Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations - Full Text View

Sponsor:	Lombardi Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00416754

Purpose

RATIONALE: Genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment.

PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for BRCA1 or BRCA2 mutations.

Condition	Intervention
Breast Cancer	Other: counseling intervention

Study Type:	Interventional
Study Design:	Screening, Randomized
Official Title:	Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer Help Me Understand Genetics

MedlinePlus related topics: Breast Cancer Cancer Genetic Counseling

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:

950

Detailed Description:

OBJECTIVES:

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 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.

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

Eligibility

Ages Eligible for Study:	25 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416754

Sponsors and Collaborators

Lombardi Cancer Research Center

National Cancer Institute (NCI)

Investigators

Investigator:

Tiffani DeMarco, MS

Lombardi Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000450754, GUMC-2000-305
Study First Received:	December 27, 2006
Last Updated:	March 7, 2009
ClinicalTrials.gov Identifier:	NCT00416754 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010