Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy

NCT ID: NCT06972719

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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BRCA1 Mutation BRCA2 Mutation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of Care

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.

Group Type PLACEBO_COMPARATOR

SOC Arm

Intervention Type BEHAVIORAL

Participants will be randomized to SOC counseling.

Experimental

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

Group Type EXPERIMENTAL

Experimental Arm

Intervention Type BEHAVIORAL

Participants will be randomized to SOC plus the video.

Interventions

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Experimental Arm

Participants will be randomized to SOC plus the video.

Intervention Type BEHAVIORAL

SOC Arm

Participants will be randomized to SOC counseling.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Havrilesky

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Health System

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amelia Scott

Role: CONTACT

(919) 613-4584

Facility Contacts

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Amelia Scott

Role: primary

919-613-4584

Other Identifiers

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Pro00117007

Identifier Type: -

Identifier Source: org_study_id

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