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Evaluating the Impact of an Interactive Educational Video on Opportunistic Salpingectomy for the Prevention of Ovarian Cancer
Trial Status: active
This clinical trial tests the effect of an interactive educational video on interest in having fallopian tubes removed (salpingectomy) during a non-gynecologic surgery (opportunistic) to prevent ovarian cancer and tests the the practicality of undergoing an opportunistic salpingectomy (OS) during a standard nongynecologic surgery. Ovarian cancer has no known early stage symptoms and currently there are no screening tests for ovarian cancer. Evidence suggests that the most lethal form of ovarian cancer comes from the fallopian tubes. It is recommended that high risk patients undergo removal of ovaries and fallopian tubes, however, this results in surgical menopause. Removal of fallopian tubes only may reduce the risk of ovarian cancer without the side effects related to menopause. A 3-dimensional (3D) interactive educational video about the reproductive system and the origins of ovarian cancer may be an effective method to increase knowledge and may increase the use of OS for the prevention of ovarian cancer in high risk patients. Performing salpingectomy during a scheduled nongynecologic surgical procedure may be an effective strategy to increase access to surgical prevention.
Inclusion Criteria
PART 1: Age ≥ 45 years
PART 1: Scheduled visit with a nongynecologic surgeon
PART 1: Female or assigned female at birth
PART 2: Age ≥ 45 years
PART 2: At least one in situ fallopian tube
PART 2: No desire or plan to have children in the future
PART 2: Average risk of developing ovarian cancer
* Note: Average risk patients are defined as patients with no known genetic risk factor for developing ovarian cancer. Patients who, after obtaining family history, are suspected to have a hereditary ovarian cancer syndrome but have not yet been tested, will be referred for genetic evaluation
PART 2: Planned nongynecologic, intraabdominal, or pelvic surgery
PART 2: Deemed to be a suitable candidate by gynecologic surgeon and primary nongynecologic surgeon (for example, on the basis of surgical history and current malignancy status)
PART 2: Approved and signed informed consent
Exclusion Criteria
PART 1: Not fluent in English or Spanish
* If there is a non-english or non-spanish speaking participant who is a strong candidate and meets all other criteria for Part 2, they are able to go directly onto Part 2 without completing Part 1
PART 1: Known inherited ovarian cancer susceptibility
PART 2: Personal history of a gynecologic malignancy
PART 2: Carrier of a hereditary breast or ovarian cancer variant (e.g., BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, MLH1, MSH2, MSH6, PMS2)
PART 2: Suspicious ovarian, fallopian tube, or uterine lesion on preoperative imaging
PART 2: Previous bilateral salpingectomy or bilateral salpingo-oophorectomy
PART 2: Presence of ESSURE, or other tubal-implanted birth control at the time of surgery
PART 2: Current pregnancy
PART 2: Emergent procedure or emergency procedure that has to be completed within 24 hours where clinical consent occurs in the inpatient setting or where the patient’s immediate well-being is in danger or condition may be life threatening
PART 2: Primary surgeon anticipates that OS will add significant time (> 30-40min) to the planned procedure
PART 2: Inability to access the pelvis (ex., patient prone/lateral position) during the planned procedure
PART 2: Known history of pelvic fibrosis or significant adhesions
PART 2: Procedures with palliative intent only
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06312124.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
I. Evaluate the acceptance of OS among nongynecologic surgical patients after completion of an educational module. (Part 1)
II. Prospectively evaluate the feasibility of incorporating OS into non-gynecologic surgery as determined by rate of completion. (Part 2)
SECONDARY OBJECTIVES:
I. Determine patients' baseline knowledge of the gynecologic anatomy and of the fallopian tubes' role in the development of ovarian cancer. (Part 1)
II. Investigate the impact of an educational module consisting of a self-guided 3D animation on knowledge of reproductive anatomy and the origins of ovarian cancer. (Part 1)
III. Determine the additional operative time and surgical incisions and instruments needed to complete OS. (Part 2)
IV. Determine the frequency of intraoperative and 30-day complications and readmissions associated with OS. (Part 2)
OUTLINE:
PART 1: Patients complete an interactive 3D animation educational module over 7 minutes on study.
PART2: Patients undergo OS over 5-20 minutes during scheduled non-gynecologic surgery.
After completion of surgical procedure, patients will be followed up for 30 days for complications and at 2-12 weeks.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMemorial Sloan Kettering Cancer Center