Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy

Not Applicable

Not yet recruiting

• Conditions: BRCA1 Mutation; BRCA2 Mutation

• Registration Number: NCT06972719
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2025-04-30
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Study Start: 2025-06-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decisional Conflict pre-randomization	Baseline, pre-randomization	The Decisional Conflict Scale ranges from 16 to 80 with a higher score indicating greater conflict with the decision.
Decisional Conflict post-intervention	Immediately after the intervention	Decisional conflict will be reassessed preoperatively after all materials have been reviewed. The Decisional Conflict Scale ranges from 16 to 80 with a higher score indicating greater conflict with the decision.
Decisional Conflict post-operatively	2-6 weeks post op	Decisional conflict will be reassessed postoperatively. The Decisional Conflict Scale ranges from 16 to 80 with a higher score indicating greater conflict with the decision.
Satisfaction with Counseling	2-6 weeks post op	a Likert-scale questionnaire to assess their satisfaction with their preoperative counseling.
Satisfaction with Decision	3-6 months post op	The Satisfaction with Decision scale ranges from 6 to 30 with higher scores indicating greater satisfaction with their decision.

Secondary Outcome Measures

Name	Time	Method
Number of participants who decide to take HRT	3-6 months post op	Number of participants who decide to take HRT
Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication	3-6 months post op	Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication