Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Decisional Conflict pre-randomization
Study Overview
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).
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: SOC Arm (Behavioral)
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.
Intervention: Experimental Arm (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)