Validation of Sexual Function Scale in Female Cancer

March 18, 2014 updated by: Sang-Yoon Park, National Cancer Center, Korea
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • National Cancer Center
        • Contact:
        • Principal Investigator:
          • Sang-Yoon Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

About 1130 adult women living in Korea

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sexuality
Time Frame: 2-4 weeks
2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 2, 2013

First Submitted That Met QC Criteria

March 10, 2013

First Posted (Estimate)

March 12, 2013

Study Record Updates

Last Update Posted (Estimate)

March 20, 2014

Last Update Submitted That Met QC Criteria

March 18, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • NCCNCS-12-685

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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