Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial

What this Trial Is About

This research aims to develop and test an educational aid about hormone replacement therapy (HRT) for people with BRCA1 or BRCA2 mutations who are planning a risk-reducing salpingo-oophorectomy (RRSO). The study evaluates the impact of this aid on patients' decision-making conflict, satisfaction with their decision and counseling, and their choices about HRT after surgery. The goal is to improve how patients understand and decide on HRT after this surgery through better education and values clarification. Participants will be randomly assigned to one of two groups. The control group receives the usual counseling from their gynecologic oncologist along with standardized written education after their visit. The experimental group receives the same standard counseling and written materials plus a video-based educational aid explaining the risks and benefits of HRT. This pilot randomized controlled trial will enroll about 50 participants from gynecologic oncology and high-risk breast clinics. Throughout the study, participants’ levels of decision conflict will be assessed before randomization, immediately after the intervention, and 2 to 6 weeks after surgery. Satisfaction with counseling will be measured 2 to 6 weeks post-operation, and satisfaction with their decision about HRT will be assessed 3 to 6 months after surgery. Researchers will also track how many participants choose to use HRT and the type of hormone therapy they select. The study is expected to provide important data to guide informed decision-making for individuals with BRCA mutations considering RRSO.

Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy