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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00349011
First Posted: July 6, 2006
Last Update Posted: July 6, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Massachusetts General Hospital
Women and Infants Hospital of Rhode Island
Stony Brook University
Information provided by:
Yale University
  Purpose
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.

Condition Intervention
Menopause Procedure: Personalized risk assessment Procedure: genetic counseling intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Menopausal Therapy in Women at Increased Risk for Breast Cancer: Does a Personalized Risk Assessment and Counseling Intervention Aid in Decision-Making?

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Decisional conflict
  • Knowledge of menopause and menopausal therapy
  • Satisfaction with counseling intervention
  • Medication usage

Secondary Outcome Measures:
  • Perceived risk of breast cancer, heart disease, osteoporosis
  • Worry about breast cancer, heart disease, osteoporosis

Estimated Enrollment: 60
Study Start Date: August 2002
Estimated Study Completion Date: March 2004
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349011


Locations
United States, Connecticut
Yale Cancer Genetic Counseling, Yale Cancer Center, Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Massachusetts General Hospital
Women and Infants Hospital of Rhode Island
Stony Brook University
Investigators
Principal Investigator: Ellen T. Matloff, M.S. Yale University
  More Information

ClinicalTrials.gov Identifier: NCT00349011     History of Changes
Other Study ID Numbers: Komen BCTR0100202
First Submitted: July 5, 2006
First Posted: July 6, 2006
Last Update Posted: July 6, 2006
Last Verified: July 2006

Keywords provided by Yale University:
menopause
genetic counseling
breast cancer
tamoxifen
chemoprevention

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases