An interventional study of Experimental Arm and SOC Arm in BRCA1 Mutation and BRCA2 Mutation, sponsored by Duke University. Recruiting at 2 sites in United States. Open to female participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
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).
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: SOC Arm
The experimental arm will receive standard verbal counseling and written education plus the video-based educational aid describing the risks and benefits of HRT.
Behavioral: Experimental Arm
Participants will be randomized to SOC plus the video.
Participants will be randomized to SOC counseling.
Decisional Conflict pre-randomization
The Decisional Conflict Scale ranges from 16 to 80 with a higher score indicating greater conflict with the decision.
Time frame: Baseline, pre-randomization
Decisional Conflict post-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.
Time frame: Immediately after the intervention
Decisional Conflict post-operatively
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.
Time frame: 2-6 weeks post op
Satisfaction with Counseling
a Likert-scale questionnaire to assess their satisfaction with their preoperative counseling.
Time frame: 2-6 weeks post op
Satisfaction with Decision
The Satisfaction with Decision scale ranges from 6 to 30 with higher scores indicating greater satisfaction with their decision.
Time frame: 3-6 months post op
Number of participants who decide to take HRT
Number of participants who decide to take HRT
Time frame: 3-6 months post op
Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication
Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication
Time frame: 3-6 months post op
Plan to share: No
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