Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT01809405
Status:
UNKNOWN
Last Update Posted:
2014-03-20
First Post:
2013-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Sexual Function Scale in Female Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-09-30', 'releaseDate': '2014-09-24'}, {'resetDate': '2014-10-07', 'releaseDate': '2014-10-02'}], 'estimatedResultsFirstSubmitDate': '2014-09-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1130}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-18', 'studyFirstSubmitDate': '2013-03-02', 'studyFirstSubmitQcDate': '2013-03-10', 'lastUpdatePostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sexuality', 'timeFrame': '2-4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sexuality', 'Cancer', 'Healthy Women']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'About 1130 adult women living in Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women\n\n * Female without history of cancer\n * Cancer free as of the most recent linkage\n * At least 18 years of age\n * Able to speak and read Korean\n * Sexual activity within 3months.\n* Female cancer patient\n\n * History of gynecological or breast cancer\n * At least 18 years of age\n * Able to speak and read Korean\n * Sexual activity within 3months.\n\nExclusion Criteria:\n\n* Women who are unable to complete the questionnaires.\n* Refuse to participate in the survey.'}, 'identificationModule': {'nctId': 'NCT01809405', 'briefTitle': 'Validation of Sexual Function Scale in Female Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'orgStudyIdInfo': {'id': 'NCCNCS-12-685'}}, 'contactsLocationsModule': {'locations': [{'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'irb', 'role': 'CONTACT', 'email': 'irb@ncc.re.kr'}, {'name': 'Sang-Yoon Park', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'centralContacts': [{'name': 'Sang-Yoon Park', 'role': 'CONTACT', 'email': 'parksang@ncc.re.kr'}, {'name': 'Myong Cheol Lim', 'role': 'CONTACT', 'email': 'mclim@ncc.re.kr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior researcher', 'investigatorFullName': 'Sang-Yoon Park', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-09-24', 'type': 'RELEASE'}, {'date': '2014-09-30', 'type': 'RESET'}, {'date': '2014-10-02', 'type': 'RELEASE'}, {'date': '2014-10-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sang-Yoon Park, Senior researcher, National Cancer Center, Korea'}}}}