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Completed

NCT Number: NCT00349011

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

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.

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Key information

Conditions

Menopause Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale Cancer Genetic Counseling, Yale Cancer Center, Yale University School of Medicine

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized risk assessment

Procedure

genetic counseling intervention

Procedure

Primary outcomes

  1. Decisional conflict

  2. Knowledge of menopause and menopausal therapy

  3. Satisfaction with counseling intervention

  4. Medication usage

Secondary outcomes

  1. Perceived risk of breast cancer, heart disease, osteoporosis

  2. Worry about breast cancer, heart disease, osteoporosis

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Massachusetts General Hospital
  • Stony Brook University
  • Women and Infants Hospital of Rhode Island

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Jul 6, 2006
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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