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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00349011

Enrollment

Registered

2006-07-06

Start date

2002-08-31

Completion date

2004-03-31

Last updated

2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

menopause, genetic counseling, breast cancer, tamoxifen, chemoprevention

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.

Interventions

PROCEDUREPersonalized risk assessment

PROCEDUREgenetic counseling intervention

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Decisional conflict	—
Knowledge of menopause and menopausal therapy	—
Satisfaction with counseling intervention	—
Medication usage	—

Secondary

Measure	Time frame
Worry about breast cancer, heart disease, osteoporosis	—
Perceived risk of breast cancer, heart disease, osteoporosis	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026