Cancer Clinical Trial
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.
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.
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