Genetic Counseling for Menopausal Therapy Decision-Making for Women at Increased Risk for Breast Cancer
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Details and patient eligibility
About
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.
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.
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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