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A Randomized Study of Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing

18 Years
Not Enrolling
Breast Cancer, Ovarian Cancer

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Trial Information

A Randomized Study of Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing

- Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or
BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of
developing breast and ovarian cancer.

- Patients participating in this study have either: 1) expressed an interest in testing
for an underlying genetic factor that may account for the breast or ovarian cancer in
their family; 2) have at least one relative that has been found to have a BRCA1 or
BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that
is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or
has at least one close relative with a history of breast or ovarian cancer and are a
member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.

- Patients will be randomized into one of two counseling groups. Two visits with a
specially trained genetic counselor or nurse in conjunction with a medical oncologist
and/or a medical specialist will be done in which information will be given either
about genetic counseling or enhanced informed consent. These visits will be audio-taped
to monitor how the project staff is covering the important information about testing.

- Throughout this study patients will be asked to complete questionnaires and
psychological measures. These forms will be completed before and after the first
visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and
12 months.

- In addition 30 women will be asked to complete a 20-30 minute telephone interview with
the program psychologist.

Inclusion Criteria:

- 18 years of age or older

- Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been
identified, whether or not the individual has had cancer herself; written
documentation of the family mutation must be available for laboratory purposes during
the testing process.

- Personal and/or family history of breast/ovarian/other cancer consistent with BRCA
1/2 heredity with posterior probability of carrying an altered gene

- Documentation of key family member cancer diagnoses is required

Exclusion Criteria:

- Males, will be offered BRCA 1/2 testing through other protocols

- Individuals unable to speak or write English

- Already participated in a genetic counseling program for BRCA1 or BRCA2 testing

- Life expectancy of less than 12 months.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

To determine if genetic counseling yields better psycho-social and medical care utilization outcomes, compared to a medical model of informed consent for genetic testing.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Judy Garber, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

July 1998

Completion Date:

June 2005

Related Keywords:

  • Breast Cancer
  • Ovarian Cancer
  • Genetic testing
  • BRCA1 gene
  • BRCA2 gene
  • Counseling interventions
  • Genetic counseling
  • Breast Neoplasms
  • Disease Susceptibility
  • Ovarian Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617