Hormone replacement after risk-reducing salpingo-oophorectomy
Official title: Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial
Run by Duke University · NCT06972719 · Data updated 2026-11-12
This trial will test whether adding a short educational video to usual counseling helps premenopausal people with BRCA1 or BRCA2 mutations who are planning risk-reducing salpingo-oophorectomy decide about hormone replacement therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 50 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Status | Recruiting |
| Started | September 30, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT06972719 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Premenopausal individuals under age 50 with a germline BRCA1 or BRCA2 mutation who are scheduled for risk-reducing salpingo-oophorectomy at a participating clinic and can consent in English are the intended candidates.
✕Probably not a fit
People who are postmenopausal, older than 50, have a personal history of cancer, cannot consent in English, or who are not planning RRSO are unlikely to benefit from this specific intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized pilot trial enrolling 50 premenopausal individuals with BRCA1 or BRCA2 mutations who are planning risk-reducing salpingo-oophorectomy at participating North Carolina clinics. Participants are randomized to receive usual provider education alone or usual education plus a video-based educational aid. Investigators will measure decisional conflict about HRT, satisfaction with the decision, satisfaction with counseling, and the postoperative decision about whether to use HRT. The goal is to generate pilot data to refine a comprehensive education and values-clarification aid to improve informed decision making for people facing RRSO.
Why it matters
Potential benefit: If successful, the educational aid could lower decisional conflict and increase patient satisfaction and clarity about whether to use hormone replacement after RRSO.
How similar studies have gone: Decision aids and brief video interventions have improved knowledge and reduced decisional conflict in other surgical and menopause-related settings, but an HRT-specific aid for BRCA1/2 RRSO patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
UNC Chapel Hill Health System
Chapel Hill, North Carolina, United States Recruiting -
Duke University Health System
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Laura Havrilesky — Duke University
- Study coordinator: Amelia Scott
- Email: amelia.lorenzo@duke.edu
- Phone: (919) 613-4584
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.