Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy
Purpose
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).
Conditions
- BRCA1 Mutation
- BRCA2 Mutation
Eligibility
- Eligible Ages
- Between 19 Years and 50 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Durham, North Carolina 27710
More Details
- NCT ID
- NCT06972719
- Status
- Recruiting
- Sponsor
- Duke University
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.