Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy

NCT06972719 | Recruiting

• 1 other identifier: Pro00117007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (5)

• Decisional Conflict pre-randomization

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

  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.

  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.

  2-6 weeks post op

• Satisfaction with Counseling

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

  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.

  3-6 months post op

Secondary Outcomes (2)

• Number of participants who decide to take HRT

  3-6 months post op

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

  3-6 months post op

Study Arms (2)

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.

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.

Behavioral: Experimental Arm

Interventions

Experimental Arm BEHAVIORAL

Participants will be randomized to SOC plus the video.

Experimental

SOC Arm BEHAVIORAL

Participants will be randomized to SOC counseling.

Standard of Care

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BRCA1 or BRCA2 germline mutation
• scheduled for a risk-reducing salpingo-oophorectomy (RRSO) by Duke Gynecologic Oncologist
• premenopausal

You may not qualify if:

• personal history of cancer
• postmenopausal
• \>50 years old
• unable to provide informed consent in English

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

UNC Chapel Hill Health System

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Duke University Health System

Durham, North Carolina, 27710, United States

RECRUITING

Study Officials

• Laura Havrilesky

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelia Scott

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 15, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)