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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Menopause

Intervention / Treatment
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* Procedure: Personalized risk assessment
* Procedure: genetic counseling intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Personalized risk assessment|nan|
|Procedure: genetic counseling intervention|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict |  |  | 
| Knowledge of menopause and menopausal therapy |  |  | 
| Satisfaction with counseling intervention |  |  | 
| Medication usage |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived risk of breast cancer, heart disease, osteoporosis |  |  | 
| Worry about breast cancer, heart disease, osteoporosis |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, genetic counseling, breast cancer, tamoxifen, chemoprevention