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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
Sponsor:
Information provided by (Responsible Party):
Sang-Yoon Park, National Cancer Center, Korea

Brief 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.

Condition or disease
Sexuality Cancer Healthy Women

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1130 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Study Start Date : December 2012
Actual Primary Completion Date : February 2014
Estimated Study Completion Date : December 2016



Primary Outcome Measures :
  1. sexuality [ Time Frame: 2-4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
About 1130 adult women living in Korea
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Sang-Yoon Park parksang@ncc.re.kr
Contact: Myong Cheol Lim mclim@ncc.re.kr

Locations
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Korea, Republic of
National Cancer Center Recruiting
Goyang, Gyeonggi-do, Korea, Republic of
Contact: irb       irb@ncc.re.kr   
Principal Investigator: Sang-Yoon Park         
Sponsors and Collaborators
National Cancer Center, Korea

Additional Information:

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Responsible Party: Sang-Yoon Park, Senior researcher, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01809405     History of Changes
Other Study ID Numbers: NCCNCS-12-685
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014