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临床试验/NCT02225015
NCT02225015Unknown1 期

Cancer Prevention in Women With a BRCA Mutation: A Follow-up Genetic Counselling Intervention

Women's College Hospital6 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年1月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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