Validation of Sexual Function Scale in Female Cancer

Status Unknown status

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01809405
Study type	Observational [Patient Registry]
Source	National Cancer Center, Korea
Contact	Sang-Yoon Park
Email	parksang@ncc.re.kr
Status	Unknown status
Phase	N/A
Start date	December 2012
Completion date	December 2016

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