Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-03-19 @ 2:41 PM
Study NCT ID:
NCT05399004
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Sexual Function in Women Undergoing a Radical Cystectomy for Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2022-05-26', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical function', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Fatigue', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Pain interference', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Depressive symptoms', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Anxiety', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Ability to participate in social roles and activities', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Sleep disturbances', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Preoperative expectations/importance of sexual function recovery', 'timeFrame': 'Baseline', 'description': 'Will use a linear mixed effects model of sexual function scores measured post-baseline through 12 months, adjusted for baseline sexual function score to evaluate if preoperative expectation/importance of sexual function recovery is associated with outcomes over time.'}], 'primaryOutcomes': [{'measure': 'Preoperative sexual function', 'timeFrame': 'Baseline', 'description': 'Assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Brief Profile Sexual Function and Satisfaction version 2 (v2.0). Will utilize descriptive statistics to report preoperative sexual function. Frequencies and percentages will be reported for categorical variables and mean (standard deviation) or median (interquartile range) for continuous variables.'}, {'measure': 'Interest in sexual activity', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Lubrication', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Vaginal discomfort', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Satisfaction with sex life', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}], 'secondaryOutcomes': [{'measure': 'Labial discomfort', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Clitoral discomfort', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Orgasm ability', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Orgasm pleasure', 'timeFrame': 'From baseline to 3, 6, and 12 months', 'description': 'Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.'}, {'measure': 'Change in sexual function scores', 'timeFrame': 'From baseline to 12 months', 'description': 'Will use a linear mixed effects model of 12-month sexual function scores adjusting for baseline function to evaluate independent variables of interest related to the surgical procedure: age, robotic/open approach, pelvic organ sparing and diversion type. Variables of interest will be analyzed separately. In the analysis of robotic vs. open approach, the model will include terms for time (after surgery: 3, 6, and 12 months, using a discrete time formulation), approach (robotic=1, open=0), and approach by time interaction. Contrasts of the interaction and main effects will allow estimation of whether outcomes at 12 months differ by approach.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the general physical, emotional, and sexual function in women undergoing a radical cystectomy for bladder cancer. A radical cystectomy is a surgical procedure that involves the removal of the bladder, uterus, ovaries, fallopian tubes, and part of the vagina. This may affect sexual function in women. This study seeks to understand how radical cystectomy alters sexual function and well-being, and what factors may affect this change.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To characterize pre-operative sexual function and interest in sexual activity of women undergoing radical cystectomy.\n\nII. To identify patient understanding and expectations as they relate to sexual dysfunction after radical cystectomy.\n\nIII. To describe pre-operative importance in sexual function recovery after radical cystectomy.\n\nIV. Quantify the changes in sexual function within the year following radical cystectomy in women.\n\nV. Explore the effects of age, baseline sexual function, general quality of life, parity, menopausal status, hormone replacement therapy (topical versus \\[vs.\\] oral), general and cancer related quality of life, chemotherapy (neoadjuvant vs. adjuvant), treatment-related complications and performance status on sexual function outcomes.\n\nVI. Explore the effects of robotic vs. open approach, extracorporeal vs. intracorporal approach, organ-sparing (ovaries, uterus, cervix, anterior vaginal wall), type of vaginal closure (vertical vs. horizontal), nerve sparing, urinary diversion type (ileal conduit vs. neobladder vs. continent cutaneous diversion) on sexual function outcomes.\n\nVII. Quantify the changes in sexual activity interest within the year following radical cystectomy.\n\nOUTLINE:\n\nPatients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients undergoing radical cystectomy for bladder cancer between September 1, 2019 and December 31, 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women greater than 18 years of age\n* A diagnosis of bladder cancer\n* Planned to undergo a radical cystectomy\n* Willing and able to complete survey questionnaires\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Non-English speaking\n* Life expectancy less than 2 years'}, 'identificationModule': {'nctId': 'NCT05399004', 'briefTitle': 'Evaluating Sexual Function in Women Undergoing a Radical Cystectomy for Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Sexual Function in Women After Radical Cystectomy', 'orgStudyIdInfo': {'id': '19-007376'}, 'secondaryIdInfos': [{'id': 'NCI-2021-13603', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (survey)', 'description': 'Patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months.', 'interventionNames': ['Other: Survey Administration']}], 'interventions': [{'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Complete surveys', 'armGroupLabels': ['Observational (survey)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Sibley Memorial Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa/Holden Comprehensive Cancer Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '70503', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University/Sidney Kimmel Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania/Abramson Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University/Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute/University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center - Montlake', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Stephen A Boorjian', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stephen A. Boorjian, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}