NCT01809405

Validation of Sexual Function Scale in Female Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,130 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-02-01
• Completion: 2016-12-01
• First posted: 2013-03-12
• Last updated: 2014-03-20

Locations

1 site across 1 country: South Korea