BRCA1 MutationBRCA HRT PilotNCT06972719
Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy
A study testing Experimental Arm and SOC Arm in people with BRCA1 Mutation and BRCA2 Mutation, run by Duke University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- BRCA1 Mutation, BRCA2 Mutation
- What is being tested?
- Experimental Arm and SOC Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BRCA1 or BRCA2 germline mutation
- scheduled for a risk-reducing salpingo-oophorectomy (RRSO) by Duke Gynecologic Oncologist
- premenopausal
Who cannot join
- personal history of cancer
- postmenopausal
- >50 years old
- unable to provide informed consent in English
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UNC Chapel Hill Health System
Chapel Hill, North Carolina, 27514
Katherine Tucker, MD, (919) 966-2131, Katherine.Tucker2@unchealth.unc.edu
Katherine Tucker, MD
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
Amelia Scott, 919-613-4584, amelia.lorenzo@duke.edu
Laura Havrilesky, MD
About this study
Official title: Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial
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).
Read the detailed 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.
- Conditions
- BRCA1 Mutation, BRCA2 Mutation
- Being tested
- Experimental Arm, SOC Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ArmBehavioural
Participants will be randomized to SOC plus the video.
SOC ArmBehavioural
Participants will be randomized to SOC counseling.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Placebo comparator | 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. Receives: Behavioral: SOC Arm |
| Experimental | 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. Receives: Behavioral: Experimental Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict pre-randomization
The Decisional Conflict Scale ranges from 16 to 80 with a higher score indicating greater conflict with the decision.
Measured: Baseline, pre-randomization
Decisional Conflict post-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.
Measured: Immediately after the intervention
Decisional Conflict post-operatively
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.
Measured: 2-6 weeks post op
Satisfaction with Counseling
a Likert-scale questionnaire to assess their satisfaction with their preoperative counseling.
Measured: 2-6 weeks post op
Satisfaction with Decision
The Satisfaction with Decision scale ranges from 6 to 30 with higher scores indicating greater satisfaction with their decision.
Measured: 3-6 months post op
Secondary outcomes (2)
Number of participants who decide to take HRT
Number of participants who decide to take HRT
Measured: 3-6 months post op
Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication
Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication
Measured: 3-6 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start30 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA1 MutationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Havrilesky, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972719
- Sponsor's protocol ID
- Pro00117007
- Acronym
- BRCA HRT Pilot
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06972719
- Acronym / sponsor ID
- BRCA HRT Pilot / Pro00117007
- Conditions
- BRCA1 Mutation, BRCA2 Mutation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Placebo comparator | Behavioral: SOC ArmThe 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. |
| Experimental | Experimental | Behavioral: Experimental ArmThe experimental arm will receive standard verbal counseling and written education plus the video-based educational aid describing the risks and benefits of HRT. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BRCA1 or BRCA2 germline mutation
- scheduled for a risk-reducing salpingo-oophorectomy (RRSO) by Duke Gynecologic Oncologist
- premenopausal
Key exclusion criteria (4 listed)
- personal history of cancer
- postmenopausal
- >50 years old
- unable to provide informed consent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental ArmParticipants will be randomized to SOC plus the video. | Behavioural | Experimental |
| SOC ArmParticipants will be randomized to SOC counseling. | Behavioural | Standard of Care |
Primary outcome
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.
2 secondary outcomes
Number of participants who decide to take HRT
Time frame: 3-6 months post op
Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication
Time frame: 3-6 months post op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Havrilesky principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Arm and SOC Arm in people with BRCA1 Mutation and BRCA2 Mutation, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelia Scott ((919) 613-4584, amelia.lorenzo@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict pre-randomization (time frame: Baseline, pre-randomization). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.