What this study is
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).
What's being tested
- Experimental Arm
Intervention · BEHAVIORAL
Participants will be randomized to SOC plus the video.
- SOC Arm
Intervention · BEHAVIORAL
Participants will be randomized to SOC counseling.
Study details
- Official title
- Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial
- Sponsor
- Duke University
- Conditions
- BRCA1 Mutation · BRCA2 Mutation
- Enrolling
- 50 people
- Starts
- 2025-09-30
- Est. completion
- 2027-06-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 19 Years – 50 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- BRCA1 or BRCA2 germline mutation
- Scheduled for a risk-reducing salpingo-oophorectomy (RRSO) by Duke Gynecologic Oncologist
- Premenopausal
You can't join if
- Personal history of cancer
- Postmenopausal
- >50 years old
- Unable to provide informed consent in English
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUNC Chapel Hill Health System
Chapel Hill, North Carolina, United States
- Katherine Tucker, MD · Contact(919) 966-2131Katherine.Tucker2@unchealth.unc.edu
- Katherine Tucker, MD · Principal investigator
RecruitingDuke University Health System
Durham, North Carolina, United States
- Amelia Scott · Contact919-613-4584amelia.lorenzo@duke.edu
- Laura Havrilesky, MD · Principal investigator
Recruiting
Study team
Sponsor
Duke University
Study ID Pro00117007
Principal investigator
Laura Havrilesky
Duke University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.