Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial
Duke University
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).
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 comprehens…
Eligibility
- Age range
- 19–50 years
- Sex
- Female
- 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
Interventions
- BehavioralExperimental Arm
Participants will be randomized to SOC plus the video.
- BehavioralSOC Arm
Participants will be randomized to SOC counseling.
Locations (2)
- UNC Chapel Hill Health SystemChapel Hill, North Carolina
- Duke University Health SystemDurham, North Carolina