NCT06972719

Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy

Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• BRCA1 Mutation
• BRCA2 Mutation

Interventions

Type	Name	Description
BEHAVIORAL	Experimental Arm	Participants will be randomized to SOC plus the video.
BEHAVIORAL	SOC Arm	Participants will be randomized to SOC counseling.

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-07-01
• Completion: 2026-12-31
• First posted: 2025-05-15
• Last updated: 2026-03-27

Locations

2 sites across 1 country: United States