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NCT01809405 Clinical Trial

Validation of Sexual Function Scale in Female Cancer

Cancer Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01809405
Other study ID # NCCNCS-12-685
Secondary ID
Status Unknown status
Phase N/A
First received March 2, 2013
Last updated March 18, 2014
Start date December 2012
Est. completion date December 2016

Study information
Verified date March 2014
Source National Cancer Center, Korea
Contact Sang-Yoon Park
Email parksang@ncc.re.kr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 1130
Est. completion date December 2016
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- Women who are unable to complete the questionnaires.

- Refuse to participate in the survey.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of National Cancer Center Goyang Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary sexuality 2-4 weeks
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