Menopausal Therapy in Women at Increased Risk for Breast Cancer: Does a Personalized Risk Assessment and Counseling Intervention Aid in Decision-Making?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Medication usage
研究概览
简要总结
The purpose of this study is to determine the effects of a personalized menopausal therapy risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in healthy women at increased risk for breast cancer.
详细描述
Women with a family history of breast cancer have several menopausal therapy options, including tamoxifen, hormone therapy, alternative medications, or no treatment. This complex decision should be based on each woman's risk to develop breast cancer, menopausal symptoms, preferences, and risks for other conditions. Current models in use for menopausal therapy counseling do not include pedigree analysis, personalized risk assessment or genetic testing in this process. The purpose of this multi-center study is to determine the effects of a personalized risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in a group of healthy women who had a first-degree relative with breast cancer. Intervention participants will be given a personalized risk assessment for breast cancer, heart disease, osteoporosis, and uterine cancer based on family history and personal health data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •at least one first degree relative with breast cancer
- •age 40 or older
排除标准
- •currently taking a menopausal therapy
- •previous cancer diagnosis (except basal cell carcinoma)
- •previous diagnosis of atypical hyperplasia
- •previous diagnosis of lobular carcinoma in situ (LCIS)
- •known carrier of a BRCA1 or BRCA2 mutation
- •personal history of heart disease
- •>10% risk of carrying a BRCA1 or BRCA2 mutation
结局指标
主要结局
Medication usage
Decisional conflict
Knowledge of menopause and menopausal therapy
Satisfaction with counseling intervention
次要结局
- Perceived risk of breast cancer, heart disease, osteoporosis
- Worry about breast cancer, heart disease, osteoporosis
