Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-30 @ 10:20 AM
Study NCT ID:
NCT00003794
Status:
TERMINATED
Last Update Posted:
2013-06-10
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality-of-Life Study of Patients With Previously Treated Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL'}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1999-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'lastUpdateSubmitDate': '2013-06-07', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-10-28', 'lastUpdatePostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage I ovarian germ cell tumor', 'stage II ovarian germ cell tumor', 'stage III ovarian germ cell tumor', 'stage IV ovarian germ cell tumor', 'recurrent ovarian germ cell tumor'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '19042263', 'type': 'RESULT', 'citation': 'Monahan PO, Champion VL, Zhao Q, Miller AM, Gershenson D, Williams SD, Cella D. Case-control comparison of quality of life in long-term ovarian germ cell tumor survivors: a gynecologic oncology group study. J Psychosoc Oncol. 2008;26(3):19-42. doi: 10.1080/07347330802115715.'}, {'type': 'RESULT', 'citation': 'Williams SD, Miller AM, Cella D, et al.: Relationship issues and sexual functioning in ovarian germ cell cancer survivors. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-845, 2001.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Quality-of-life assessment of patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment in patients with cancer.\n\nPURPOSE: This clinical trial studies the quality of life in patients with previously treated ovarian cancer.', 'detailedDescription': 'OBJECTIVES: I. Compare quality of life in terms of health status, sexual functioning, psychological/emotional well being, and social functioning in ovarian germ cell cancer survivors vs a matched healthy control group. II. Predict quality of life in these patients through the additive effects of cancer diagnosis and treatment, sociodemographic characteristics, other stressors, and social network variables.\n\nOUTLINE: Patients identify up to 3 healthy acquaintance controls within 3 years of the same age. Patients and controls complete a written questionnaire, which takes about 30 minutes, and a telephone interview, which takes about 1 hour, to assess quality of life.\n\nPROJECTED ACCRUAL: A total of 190 patients and 190 healthy controls will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: History of early or advanced ovarian germ cell tumors Continuously disease free for at least 2 years prior to study Must have been enrolled on GOG protocols 45, 78, 90, and 116 or similar protocols of cisplatin-based chemotherapy at M.D. Anderson Cancer Center\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must be able to complete a written questionnaire and telephone interview in English\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified'}, 'identificationModule': {'nctId': 'NCT00003794', 'briefTitle': 'Quality-of-Life Study of Patients With Previously Treated Ovarian Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'Quality of Life in Ovarian Germ Cell Cancer Survivors', 'orgStudyIdInfo': {'id': 'CDR0000066937'}, 'secondaryIdInfos': [{'id': 'GOG-9901'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'psychosocial assessment and care', 'type': 'PROCEDURE'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Northwestern Health Care', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46202-5289', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Stephen D. Williams, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Indiana University Melvin and Bren Simon Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}