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

Not Applicable

Completed

• Conditions: Menopause

• Registration Number: NCT00349011
• Lead Sponsor: Yale University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2002-08
• Study Completion: 2004-03
• Study First Submitted: 2006-07-05
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Medication usage
Decisional conflict
Knowledge of menopause and menopausal therapy
Satisfaction with counseling intervention

Secondary Outcome Measures

Name	Time	Method
Perceived risk of breast cancer, heart disease, osteoporosis
Worry about breast cancer, heart disease, osteoporosis

Trial Locations

Locations (1)

Yale Cancer Genetic Counseling, Yale Cancer Center, Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States