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• 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.
  

  
  

  status:	active, not recruiting
  conditions:	Breast Cancer
  interventions:	counseling intervention
  phase:	N/A
  study type:	Interventional
  study design:	Screening, Randomized
  official title:	Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing

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

  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

  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:

  Tiffani DeMarco, MS, Lombardi Cancer Research Center

• More information

  Clinical trial summary from the National Cancer Institute's PDQ® database
  
  

  first received:	December 27, 2006
  last updated:	March 7, 2009
  ClinicalTrials.gov Identifier:	NCT00416754
  health authority:	United States: Federal Government

Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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