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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-13603 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
PRIMARY OBJECTIVES:
I. To characterize pre-operative sexual function and interest in sexual activity of women undergoing radical cystectomy.
II. To identify patient understanding and expectations as they relate to sexual dysfunction after radical cystectomy.
III. To describe pre-operative importance in sexual function recovery after radical cystectomy.
IV. Quantify the changes in sexual function within the year following radical cystectomy in women.
V. 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.
VI. 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.
VII. Quantify the changes in sexual activity interest within the year following radical cystectomy.
OUTLINE:
Patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (survey) | Patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey Administration | Other | Complete surveys |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative sexual function | 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. | Baseline |
| Interest in sexual activity | 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. | From baseline to 3, 6, and 12 months |
| Lubrication | 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. | From baseline to 3, 6, and 12 months |
| Vaginal discomfort | 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. | From baseline to 3, 6, and 12 months |
| Satisfaction with sex life | 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. | From baseline to 3, 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Labial discomfort | 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. | From baseline to 3, 6, and 12 months |
| Clitoral discomfort |
| Measure | Description | Time Frame |
|---|---|---|
| Physical function | 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. | From baseline to 3, 6, and 12 months |
| Fatigue |
Inclusion Criteria:
Exclusion Criteria:
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Female patients undergoing radical cystectomy for bladder cancer between September 1, 2019 and December 31, 2022.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen A Boorjian | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States | ||
| University of Iowa/Holden Comprehensive Cancer Center |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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. |
| From baseline to 3, 6, and 12 months |
| Orgasm ability | 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. | From baseline to 3, 6, and 12 months |
| Orgasm pleasure | 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. | From baseline to 3, 6, and 12 months |
| Change in sexual function scores | 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. | From baseline to 12 months |
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.
| From baseline to 3, 6, and 12 months |
| Pain interference | 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. | From baseline to 3, 6, and 12 months |
| Depressive symptoms | 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. | From baseline to 3, 6, and 12 months |
| Anxiety | 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. | From baseline to 3, 6, and 12 months |
| Ability to participate in social roles and activities | 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. | From baseline to 3, 6, and 12 months |
| Sleep disturbances | 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. | From baseline to 3, 6, and 12 months |
| Preoperative expectations/importance of sexual function recovery | 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. | Baseline |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Louisiana State University | Lafayette | Louisiana | 70503 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
| University of Washington Medical Center - Montlake | Seattle | Washington | 98195 | United States |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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