This study investigates how cancer-related distress and/or reproductive concerns affect women’s decisions to remove or preserve their ovaries during surgery for endometrial cancer. Collecting information from patients with endometrial cancer via questionnaires may help researchers learn more about the factors that influence decision-making before surgery and the possibility of regret after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04569773.
PRIMARY OBJECTIVE:
I. Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer to identify influencing factors—in particular, cancer-related psychological distress and reproductive concerns—and any potential decisional regrets following surgical intervention.
SECONDARY OBJECTIVE:
I. Assess serum anti-Mullerian hormone (AMH) levels before and after surgery in women who choose ovarian preservation.
II. Assess patterns of first recurrence in the first 3 years after surgery.
OUTLINE:
Patients complete questionnaires over 3-10 minutes each before surgery (within 6 weeks of surgery), at the initial postoperative visit, and then at 6 and 12 months after surgery. Patients who have decided to preserve their ovaries may also undergo collection of blood samples for AMH analysis before surgery (within 6 weeks of surgery) and at 12 months after surgery.
After completion of study, patients are followed up at 24 and 36 months.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJennifer Mueller
