Parent Communication Study II - Randomized Controlled Trial of Decision Support vs. Education for Parent Communication of BRCA 1/2 Cancer Genetic Test Results to Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 4
- 主要终点
- Decision conflict, as assessed by the Decisional Conflict Scale
研究概览
简要总结
RATIONALE: A study that evaluates the support of a decision guide used together with genetic counseling may improve communication between mothers undergoing BRCA1/2 testing and their minor-age children.
PURPOSE: This randomized phase III trial is studying standard genetic counseling given together with a decision guide to see how well it works compared with genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy of a decision support intervention delivered in conjunction with standard genetic counseling compared to standard genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.
Secondary
- To understand the mechanisms by which decision support impacts on decision outcomes.
- To identify mothers who are most and least likely to benefit from decision support.
- To explore the potential impact of decision support on disclosure and parent-child psychosocial well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Decision conflict, as assessed by the Decisional Conflict Scale
时间窗: 6 months
Self-reported outcomes at 1-and 6-months
时间窗: 6 months
Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale
时间窗: 6 months
Disclosure of genetic testing results by parents
时间窗: 6 months
Child-rearing alliance between parents, as measured by the Parenting Alliance Measure at baseline, after learning test results, and at 1 and 6 months after genetic counseling
时间窗: 6 months
Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children
时间窗: 6 months
Decision quality
时间窗: 6 months
Parent-child communication, as assessed by the Parent-Adolescent Communication Scale at baseline, after learning test results, and at 1 and 6 months after genetic counseling
时间窗: 6 months
Parents' preferences and values regarding family communication of genetic test results
时间窗: 6 months
Family functioning, as assessed by the Family Relationship Index at baseline, after learning test results, and at 1 and 6 months after genetic counseling
时间窗: 6 months
Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale
时间窗: 6 months
Cognitive appraisals
时间窗: 6 months
Children's stress and worry, as assessed by the Child Behavior Checklist at baseline, after learning test results, and at 1 and 6 months after genetic counseling
时间窗: 6 months
次要结局
未报告次要终点