Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- Decision Satisfaction
研究概览
简要总结
This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergo BRCA1/2 genetic counseling and testing at one of four study sites
- •Receive positive or uninformative test results
- •English speaking
排除标准
- •Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment
- •Previous bilateral mastectomy
研究组 & 干预措施
Mutation Carrier: Enhanced Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool.
干预措施: Enhanced Internet DA (Behavioral)
Mutation Carrier: Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool.
干预措施: Internet DA (Behavioral)
Mutation Carrier: Enhanced Print DA
BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool.
干预措施: Enhanced Print DA (Behavioral)
Mutation Carrier: Print DA
BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool.
干预措施: Print DA (Behavioral)
Inconclusive Results: DA
Participants who receive inconclusive results who are randomized to this arm will have access to an Internet decision tool designed to facilitate management decision making
干预措施: Inconclusive Results DA (Behavioral)
Inconclusive Results: Usual care
Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention
结局指标
主要结局
Decision Satisfaction
时间窗: 12-months post-randomization
Satisfaction with Decision Scale
Psychological Distress
时间窗: 1-month post randomization
Decision Conflict
时间窗: 1-month post-randomization
Decisional Conflict Scale
Knowledge
时间窗: 1-month post randomization
Knowledge of risk management options.
Health Related Quality of Life
时间窗: 12-months post randomization
SF-12
Utilization of breast and ovarian cancer risk management options
时间窗: 12-months post-randomization
We will assess uptake of the following risk management strategies: 1. Risk reducing surgery (mastectomy and oophorectomy) 2. Chemoprevention 3. Breast and ovarian cancer screening
次要结局
- Knowledge(3-months post randomization)
- Psychological Distress(3-months post-randomization)
- Decisional Conflict(3-months post-randomization)