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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Arm | Behavioral | Participants will be randomized to SOC plus the video. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who decide to take HRT | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelia Scott | Contact | (919) 613-4584 | amelia.lorenzo@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Laura Havrilesky | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Chapel Hill Health System | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| SOC Arm |
| Behavioral |
Participants will be randomized to SOC counseling. |
|
Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication
| 3-6 months post op |
| Duke University Health System | Recruiting | Durham | North Carolina | 27710 | United States |
|