Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental Arm, SOC Arm.
- Who it may be relevant to
- Registry conditions: BRCA1 Mutation, BRCA2 Mutation. Basic parameters: 19 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial
Overview
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.
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]
- 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]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- UNC Chapel Hill Health System — Chapel Hill
- Duke University Health System — Durham
Identifiers
NCT: NCT06972719 · Pro00117007