跳至主要内容
临床试验/NCT00349011
NCT00349011已完成不适用

Menopausal Therapy in Women at Increased Risk for Breast Cancer: Does a Personalized Risk Assessment and Counseling Intervention Aid in Decision-Making?

Yale University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2002年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
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

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

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验