Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy (BRCA HRT Pilot)

Duke University

Status: Enrolling

Conditions: BRCA2 Mutation; BRCA1 Mutation

Treatments: Behavioral: SOC Arm; Behavioral: Experimental Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT06972719

Pro00117007

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Standard of Care

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: SOC Arm

Experimental

Experimental group

Description:

The experimental arm will receive standard verbal counseling and written education plus the video-based educational aid describing the risks and benefits of HRT.

Treatment:

Behavioral: Experimental Arm