Hormone Replacement Therapy Education for BRCA1/2 Mutation Carriers
This study aims to improve how women with BRCA1 or BRCA2 mutations, who are planning a risk-reducing salpingo-oophorectomy (RRSO – surgery to remove ovaries and fallopian tubes to lower cancer risk), learn about hormone replacement therapy (HRT). Researchers are testing if an educational video, in addition to standard counseling, helps women make decisions about HRT. You may be able to join if you are a woman between 19 and 50 years old, have a BRCA1 or BRCA2 mutation, are premenopausal, and are scheduled for an RRSO at Duke. The study will look at how confident you feel about your HRT decision before and after the intervention, and 2-6 weeks after your surgery. The study is currently recruiting about 50 participants.
- Study design
- This is an interventional study that plans to enroll 50 women. Participants will be randomly assigned to either receive standard counseling or standard counseling plus an educational video.
- What's involved
- Participants will receive counseling and potentially an educational video. Your decisional conflict will be measured at baseline, immediately after the intervention, and 2-6 weeks after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 2-6 weeks after their surgery to assess their decisional conflict.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy
At a glance
Conditions
NCT06972719
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Duke University Health System
Durham, North Carolinastudy coordinator listed
Recruiting
UNC Chapel Hill Health System
Chapel Hill, North Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Laura Havrilesky · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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Inclusion
Exclusion
What this trial measures
- Decisional Conflict pre-randomizationBaseline, pre-randomization
The Decisional Conflict Scale ranges from 16 to 80 with a higher score indicating greater conflict with the decision.
- Decisional Conflict post-interventionImmediately 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-operatively2-6 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 Counseling2-6 weeks post op
a Likert-scale questionnaire to assess their satisfaction with their preoperative counseling.
- Satisfaction with Decision3-6 months post op
The Satisfaction with Decision scale ranges from 6 to 30 with higher scores indicating greater satisfaction with their decision.