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Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing

25 Years
75 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing


- Evaluate the impact of BRCA1/BRCA2 testing among members of hereditary breast-ovarian
cancer families.

- Evaluate the long-term impact of genetic counseling and testing on psychosocial and
behavioral outcomes.

- Evaluate the relative impact of standard genetic counseling (SGC) versus SGC plus the
interactive decision-aid (IDA) on medical decision-making.

- Evaluate the relative impact of SGC vs SGC + IDA on psychological well-being.

- Explore the mechanisms by which the SGC + IDA intervention impacts on psychosocial and
behavioral outcomes.

OUTLINE: This is a multicenter study.

Eligible women are asked to participate in a baseline telephone interview over 30 minutes
and then invited to a genetic counseling session over 1.5-2 hours that includes information
about BRCA1/2 testing. Patients are then offered BRCA1/2 testing, and the test results
(i.e., mutation carrier vs noncarrier) are presented at a subsequent in-person individual
genetic counseling session over 1.5-2 hours. Patients who tested positive for BRCA1 or 2
mutation are randomized to 1 of 2 counseling arms. All other patients proceed to follow up.

- Arm I (standard genetic counseling): No further counselor-initiated contact is

- Arm II (individualized decision aid): Patients are asked to view an interactive
computer program that is designed to help the patients make medical decisions based on
their breast cancer risk.

Outcome assessments, including quality of life assessment, are conducted at 2, 6, and 12

PROJECTED ACCRUAL: A total of 950 patients will be accrued for this study.

Inclusion Criteria


- Members of hereditary breast/ovarian cancer families (in which there is at least a
10-20% prior probability of a BRCA1/2 mutation) OR who have a first-degree relative
with a known BRCA1 or BRCA2 mutation

- Prior diagnosis of breast cancer allowed

- Must not be undergoing active treatment

- Patients with prior bilateral mastectomy are eligible for study but not eligible
for randomization


- Female only

- No psychiatric or cognitive disorder that would preclude giving informed consent


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

patient satisfaction

Outcome Description:

subjects will complete questionnaires re; genetic counseling experience

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Marc Schwartz, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lombardi Cancer Research Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2000

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms