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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations

NCT00416754

Breast Cancer

COMPLETED NA

Cluster Randomized Trial Comparing Interventions to Enhance Genetic Counseling Among Breast Cancer Patients

NCT01789684

Breast Cancer

COMPLETED NA

Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children

NCT00685256

Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2)

COMPLETED PHASE3

Menopausal Symptoms in Women With Breast Cancer or At High Risk of Breast Cancer Treated on Another Clinical Trial

NCT00666913

Breast Cancer Hot Flashes

COMPLETED

Genetic Risk Estimation of Breast Cancer Prior to Preventive Medication Uptake

NCT02517593

Breast Cancer

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopause

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Personalized risk assessment

Intervention Type PROCEDURE

genetic counseling intervention

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes