Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 50
Healthy Volunteers: f
View:
• BRCA1 or BRCA2 germline mutation
• scheduled for a risk-reducing salpingo-oophorectomy (RRSO) by Duke Gynecologic Oncologist
• premenopausal
Locations
United States
North Carolina
Duke University Health System
RECRUITING
Durham
Contact Information
Primary
Amelia Scott
amelia.lorenzo@duke.edu
(919) 613-4584
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Placebo_comparator: Standard of Care
The control arm will receive standard counseling regarding post operative HRT by their gynecologic oncologist during their visit, as well as standardized written education in their after-visit summary.
Experimental: Experimental
The experimental arm will receive standard verbal counseling and written education plus the video-based educational aid describing the risks and benefits of HRT.
Related Therapeutic Areas
Sponsors
Leads: Duke University