Clinical Application of the European Horizon 2020 Research Project "BRIDGES" - Study of the Psychological Impact of Breast Cancer Risk Communication in Cancer Genetics Based on the Personalized Estimation of the BOADICEA V5/PLUS Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 4
- 主要终点
- Psychosocial Assessment in Hereditary Cancer questionnaire (PAHC).
研究概览
简要总结
Study of the psychological impact of breast cancer risk communication in Cancer Genetics based on the personalized estimation of the BOADICEA V5/PLUS model ("Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-version 5 or PLUS").
详细描述
The new BC gene testing and risk estimation using BOADICEA V5/PLUS model imply an increased complexity of communication during the cancer genetic consultation. It will be proposed to women referred to genetic counselling in the participating Cancer Genetic Clinics .
New qualitative (moderate risks, secondary results) and quantitative results (variation in the degree of cancer risk identified for the counselee and family members) and thus a personalized breast cancer risk may be obtained. How this complexity affects counselees' psychological reactions is not known.
It is primarily aimed at comparing psychosocial needs and distress in healthy women (unaffected with BC) at high risk of breast or ovarian cancer undergoing genetic testing based on an enriched gene panel (index case gene panel plus PRS) at Curie Institute in France and at the University Hospital in Cologne, Germany.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy woman, relative of a family member first tested (index case) who received a positive genetic test result (presence of a BRCA1 or BRCA2 deleterious variant or a moderate-penetrance BC gene deleterious variant) ;
- •a. at Cologne University Hospital (Germany), these healthy women may also be relatives of women (index case) who received a negative non-informative test result;
- •Who accept BRIDGES gene panel testing and the breast cancer risk PRS;
- •Aged 18 years or over with no upper limit;
- •Able to give informed written consent in accordance with national/local regulations and procedures;
- •Able to understand the questionnaire language of the participating genetic clinic.
排除标准
- •Woman affected with BC, with recurrent BC, with metastatic BC, with an ovarian cancer (OC) or cancer of any other site;
- •Aged under 18 years old;
- •Unable to give informed written consent;
- •Unable to understand the questionnaire language of the participating clinic;
- •Unable to answer the questionnaire due to physical or cognitive disturbance
结局指标
主要结局
Psychosocial Assessment in Hereditary Cancer questionnaire (PAHC).
时间窗: Up to 6 months
Breast or ovarian cancer risk perception (the impact of communicating a personalized breast cancer risk using the BOADICEAV5/PLUS model) using a PAHC questionnaire. Questionnaire items are responded on a 4-level scale from 1 (Not at all) to 4 (Very much). Item response scores are averaged and standardized on a 0 to 100 scale, with an increased value indication more severe difficulties.
次要结局
- Difference on the PAHC score between counselees who receive a pathogenic variant indicating breast cancer versus (VS) who did not receive such result(Up to 6 months)
- Percentage of counselees intending to undertake risk reducing mastectomy (the one who received a pathogenic variant VS who did not receive such result)(Up to 6 months)
- Percentage of counselees who communicate their result to their sister(s) (the one who received a pathogenic variant VS who did not receive such result)(Up to 6 months)