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NCT Number: NCT06972719

Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy

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).

Recruiting

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Key information

Conditions

BRCA1 Mutation BRCA2 Mutation

Age range

19 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Chapel Hill Health System, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental arm

Behavioral

Participants will be randomized to SOC plus the video.

SOC Arm

Behavioral

Participants will be randomized to SOC counseling.

Primary outcomes

  1. Decisional Conflict pre-randomization

    Time frame: Baseline, pre-randomization

    The Decisional Conflict Scale ranges from 16 to 80 with a higher score indicating greater conflict with the decision.

  2. Decisional Conflict post-intervention

    Time frame: Immediately after the 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.

  3. Decisional Conflict post-operatively

    Time frame: 2-6 weeks post op

    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.

  4. Satisfaction with Counseling

    Time frame: 2-6 weeks post op

    a Likert-scale questionnaire to assess their satisfaction with their preoperative counseling.

  5. Satisfaction with Decision

    Time frame: 3-6 months post op

    The Satisfaction with Decision scale ranges from 6 to 30 with higher scores indicating greater satisfaction with their decision.

Secondary outcomes

  1. Number of participants who decide to take HRT

    Time frame: 3-6 months post op

    Number of participants who decide to take HRT

  2. Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication

    Time frame: 3-6 months post op

    Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication

Study contacts

Contact information is provided by the study sponsor or research team.

Amelia Scott

CONTACT

[email protected]

(919) 613-4584

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: BRCA HRT Pilot

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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