Spots Global Cancer Trial Database for Evaluating Sexual Function in Women Undergoing a Radical Cystectomy for Bladder Cancer
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Trial Identification
Brief Title: Evaluating Sexual Function in Women Undergoing a Radical Cystectomy for Bladder Cancer
Official Title: Sexual Function in Women After Radical Cystectomy
Study ID: NCT05399004
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Sibley Memorial Hospital, Washington, District of Columbia, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Louisiana State University, Lafayette, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Albany Medical Center, Albany, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
M D Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
Contact Details
Name: Stephen A Boorjian
Affiliation: Mayo Clinic in Rochester
Role: PRINCIPAL_INVESTIGATOR
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