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临床试验/NCT01866865
NCT01866865已完成不适用

Adaptation to Living With a BRCA l/2 Mutation in Carriers and Their Partners

National Human Genome Research Institute (NHGRI)1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2013年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
142
试验地点
1
主要终点
the primary outcome is psychological adaptation

研究概览

简要总结

Background:

  • Women who have a BRCA1/2 gene mutation have a very high risk of developing breast or ovarian cancer. They are also at increased risk of other developing other cancers. Male carriers are at increased risk for breast, prostate and other cancers. Testing for this mutation and living with this increased risk can be a source of stress for both people with the mutation and their partners. Researchers want to look at how well people adapt to living with this type of cancer risk over time.

Objectives:

  • To see how women with the BRCA1/2 gene mutation and their partners adapt to the stress of long-term cancer risk.

Eligibility:

  • Women at least 18 years of age who have a BRCA1/2 mutation, and their male or female partners.

Design:

  • This study involves a one-time self-administered questionnaire. Participants will be recruited from local and national hereditary cancer support groups and cancer centers.
  • There are two versions of the survey. One is for the woman with the BRCA1/2 gene mutation. The other is for her partner.
  • The survey will ask about risk perception, cancer worry, risk-related stress, and coping and adaptation methods.
  • Treatment will not be provided as part of this study.

详细描述

The proposed study aims to describe adaptation and dyadic adjustment in unaffected BRCA1/2 carriers and their partners. It is not fully understood how women and their partners adapt to highrisk status over time, nor how different aspects of living at risk relate to this process. Neither psychological adaptation nor dyadic adjustment has been systematically measured in this population. This study is informed by Lazarus & Folkman s Transactional Model of Stress and Coping and modifications made to this model for use in studying dyadic relationships. A crosssectional research design will quantitatively explore the relationships between the appraisals and timing of risk-related stressors, dyadic coping, and the outcomes of adaptation and dyadic adjustment. Participants will be recruited from hereditary breast and ovarian cancer (HBOC) support groups, website postings, listservs, and clinic patient lists. They will have the option of completing either a paper or online version of the survey.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

the primary outcome is psychological adaptation

时间窗: 1 time survey

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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