Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT01031602
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2009-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Sexual Dysfunction, Depression and Anxiety in Underserved, Minority Gynecologic Cancers Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-24', 'studyFirstSubmitDate': '2009-12-10', 'studyFirstSubmitQcDate': '2009-12-11', 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Sexual Dysfunction, Depression, and Anxiety in Patients Surveyed', 'timeFrame': 'Survey perfomed at single point in time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Gynecology', 'Sexual Dysfunction', 'Depression', 'Anxiety', 'Underserved', 'Minority', 'Psychological distress'], 'conditions': ['Gynecologic Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': 'Objectives:\n\n* Assess the prevalence and severity of depression and anxiety in underserved and minority women seen in the gynecologic oncology clinic at Lyndon Baines Johnson General Hospital.\n* Assess the prevalence and severity of sexual dysfunction in this patient population.', 'detailedDescription': 'The instruments used in this study will be completed at one timepoint, by those women who choose to participate, anonymously. The questionnaires will be preceded with a statement informing the patient that by completing the study questionnaires she is consenting to study participation. No patient names or medical record numbers will be documented.\n\nWhen a patient checks in for her clinic appointment, she will receive a packet of study materials consisting of a cover letter describing the study objectives, the Female Sexual Function Index, the Hospital Anxiety and Depression Scale, and a demographic questionnaire. The tools used in this study will be available in both English and Spanish.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women seen at the Gynecologic Oncology Clinic at the Lyndon Baines Johnson (LBJ) General Hospital and able to read and write either English or Spanish.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Women seen at the Gynecologic Oncology Clinic at the Lyndon Baines Johnson General Hospital. The women must be able to read and write either English or Spanish.\n\nExclusion Criteria:\n\n\\- Women who are unable to complete the questionnaires.'}, 'identificationModule': {'nctId': 'NCT01031602', 'briefTitle': 'Assessment of Sexual Dysfunction, Depression and Anxiety in Underserved, Minority Gynecologic Cancers Patients', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Assessment of the Prevalence of Sexual Dysfunction, Depression, and Anxiety in Underserved and Minority Patients With Gynecologic Cancers', 'orgStudyIdInfo': {'id': '2006-0436'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Psych Needs Assessment', 'description': 'Female Sexual Function Index (FSFI), Hospital Anxiety and Depression Scale (HADS), and a demographic questionnaire given to underserved and minority women with a gynecologic cancer or premalignant condition.', 'interventionNames': ['Behavioral: Surveys']}], 'interventions': [{'name': 'Surveys', 'type': 'BEHAVIORAL', 'otherNames': ['Questionnaire'], 'description': 'Surveys -- Female Sexual Function Index (FSFI), the Hospital Anxiety and Depression Scale (HADS), and a demographic questionnaire completed at time of clinic appointment, taking about 20 minutes.', 'armGroupLabels': ['Psych Needs Assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Lyndon B. Johnson (LBJ) General Hosptial', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Lois M. Ramondetta, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UT MD Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}