients or outpatients who have been given a diagnosis of gynecologic cancer.
Able to communicate verbally and completely fill out the questionnaires

Exclusion Criteria:

Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

gynecologic cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CHING-CHOU TSAI, Dr.	Kaohsiung Chan Gung Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Chan Gung Memorial Hospital		Kaohsiung City			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D005221	Fatigue

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided