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Validation of Sexual Function Scale in Female Cancer

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Unknown status
CT.gov ID
NCT01809405
Collaborator
(none)
1,130
Enrollment
1
Location
48
Duration (Months)
23.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1130 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Dec 1, 2012
    Actual Primary Completion Date :
    Feb 1, 2014
    Anticipated Study Completion Date :
    Dec 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. sexuality [2-4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center Goyang Gyeonggi-do Korea, Republic of

    Sponsors and Collaborators

    • National Cancer Center, Korea

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sang-Yoon Park, Senior researcher, National Cancer Center, Korea
    ClinicalTrials.gov Identifier:
    NCT01809405
    Other Study ID Numbers:
    • NCCNCS-12-685
    First Posted:
    Mar 12, 2013
    Last Update Posted:
    Mar 20, 2014
    Last Verified:
    Mar 1, 2014

    Study Results

    No Results Posted as of Mar 20, 2014