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NCT06972719 · Duke University

Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy

(BRCA HRT Pilot)

What this study is 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).

View original scientific description

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).

Interventions

BEHAVIORAL

Experimental Arm

Participants will be randomized to SOC plus the video.

BEHAVIORAL

SOC Arm

Participants will be randomized to SOC counseling.

Primary outcome measures

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.

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.

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.

Satisfaction with Counseling

Time frame: 2-6 weeks post op

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

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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

Where

  • Chapel Hill, North Carolina
  • Durham, North Carolina

Related conditions & keywords

BRCA1 MutationBRCA2 Mutation

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations

📊
1 of 50 participants interested
2% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Chapel Hill

North Carolina

Location available
RECRUITING

Durham

North Carolina

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Looking for BRCA1 Mutation Treatment in Chapel Hill?

Join others in North Carolina exploring innovative treatment options through clinical research

BRCA1 Mutation Treatment Options in Chapel Hill, North Carolina

If you're searching for BRCA1 Mutation treatment in Chapel Hill, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Chapel Hill, Durham and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with BRCA1 Mutation. All study-related care is provided at no cost to participants.

Local Sites
2 locations in North Carolina
Now Enrolling
Up to 50 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for BRCA1 Mutation?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for BRCA1 Mutation

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This BRCA1 Mutation Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06972719. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.