SexualityNCT01809405
Validation of Sexual Function Scale in Female Cancer
An observational study of Sexuality and Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual Function(QSF) version in Korean language of the cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexuality, Cancer, Healthy Women
- How many people
- 1,130 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Dec 2016
- How long will I take part?
- 3 Weeks
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: About 1130 adult women living in Korea
Who may be able to join
- Healthy women
- Female without history of cancer
- Cancer free as of the most recent linkage
- At least 18 years of age
- Able to speak and read Korean
- Sexual activity within 3months.
Show all 11Show fewer
- Female cancer patient
- History of gynecological or breast cancer
- At least 18 years of age
- Able to speak and read Korean
- Sexual activity within 3months.
Who cannot join
- Women who are unable to complete the questionnaires.
- Refuse to participate in the survey.
Trial locations and contacts
1 site in 1 country.
Sang-Yoon Park contact
Myong Cheol Lim contact
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do
irb, irb@ncc.re.kr
Sang-Yoon Park
About this study
To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual Function(QSF) version in Korean language of the cancer patients.
Read the detailed description
Due to the observational nature of the study which aims to evaluate the internal consistency and validity of the Korean version of Questionnaire, formal sample size and power calculations were not performed. When the number of observations (items) per subject ranges from 4 to 6, roughly 152-199 patients are required to show 10% increase in intraclass correlation from baseline ICC of 30% with 85% power and 5% type I error rate. The sample size was determined based on this calculation and practical considerations.
The pilot study will be performed based on 30 people (include reference), and the main study will include 1100 people (considering 10% drop-out from 200 people in each group) cancer type (ovary, cervix, endometrium, and breast) and healthy female. Total 1130 patients.
- Conditions
- Sexuality, Cancer, Healthy Women
- Medical subject headings
- Sexuality, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
sexuality
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2014
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SexualityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,130 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sang-Yoon Park, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809405
- Sponsor's protocol ID
- NCCNCS-12-685
- Status last verified
- Mar 2014
- First submitted
- 2 Mar 2013
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Sexual Function Scale in Female Cancer
- ClinicalTrials.gov ID
- NCT01809405
- Acronym / sponsor ID
- NCCNCS-12-685
- Conditions
- Sexuality, Cancer, Healthy Women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,130 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Dec 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Mar 2013 (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 validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual Function(QSF) version in Korean language of the cancer patients.
Detailed description
Due to the observational nature of the study which aims to evaluate the internal consistency and validity of the Korean version of Questionnaire, formal sample size and power calculations were not performed. When the number of observations (items) per subject ranges from 4 to 6, roughly 152-199 patients are required to show 10% increase in intraclass correlation from baseline ICC of 30% with 85% power and 5% type I error rate. The sample size was determined based on this calculation and practical considerations.
The pilot study will be performed based on 30 people (include reference), and the main study will include 1100 people (considering 10% drop-out from 200 people in each group) cancer type (ovary, cervix, endometrium, and breast) and healthy female. Total 1130 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- About 1130 adult women living in Korea
Key inclusion criteria (11 listed)
- Healthy women
- Female cancer patient
Key exclusion criteria (2 listed)
- Women who are unable to complete the questionnaires.
- Refuse to participate in the survey.
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
sexuality
Time frame: 2-4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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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.
Sang-Yoon Park contact
Myong Cheol Lim contact
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 Sexuality and Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 11 inclusion and 2 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 20 Mar 2014. 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 South Korea. 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 Sang-Yoon Park (parksang@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexuality (time frame: 2-4 weeks). 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 20 Mar 2014.