BRCA1 Mutation, BRCA2 Mutation
Conditions
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.
Interventions
BEHAVIORALExperimental Arm
Participants will be randomized to SOC plus the video.
BEHAVIORALSOC Arm
Participants will be randomized to SOC counseling.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict pre-randomization | 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 | 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 | 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 | 2-6 weeks post op | a Likert-scale questionnaire to assess their satisfaction with their preoperative counseling. |
| Satisfaction with Decision | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who decide to take HRT | 3-6 months post op | Number of participants who decide to take HRT |
| Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication | 3-6 months post op | Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication |
Countries
United States
Contacts
CONTACTAmelia Scott
PRINCIPAL_INVESTIGATORLaura Havrilesky
Duke University
Outcome results
None listed