NRG-CC008 A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]
Objective
Primary Objective: To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations.
Secondary Objectives: To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the FACT-ES subscale compared to pre-menopausal patients in the BSO arm. To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL) and sexual dysfunction (FSFI)in pre-menopausal patients who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from pre-menopausal BSO patients. To determine if health-related QOL (FACT) is negatively impacted by cancer distress (IES) in individuals who have undergone BLS, in comparison to BSO patients. To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice. To assess adverse events, graded using CTCAE v5.0.
