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

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Women and Infants Hospital of Rhode Island
Stony Brook University
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00349011
First received: July 5, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Ages Eligible for Study:   40 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00349011     History of Changes
Other Study ID Numbers: Komen BCTR0100202
Study First Received: July 5, 2006
Last Updated: July 5, 2006
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014