Telephone-Based Genetic Counseling; An Equivalence Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 669
- 试验地点
- 4
- 主要终点
- Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months
研究概览
简要总结
RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
详细描述
OBJECTIVES:
Primary
- Compare the impact of telephone genetic counseling (TGC) versus standard genetic counseling (SGC) on utilization of BRCA1/BRCA2 testing in women at risk of carrying the BRCA1/BRCA2 mutation.
- Compare the relative efficacy of TGC versus SGC on satisfaction with the counseling process, informed decision making, psychosocial distress, and quality of life.
Secondary
- Identify participant characteristics that predict differential response to TGC.
- Explore the mechanisms by which TGC or SGC impact distress and quality of life.
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Must have at least 10% chance of carrying the BRCA1/BRCA2 gene, as defined by ≥ 1 of the following:
- •First-degree relative of affected family member with a 50% chance of inheriting a BRCA1/BRCA2 mutation
- •Second-degree relative with BRCA1/BRCA2 mutation with 25% risk of inheritance (parent deceased)
- •Obligate gene carrier or affected woman
- •Must live within 100 miles of the Lombardi Comprehensive Cancer Center
- •No more than 4 weeks since breast or ovarian cancer diagnosis
- •No metastatic or inflammatory breast cancer or ovarian cancer
- •No stage III breast or ovarian cancer while undergoing concurrent chemotherapy
- •PATIENT CHARACTERISTICS:
- •No psychiatric illness or cognitive disorder that would preclude informed consent
- •PRIOR CONCURRENT THERAPY:
- •No prior genetic counseling or testing for BRCA1 and/or BRCA2
排除标准
- 未提供
研究组 & 干预措施
Telephone Genetic Counseling
Participants randomized to this arm will receive all genetic counseling via telephone.
干预措施: Telephone Genetic Counseling (Behavioral)
Usual Care
Participants randomized to usual care will receive standard in-person genetic counseling.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months
时间窗: 6 months
Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months
时间窗: 3 months
Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months
时间窗: 3 months
Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months
时间窗: 6 months
Quality of life as assessed by SF-12 health survey at 3 and 6 months
时间窗: 6 months
次要结局
- Costs by cost measurement post-counseling(6 months)
- Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months(12 months)