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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?


N/A
40 Years
N/A
Not Enrolling
Female
Menopause

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Outcome Measure:

Decisional conflict

Principal Investigator

Ellen T. Matloff, M.S.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

United States: Institutional Review Board

Study ID:

Komen BCTR0100202

NCT ID:

NCT00349011

Start Date:

August 2002

Completion Date:

March 2004

Related Keywords:

  • Menopause
  • menopause
  • genetic counseling
  • breast cancer
  • tamoxifen
  • chemoprevention
  • Breast Neoplasms

Name

Location

Yale Cancer Genetic Counseling, Yale Cancer Center, Yale University School of MedicineNew Haven, Connecticut  06510