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Decision-making Regarding Prophylactic Mastectomy and Oophorectomy in Women Seeking Genetic Counseling and Testing for BRCA1/2 Mutations


N/A
25 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Ovarian Cancer

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Trial Information

Decision-making Regarding Prophylactic Mastectomy and Oophorectomy in Women Seeking Genetic Counseling and Testing for BRCA1/2 Mutations


For women with a strong family history of breast/ovarian cancer, few options exist for
primary prevention of these cancers other than prophylactic surgery, or surgical removal of
noncancerous organs in order to prevent occurrence of the disease. The primary aim of the
study is to describe the stages of intention to undergo prophylactic mastectomy and/or
oophorectomy among women seeking genetic testing for inherited BRCA1 and BRCA2 mutations,
and to identify factors that influence stages of intention regarding prophylactic surgery.
To achieve these aims, 626 women undergoing genetic counseling and testing for inherited
breast ovarian cancer risk will be assessed before their first genetic counseling session
and three times (1 week, 6 months and 12 months) in the year following notification of their
genetic test results.


Inclusion Criteria:



- Female gender

- age 25 and above

- a personal or family history of breast and/or ovarian cancer showing clinical
features associated with increased risk of carrying a BRCA1/2 mutation (e.g., breast
and ovarian cancer on the same side of the family, early age of onset, multiple
primaries in the same individual) or having a first-degree relative with a known
BRCA1 or BRCA2 mutation.

Exclusion Criteria:

- Male gender

- age less than 25 years

- unable to provide meaningful informed consent due to physical, cognitive or
psychiatric disability

- non-English speaking

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Primary outcome of the study is stage of intention to undergo prophylactic surgery. Outcome variable consists of 6 rank-ordered, qualitatively distinct stages (see Measures) ranging from Precontemplation (no intention) to Action (intention carried out).

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Wendy Lichtenthal, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

03-001

NCT ID:

NCT00579007

Start Date:

March 2003

Completion Date:

March 2013

Related Keywords:

  • Breast Cancer
  • Ovarian Cancer
  • Prophylactic Mastectomy
  • Prophylactic Oophorectomy
  • Breast Neoplasms
  • Ovarian Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021