NCT04024098

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

July 11, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

July 8, 2019

Last Update Submit

October 13, 2020

Conditions

Fatigue

Outcome Measures

Primary Outcomes (4)

  • 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

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

gynecologic cancer patients

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chan Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • CHING-CHOU TSAI, Dr.

    Kaohsiung Chan Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 18, 2019

Study Start

July 11, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

TW(1)