Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-01 @ 5:39 PM
Study NCT ID:
NCT04070950
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2019-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexuality of Women With Pelvic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D010386', 'term': 'Pelvic Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2010-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-26', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of sexual activity', 'timeFrame': '3 months after the end of therapeutic treatment (not the object of the study)', 'description': 'Questionnaire SAQ : Sexual Activity Questionnaire, contains 21 items divided into three parts: the first part allows to know if a woman is sexually active or not, the second part allows to define the reasons for this activity or its absence. The third part of the questionnaire filled out by sexually active women aims to explore the pleasure generated by sex (desire, satisfaction, frequency), discomfort during intercourse, especially due to vaginal dryness and pain as well as the habits of the patient before the illness.'}]}, 'conditionsModule': {'conditions': ['Sexual Behavior', 'Pelvic Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to study in patients with cancer of the cervix or the body of the uterus, or the ovary between the time of diagnosis and 3 months after the end of the last treatment: the evolution of the relationship of couple, and more particularly of communication (verbal and non-verbal) concerning sexuality, before and during cancer.', 'detailedDescription': "The representations associated with sexuality and cancer seem antinomic: wellbeing / death, and yet combine in the experience of cancer. The latter has an impact on sexuality in terms of satisfaction or sexual activity and on the relationship in terms of support.\n\nIn addition, various studies show the psychological impact of treatments on the couple's relationship or the body image of women with cancer. Their abilities to seduce are affected and explain the decrease of their sexual activity during the treatments: a communication, valuing the femininity, would it then facilitate the relations of couple? There is no work that considers sexuality in a systematic way (sexual act and verbal and non-verbal communication) and apprehends its link with the evolution of the relationship, from the diagnosis of cancer to the end of treatments.\n\nThis study aims to study in patients with cancer of the cervix or the body of the uterus, or the ovary between the time of diagnosis and 3 months after the end of the last treatment: the evolution of the relationship of couple, and more particularly of communication (verbal and non-verbal) concerning sexuality, before and during cancer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with cancer of the cervix or uterine body, or ovarian', 'genderDescription': 'Women with cancer of the cervix or uterine body, or ovarian', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Life in a couple or single with a regular partner for at least 3 months\n* Cancer of the cervix or uterine body or ovarian cancer, in first diagnosis and treatment\n* Whatever the stage of cancer\n* Curative treatment\n* Support in one of the participating centers\n* Possible follow-up of all stages of the research\n\nExclusion Criteria:\n\n* Presence of metastases\n* History of other cancer\n* History of severe psychiatric illness'}, 'identificationModule': {'nctId': 'NCT04070950', 'acronym': 'FECAPSE', 'briefTitle': 'Sexuality of Women With Pelvic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Longitudinal Study of the Couple Relationship of Women With Pelvic Cancer: Impact on Sexuality', 'orgStudyIdInfo': {'id': 'CHUBX 2008/39'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single group', 'description': 'Interview of patients with cancer of the cervix or uterine body, or ovary between the time of diagnosis and 3 months after the end of their last cancer treatment (not the object of the study).', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Two self-questionnaires', 'armGroupLabels': ['Single group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alain RAVAUD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}