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Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00416754
First received: December 27, 2006
Last updated: April 3, 2012
Last verified: April 2012
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • patient satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    subjects will complete questionnaires re; genetic counseling experience


Enrollment: 1109
Study Start Date: December 2000
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: counseling intervention
    subjects will receive genetic counseling
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
Georgetown University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Marc Schwartz, PhD 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

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00416754     History of Changes
Other Study ID Numbers: CDR0000450754, R01CA082346, P30CA051008, GUMC-2000-305
Study First Received: December 27, 2006
Last Updated: April 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013