Recruiting

Hormone Replacement Therapy

Sponsor:

Duke University

Code:

NCT06972719

Conditions

BRCA1 Mutation

BRCA2 Mutation

Eligibility Criteria

Sex: Female

Age: 19 - 50

Healthy Volunteers: Not accepted

Interventions

Experimental Arm

SOC Arm

Study Details

Brief 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).

Conditions

BRCA1 Mutation

BRCA2 Mutation

Study ID

NCT06972719

Start date

Sep 30, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: 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.

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.

Interventions

Experimental Arm

Participants will be randomized to SOC plus the video.

SOC Arm

Participants will be randomized to SOC counseling.

Primary outcome measure

  • Decisional Conflict pre-randomization [ Time Frame: Baseline, pre-randomization ]
  • Decisional Conflict post-intervention [ Time Frame: Immediately after the intervention ]
  • Decisional Conflict post-operatively [ Time Frame: 2-6 weeks post op ]
  • Satisfaction with Counseling [ Time Frame: 2-6 weeks post op ]
  • Satisfaction with Decision [ Time Frame: 3-6 months post op ]

Central Contacts and Locations

Central contacts

Amelia Scott

(919) 613-4584amelia.lorenzo@duke.edu

Locations

UNC Chapel Hill Health System

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Katherine Tucker, MD

(919) 966-2131Katherine.Tucker2@unchealth.unc.edu

Principal Investigator:

Katherine Tucker, MD

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Amelia Scott

919-613-4584amelia.lorenzo@duke.edu

Principal Investigator:

Laura Havrilesky, MD

More Information

Sponsor

Duke University

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-04.