Validation of Sexual Function Scale in Female Cancer
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|ClinicalTrials.gov Identifier: NCT01809405|
Recruitment Status : Unknown
Verified March 2014 by Sang-Yoon Park, National Cancer Center, Korea.
Recruitment status was: Recruiting
First Posted : March 12, 2013
Last Update Posted : March 20, 2014
|Condition or disease|
|Sexuality Cancer Healthy Women|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1130 participants|
|Target Follow-Up Duration:||3 Weeks|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||December 2016|
- sexuality [ Time Frame: 2-4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809405
|Contact: Sang-Yoon Parkfirstname.lastname@example.org|
|Contact: Myong Cheol Limemail@example.com|
|Korea, Republic of|
|National Cancer Center||Recruiting|
|Goyang, Gyeonggi-do, Korea, Republic of|
|Contact: irb firstname.lastname@example.org|
|Principal Investigator: Sang-Yoon Park|