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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349011
• Other study ID #: Komen BCTR0100202
• Status: Completed
• Phase: N/A
• Start date: August 2002
• Est. completion date: March 2004

Study information

• Verified date: August 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Menopause

Intervention

Procedure:
• Personalized risk assessment

• genetic counseling intervention

Locations

Country	Name	City	State
United States	Yale Cancer Genetic Counseling, Yale Cancer Center, Yale University School of Medicine	New Haven	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	Massachusetts General Hospital, Stony Brook University, Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict
Primary	Knowledge of menopause and menopausal therapy
Primary	Satisfaction with counseling intervention
Primary	Medication usage
Secondary	Perceived risk of breast cancer, heart disease, osteoporosis
Secondary	Worry about breast cancer, heart disease, osteoporosis