Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-26 @ 8:59 AM
Study NCT ID:
NCT00053261
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2003-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Changes and Sexual Function in Patients With Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D019529', 'term': 'Sexuality'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-06', 'lastUpdateSubmitDate': '2013-05-24', 'studyFirstSubmitDate': '2003-01-27', 'studyFirstSubmitQcDate': '2003-01-27', 'lastUpdatePostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['sexuality and reproductive issues', 'stage IB cervical cancer'], 'conditions': ['Cervical Cancer', 'Sexuality and Reproductive Issues']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Vaginal changes that may effect sexual function occur in patients undergoing treatment for cervical cancer.\n\nPURPOSE: Clinical trial to determine the type of vaginal changes such as vaginal dryness that occur in patients receiving treatment for cervical cancer and the effect these changes have on sexual function.', 'detailedDescription': 'OBJECTIVES:\n\n* Obtain estimates of changes in vaginal length, perceived vaginal elasticity, perceived vaginal lubrication, and sexual activity, response, and satisfaction among patients with stage IB2 cervical cancer.\n* Compare these differences between the patients in the two treatment groups in GOG-0201.\n* Determine the relationships between vaginal dilation activities and vaginal length changes in these patients.\n* Determine the association between smoking and vaginal length and between smoking and vaginal dryness in these patients after therapy for cervical cancer.\n* Assess the extent of subject interest in and preferred methods of sexual counseling related to problems resulting from treatment in these patients.\n\nOUTLINE: Vaginal length is measured using Vaginal Sound, a modified plastic vaginal dilator. The data about vaginal elasticity and lubrication and sexual activity, response, and satisfaction are obtained from patient self-report, as well as vaginal dilation activities. Measurement and assessments are taken before treatment and then at 3, 6, 12, and 24 months.\n\nPatients are followed every 3 months for 2 years.\n\nPROJECTED ACCRUAL: Approximately 150 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Entered and treated on GOG-0201 or eligible for and treated on either arm of GOG-0201\n\n * May have refused entry on GOG-0201 as long as treatment is prescribed according to one or the other arm\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Under 70\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00053261', 'briefTitle': 'Vaginal Changes and Sexual Function in Patients With Cervical Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'Vaginal Length, Elasticity, Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma', 'orgStudyIdInfo': {'id': 'CDR0000269327'}, 'secondaryIdInfos': [{'id': 'GOG-8003'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'management of therapy complications', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31403', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bronson Methodist Hospital', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'West Michigan Cancer Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '49001', 'city': 'Kalamazooaa', 'state': 'Michigan', 'country': 'United States', 'facility': 'Borgess Medical Center'}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ellis Fischel Cancer Center at University of Missouri - Columbia', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Cancer Center at Stony Brook University Hospital', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University Hospital', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma University Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates - Midtown Tulsa', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Memorial Hospital', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '18105', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}], 'overallOfficials': [{'name': 'Deborah Watkins Bruner, RN, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fox Chase Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}