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出境医 / 临床实验 / An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic Cancer Patients

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

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

Condition or disease
Fatigue

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.
Study Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic
Actual Study Start Date : July 11, 2019
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Cancer-related fatigue evaluation-1 [ Time Frame: 10 minuts ]
    ICD-10 Fatigue Criteria

  2. Cancer-related fatigue evaluation-2 [ Time Frame: 8 minuts ]
    Brief Fatigue Inventory-Taiwan Form (BFI-T)

  3. Symptoms and Quality of Life Assessments-1 [ Time Frame: 4 minuts ]
    Functional Assessment of Cancer Therapy-General quality of life questionnaire (FACT-G7)

  4. Symptoms and Quality of Life Assessments-2 [ Time Frame: 5 minuts ]
    cancer symptom survey (self-designed questionnaire)


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
gynecologic cancer patients
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
Contacts and Locations

Locations
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Taiwan
Kaohsiung Chan Gung Memorial Hospital
Kaohsiung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: CHING-CHOU TSAI, Dr. Kaohsiung Chan Gung Memorial Hospital
Tracking Information
First Submitted Date July 8, 2019
First Posted Date July 18, 2019
Last Update Posted Date October 14, 2020
Actual Study Start Date July 11, 2019
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
  • Cancer-related fatigue evaluation-1 [ Time Frame: 10 minuts ]
    ICD-10 Fatigue Criteria
  • Cancer-related fatigue evaluation-2 [ Time Frame: 8 minuts ]
    Brief Fatigue Inventory-Taiwan Form (BFI-T)
  • Symptoms and Quality of Life Assessments-1 [ Time Frame: 4 minuts ]
    Functional Assessment of Cancer Therapy-General quality of life questionnaire (FACT-G7)
  • Symptoms and Quality of Life Assessments-2 [ Time Frame: 5 minuts ]
    cancer symptom survey (self-designed questionnaire)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic Cancer Patients
Official Title An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population gynecologic cancer patients
Condition Fatigue
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 16, 2019)
200
Original Estimated Enrollment Same as current
Actual Study Completion Date August 31, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04024098
Other Study ID Numbers CRF-CGMH01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party CHING-CHOU TSAI, Chang Gung Memorial Hospital
Study Sponsor Chang Gung Memorial Hospital
Collaborators Not Provided
Investigators
Principal Investigator: CHING-CHOU TSAI, Dr. Kaohsiung Chan Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date October 2020