Cervical CancerNCT01187706
A Controlled Study of Quality of Life and it's Related Factors Among Gynecological Cancer Survivors
An observational study of Cervical Cancer and Ovarian Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To compare quality of life and it's related factors between gynecological cancer survivor and healthy controls. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Ovarian Cancer, Endometrial Cancer
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to not given
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study used a cross-sectional design. By using the method of purposive sampling, the 70 gynecological cancer patients who had completed the active treatments for six months will be recruited from the oncology and gynecology clinics of a medical center in the Northern Taiwan area. The 70 healthy controls without any cancer will be recruited from clinic and from friends and colleagues.
Who may be able to join
- Been diagnosed as cervical cancer, ovarian cancer or endometrial cancer, and has completed six months after the relevant treatment.
- 20-70 years old
- Agreed to participate in this study.
Who cannot join
- Combined with other non-gynecologic cancer (cervical cancer, ovarian cancer or endometrial cancer) patients.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Fei-Hsiu Hsiao, Ph.D., +886-2-23123456 ext. 88432, hsiaofei@ntu.edu.tw
About this study
To compare quality of life and it's related factors between gynecological cancer survivor and healthy controls.
Read the detailed description
This study used a cross-sectional design. By using the method of purposive sampling, the 70 gynecological cancer patients who had completed the active treatments for six months will be recruited from the oncology and gynecology clinics of a medical center in the Northern Taiwan area. The 70 healthy controls without any cancer will be recruited from clinic and from friends and colleagues. The instruments include "Sample characteristics questionnaire," "Short Form-12 (SF-12)," "Medical Outcome Study Sleep Scale (MOS-sleep)," "Beck Depression Inventory-II (BDI)," "State-Trait Anxiety Inventory (STAI)," "Sexual Activity Questionnaire (SAQ), and "The Experiences in Close Relationships-Revised (ECR-R)." The data will be analyzed by descriptive statistical analysis, independent t-test, ANOVA, Scheffe's test, Pearson's correlation, and stepwise regression.
- Conditions
- Cervical Cancer, Ovarian Cancer, Endometrial Cancer
- Keywords
- gynecological cancer survivors, quality of life
- Medical subject headings
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| gynecological cancer survivors | Criteria for including: (1)Been diagnosed as cervical cancer, ovarian cancer or endometrial cancer, and has completed six months after the relevant treatment. (2)Age from 20 - 70 years old. (3) Agreed to participate in this study. Criteria for exclusion: Combined with other non-gynecologic cancer (cervical cancer, ovarian cancer or endometrial cancer) patients. | |
| healthy controls | Criteria for including: (1)Not those who suffer from cancer.(2)20-70 years old.(3)Agreed to participate in this study.Criteria for exclusion:Had undergone gynecologic surgical removal of ovaries or uterus were. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Fei-Hsiu Hsiao, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187706
- Sponsor's protocol ID
- 201007087R
- Status last verified
- Aug 2010
- First submitted
- 23 Aug 2010
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study of Quality of Life and it's Related Factors Among Gynecological Cancer Survivors
- ClinicalTrials.gov ID
- NCT01187706
- Acronym / sponsor ID
- 201007087R
- Conditions
- Cervical Cancer, Ovarian Cancer, Endometrial Cancer
- Keywords
- gynecological cancer survivors, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- First posted
- 24 Aug 2010 (estimated)
- 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.
To compare quality of life and it's related factors between gynecological cancer survivor and healthy controls.
Detailed description
This study used a cross-sectional design. By using the method of purposive sampling, the 70 gynecological cancer patients who had completed the active treatments for six months will be recruited from the oncology and gynecology clinics of a medical center in the Northern Taiwan area. The 70 healthy controls without any cancer will be recruited from clinic and from friends and colleagues. The instruments include "Sample characteristics questionnaire," "Short Form-12 (SF-12)," "Medical Outcome Study Sleep Scale (MOS-sleep)," "Beck Depression Inventory-II (BDI)," "State-Trait Anxiety Inventory (STAI)," "Sexual Activity Questionnaire (SAQ), and "The Experiences in Close Relationships-Revised (ECR-R)." The data will be analyzed by descriptive statistical analysis, independent t-test, ANOVA, Scheffe's test, Pearson's correlation, and stepwise regression.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gynecological cancer survivors | – | –Criteria for including: (1)Been diagnosed as cervical cancer, ovarian cancer or endometrial cancer, and has completed six months after the relevant treatment. (2)Age from 20 - 70 years old. (3) Agreed to participate in this study. Criteria for exclusion: Combined with other non-gynecologic cancer (cervical cancer, ovarian cancer or endometrial cancer) patients. |
| healthy controls | – | –Criteria for including: (1)Not those who suffer from cancer.(2)20-70 years old.(3)Agreed to participate in this study.Criteria for exclusion:Had undergone gynecologic surgical removal of ovaries or uterus were. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study used a cross-sectional design. By using the method of purposive sampling, the 70 gynecological cancer patients who had completed the active treatments for six months will be recruited from the oncology and gynecology clinics of a medical center in the Northern Taiwan area. The 70 healthy controls without any cancer will be recruited from clinic and from friends and colleagues.
Key inclusion criteria (3 listed)
- Been diagnosed as cervical cancer, ovarian cancer or endometrial cancer, and has completed six months after the relevant treatment.
- 20-70 years old
- Agreed to participate in this study.
Key exclusion criteria (1 listed)
- Combined with other non-gynecologic cancer (cervical cancer, ovarian cancer or endometrial cancer) patients.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2010.
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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.
Fei-Hsiu Hsiao, Ph.D principal investigator
National Taiwan University 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 Cervical Cancer and Ovarian Cancer, run by National Taiwan University 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 3 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: status not confirmed, as of the sponsor's last update on 24 Aug 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei-Hsiu Hsiao, Ph.D. (+886-2-23123456 ext. 88432, hsiaofei@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 24 Aug 2010.