NCT00858078已完成不适用
A Qualitative Exploration of the Impact of Positive BRCA 1/2 Mutation Status on the Lives of Young Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Telephone Interviews
研究概览
简要总结
Background:
- Mutations detected in the BRCA1 or BRCA2 genes have been show to produce very high risks of breast and ovarian cancer (as high as 90% and 60%, respectively), as well as accompanying risks for several other types of cancer. Women who have these genetic anomalies and who do not have cancer are aware of their high-risk status, which can have an effect on their ability to make decisions about personal choices and health care.
- Researchers are interested in learning more about how people who know their cancer risk status make decisions on personal relationships, family formation, and risk-reduction options.
Objectives:
- To study young women s experiences and decision-making processes regarding family history, genetic testing, couple relationships, family formation, and cancer risk management within the context of their experiences as BRCA1/2 mutation carriers.
Eligibility:
- Women between the ages of 18 and 35 years of age and older who have been identified as having a BRCA1 or BRCA2 mutation. Participants must be contemplating or have experienced couple relationships, family formation, and/or risk management and reduction.
- Participants must be willing to have their interviews digitally recorded
Design:
- Researchers will conduct between 30 and 50 telephone interviews of study participants. Each interview will be approximately 90 minutes in length. The interview consists of open-ended questions that ask about the participants and their experiences before, during, and after they underwent genetic testing for BRCA1/2.
- At least one focus group will be coordinated at a national conference for individuals who are aware of their genetically based cancer risk. If more than 25 individuals are interested in participating in the group, an additional focus group will be convened.
- No medical treatments are specifically offered as a part of this study.
详细描述
Background:
- BRCA1/2 mutations are present in approximately 1 in 800 individuals in the US, with higher frequency among some populations (e.g., Ashkenazi Jews)
- Mutations confer a lifetime breast cancer risk approaching 90%, ovarian cancer risk as high as 60%, and lesser increases in absolute risks of selected other cancers (e.g., male breast, prostate, pancreas).
- We have successfully conducted follow-up interviews with women in our original studies who had known about their mutations for less than six months, and have gleaned useful longitudinal data. We now propose to conduct additional follow-up interviews with participants who were in the process of making significant decisions about risk-management, relationships, family formation, and other pertinent issues at the time of their initial interviews.
- Additionally, previous research indicates that women who undergo genetic testing very early in young adulthood (i.e., prior to their 25th birthdays) have genetic counseling and support needs that are different from the broader BRCA-positive population.
- Research regarding how these very young mutation carriers manage and accommodate their risk is scarce. We propose to conduct two focus groups with women who considered and/or underwent genetic testing for BRCA prior to their 25th birthdays, who are attending the Joining FORCES annual conference in Orlando, FL June 23-25, 2011.
- The Study Application has been updated with this amendment to reflect the following changes: 1) the inclusion of males who may be enrolled only in the Family Group Interview component of the study & 2) the inclusion older individuals as some women may wish to include male or older members of their family in Family Group Interview portion of the study. To reflect this change the maximum age for study participants has been increased to 100 years of age and males are no longer listed as excluded from the study.
Objectives:
- For follow-up to previous study:
-- Conduct follow-up telephone interviews with participants who were newly-tested at the time of original data collection to increase understanding of their mutation-positive experience longitudinally.
- For 25 & Under study:
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（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
Telephone Interviews
时间窗: ongoing
Conduct follow-up telephone interviews with participantswho were newly-tested at the time of original data collection to increase understanding of their mutationpositive experience longitudinally.
Focus Group Sessions
时间窗: ongoing
Conduct two (2) focus group sessions at the JoiningFORCES Annual Conference, focusing on the unique geneticcounseling and support needs of women who consider or undergo genetic testing for BRCA1/2 prior to age 25.
次要结局
未报告次要终点
研究者
研究点 (1)
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