Cancer Prevention in Women With a BRCA Mutation: A Follow-up Genetic Counselling Intervention
试验速览
- 阶段
- 1 期
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Efficacy of FTGC session
研究概览
简要总结
This study aims to develop a follow-up telephone-based genetic counselling (FTGC) intervention for women with a BRCA1 or BRCA2 mutation who have received genetic counseling in the past. Typically, when women undergo genetic testing, they receive standard genetic counselling prior to testing in order to fully understand the procedure and associated implications. If a woman's genetic test results are positive for a mutation, cancer prevention options are then discussed with a counsellor. However, in Canada, there is currently no formal follow-up counselling for women with a BRCA mutation to provide ongoing guidance and support about latest risk reduction strategies. Standard care relies on women making contact for any follow-up questions or concerns they may have. As a result, these women might not have the most current information regarding genetic risk assessment and prevention options. Therefore, individuals are being asked to participate in this study to aid research about the efficacy of FTGC in women with a BRCA mutation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed BRCA mutation
- •Age 35 to 70 years
- •No previous bilateral salpingo-oophorectomy
- •No previous or current ovarian cancer
- •At least 12 months since genetic testing or most recent contact by Narod follow-up study
- •Can speak and understand English
排除标准
- •Currently receiving treatment for another cancer diagnosis
- •Given birth in the last 6 months
- •Booked surgical date for BSO
结局指标
主要结局
Efficacy of FTGC session
时间窗: 3 years
The primary aim is to determine the effects of a tailored risk communication intervention (FTGC) compared to a standard intervention
次要结局
- Emotional and cognitive outcomes of intervention(3 yrs)
