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Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy

Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy

Recruiting
19-50 years
Female
Phase N/A

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Overview

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).

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

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

Study details
    BRCA1 Mutation
    BRCA2 Mutation

NCT06972719

Duke University

16 October 2025

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