Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Decisional Conflict pre-randomization
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BRCA1 or BRCA2 germline mutation
- •scheduled for a risk-reducing salpingo-oophorectomy (RRSO) by Duke Gynecologic Oncologist
- •premenopausal
排除标准
- •personal history of cancer
- •postmenopausal
- •>50 years old
- •unable to provide informed consent in English
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Experimental Arm (Behavioral)
结局指标
主要结局
Decisional Conflict pre-randomization
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 2-6 weeks post op
a Likert-scale questionnaire to assess their satisfaction with their preoperative counseling.
Satisfaction with Decision
时间窗: 3-6 months post op
The Satisfaction with Decision scale ranges from 6 to 30 with higher scores indicating greater satisfaction with their decision.
次要结局
- 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)