Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Duke University
Study ID
NCT06972719
Status
Recruiting
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Conditions

  • BRCA1 Mutation
  • BRCA2 Mutation

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental Arm — BEHAVIORAL
    Participants will be randomized to SOC plus the video.
  • SOC Arm — BEHAVIORAL
    Participants will be randomized to SOC counseling.

Study Details

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).

Key Dates

Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Jul 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Decisional Conflict pre-randomization [ Time Frame: Baseline, pre-randomization ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UNC Chapel Hill Health SystemChapel HillNorth Carolina27514
Katherine Tucker, MD
[email protected]
919-966-2131
Katherine Tucker, MD (PRINCIPAL_INVESTIGATOR)
Duke University Health SystemDurhamNorth Carolina27710
Amelia Scott
[email protected]
919-613-4584
Laura Havrilesky, MD (PRINCIPAL_INVESTIGATOR)

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UNC Chapel Hill Health System· Chapel Hill, NCDuke University Health System· Durham, NC

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