FatigueNCT04024098
An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic Cancer Patients
An observational study of Fatigue, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aim is to examine the prevalence, severity, and management of CRF among Taiwanese gynecologic cancer patients. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Fatigue
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jul 2019to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: gynecologic cancer patients
Who may be able to join
- 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
Who cannot join
- Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic
This study aim is to examine the prevalence, severity, and management of CRF among Taiwanese gynecologic cancer patients.
Read the 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.
- Conditions
- Fatigue
- Medical subject headings
- Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-related fatigue evaluation-1
ICD-10 Fatigue Criteria
Measured: 10 minuts
Cancer-related fatigue evaluation-2
Brief Fatigue Inventory-Taiwan Form (BFI-T)
Measured: 8 minuts
Symptoms and Quality of Life Assessments-1
Functional Assessment of Cancer Therapy-General quality of life questionnaire (FACT-G7)
Measured: 4 minuts
Symptoms and Quality of Life Assessments-2
cancer symptom survey (self-designed questionnaire)
Measured: 5 minuts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start11 Jul 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHING-CHOU TSAI, Chang Gung Memorial Hospital
- Investigators
- CHING-CHOU TSAI, Dr., Principal investigator, Kaohsiung Chan Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024098
- Sponsor's protocol ID
- CRF-CGMH01
- Status last verified
- Oct 2020
- First submitted
- 8 Jul 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic
- ClinicalTrials.gov ID
- NCT04024098
- Acronym / sponsor ID
- CRF-CGMH01
- Conditions
- Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- gynecologic cancer patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHING-CHOU TSAI, Dr. principal investigator
Kaohsiung Chan Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-related fatigue evaluation-1 (time frame: 10 minuts). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.