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NCT06972719NARecruiting

Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy

Duke University

Start Date

9/30/2025

Completion Date

12/31/2026

Summary

The goal of this study is to develop an educational aid about hormone replacement therapy that physicians can share with patients as part of their pre-surgical counseling for a risk-reducing salpingo-oophorectomy (RRSO).

Detailed Description

The proposed randomized study seeks to enroll 50 individuals from gynecologic oncology and high-risk breast clinics who are actively planning RRSO. Participants will be randomized to usual provider education versus usual education plus video education. The researchers will assess participants' level of conflict around the decision to use HRT, their satisfaction with their decision, their satisfaction with their counseling, and their postoperative decision regarding HRT. This project will provide pilot data for a larger randomized trial. Ultimately, the investigators seek to create a comprehensive aid for education and values clarification, with the aim of improving informed decision making for individuals with BRCA1-2 mutations.

Eligibility Criteria

Age Range: 19 years to 50 years

Inclusion Criteria: * BRCA1 or BRCA2 germline mutation * scheduled for a risk-reducing salpingo-oophorectomy (RRSO) by Duke Gynecologic Oncologist * premenopausal Exclusion Criteria: * personal history of cancer * postmenopausal * \>50 years old * unable to provide informed consent in English

Interventions

BEHAVIORAL

Experimental Arm

BEHAVIORAL

SOC Arm

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Conditions

BRCA1 MutationBRCA2 Mutation

Locations

UNC Chapel Hill Health System

Chapel Hill, North Carolina 27514

United States

Duke University Health System

Durham, North Carolina 27710

United States