Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Screening	Closed	25 to 75	NCI	GUMC-2000-305 NCT00416754

Objectives

1. Evaluate the impact of BRCA1/BRCA2 testing among members of hereditary breast-ovarian cancer families.
2. Evaluate the long-term impact of genetic counseling and testing on psychosocial and behavioral outcomes.
3. Evaluate the relative impact of standard genetic counseling (SGC) versus SGC plus the interactive decision-aid (IDA) on medical decision-making.
4. Evaluate the relative impact of SGC vs SGC + IDA on psychological well-being.
5. Explore the mechanisms by which the SGC + IDA intervention impacts on psychosocial and behavioral outcomes.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

• See Disease Characteristics

Patient Characteristics:

• Female only
• No psychiatric or cognitive disorder that would preclude giving informed consent

Expected Enrollment

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

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 scheduled.
• 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 months.

Trial Contact Information

Trial Lead Organizations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Tiffani DeMarco, MS, Study coordinator		Ph: 202-444-4000

Registry Information
Official Title		Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing
Registered in ClinicalTrials.gov		NCT00416754
Date Submitted to PDQ		2005-09-12
Information Last Verified		2006-01-23
NCI Grant/Contract Number		CA51008, CA82346

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