This phase II trial studies how well surgery works in preventing ovarian cancer in patients with genetic mutations at risk of ovarian cancer. Risk reducing salpingo oophorectomy (RRSO) is surgery to remove the fallopian tubes and ovaries at the same time. Interval salpingectomy with delayed oophorectomy (ISDO) is surgery to remove the fallopian tubes. It is not known whether ISDO works better than RRSO at lowering risk of ovarian cancer and improving the sexual function and psychosocial well-being in patients with genetic mutation.
Primary Objectives: 1\. To examine changes in female sexual function with the strategy of interval salpingectomy and delayed oophorectomy (ISDO) compared to the strategy of risk-reducing salpingo-oophorectomy (RRSO) for patients who carry genetic mutations that predispose them to ovarian cancer. Secondary Objectives: 1. To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO. 2. To estimate quality of life with ISDO compared to RRSO. 3. To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures. 4. To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality. 5. To determine the compliance with delayed oophorectomy within the ISDO arm. 6. To estimate the number of fallopian tube, ovarian, primary peritoneal malignancies and other malignancies over the course of the study. 7. To identify common themes regarding influential factors in the decision to undergo risk reducing surgery in premenopausal women at genetic high-risk for ovarian can OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients undergo ISDO. ARM II: Patients undergo RRSO. After completion of study treatment, patients are followed up at 1 and 6 months, 1 year, and 2 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
374
Correlative studies
Undergo ISDO
Ancillary studies
Undergo ISDO
Undergo RRSO
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Siteman Cancer Center at Washington University
St Louis, Missouri, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
M D Anderson Cancer Center
Houston, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Percent of women with clinically meaningful change in the Female Sexual Function Index (FSFI) score
Will be calculated using the Cochran-Mantel-Haenszel test stratified by age, with 5-year age groups. We will use propensity score methods to account for potential differences between interval salpingectomy with delayed oophorectomy (ISDO) and risk-reducing bilateral salpingectomy with oophorectomy (RRSO) arms with respect to age, baseline survey scores, and other potential confounders, and we will use the propensity scores as inverse weights in logistic regression to model the logit of the probability of having a clinically meaningful change in FSFI score from baseline to 6 months as our primary analysis.
Time frame: From baseline to 6 months
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