Breast Cancer Clinical Trial

Genetic Counseling for Menopausal Therapy Decision-Making for Women at Increased Risk for Breast Cancer

Summary

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.

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Full Description

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.

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Eligibility Criteria

Inclusion Criteria:

at least one first degree relative with breast cancer
age 40 or older

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

60

Study ID:

NCT00349011

Recruitment Status:

Completed

Sponsor:

Yale University

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There is 1 Location for this study

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Yale Cancer Genetic Counseling, Yale Cancer Center, Yale University School of Medicine
New Haven Connecticut, 06510, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

60

Study ID:

NCT00349011

Recruitment Status:

Completed

Sponsor:


Yale University

How clear is this clinincal trial information?

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