title: Randomized trial of a decision aid for BRCA1/BRCA2 mutation carriers: impact on measures of decision making and satisfaction.
abstract: OBJECTIVE
  Genetic testing is increasingly part of routine clinical care for women with a family history of breast cancer. Given their substantially elevated risk for breast cancer, BRCA1/BRCA2 mutation carriers must make the difficult decision whether or not to opt for risk reducing mastectomy. To help BRCA1/2 carriers make this decision, the authors developed a computer-based interactive decision aid that was tested against usual care in a randomized controlled trial.
  
  
  METHODS
  After the completion of genetic counseling, 214 female (aged 21-75) BRCA1/BRCA2 mutation carriers were randomized to Usual Care (UC; N = 114) or Usual Care plus Decision Aid (DA; N = 100) arms. UC participants received no additional intervention. DA participants were sent the CD-ROM DA to view at home.
  
  
  METHODS
  The authors measured final management decision, decisional conflict, decisional satisfaction, and receipt of risk reducing mastectomy at 1-, 6-, and 12-months postrandomization.
  
  
  RESULTS
  Longitudinal analyses revealed that the DA was effective among carriers who were initially undecided about how to manage their breast cancer risk. Within this group, the DA led to an increased likelihood of reaching a management decision (OR = 3.09, 95% CI = 1.62, 5.90; p < .001), decreased decisional conflict (B = -.46, z = -3.1, p <002), and increased satisfaction (B = .27, z = 3.1, p = .002) compared to UC. Among carriers who had already made a management decision by the time of randomization, the DA had no benefit relative to UC.
  
  
  CONCLUSIONS
  These results demonstrate that BRCA1/BRCA2 mutation carriers who are having difficulty making a breast cancer risk management decision can benefit from adjunct decision support.
authors.affiliation: Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
authors.forename: Marc D
authors.initials: MD
authors.lastname: Schwartz
authors.affiliation: Department of Oncological Sciences, Mount Sinai School of Medicine.
authors.forename: Heiddis B
authors.initials: HB
authors.lastname: Valdimarsdottir
authors.affiliation: Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
authors.forename: Tiffani A
authors.initials: TA
authors.lastname: DeMarco
authors.affiliation: Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
authors.forename: Beth N
authors.initials: BN
authors.lastname: Peshkin
authors.affiliation: Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
authors.forename: William
authors.initials: W
authors.lastname: Lawrence
authors.affiliation: Department of Genetics and Genomic Sciences, Mount Sinai School of Medicine.
authors.forename: Jessica
authors.initials: J
authors.lastname: Rispoli
authors.affiliation: Department of Genetics and Genomic Sciences, Mount Sinai School of Medicine.
authors.forename: Karen
authors.initials: K
authors.lastname: Brown
authors.affiliation: Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
authors.forename: Claudine
authors.initials: C
authors.lastname: Isaacs
authors.forename: Suzanne
authors.initials: S
authors.lastname: O'Neill
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Shelby
authors.forename: Sherry C
authors.initials: SC
authors.lastname: Grumet
authors.affiliation: Department of Genetics and Genomic Sciences, Mount Sinai School of Medicine.
authors.forename: Margaret M
authors.initials: MM
authors.lastname: McGovern
authors.affiliation: Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
authors.forename: Sarah
authors.identifier: 0000-0001-7552-0789
authors.initials: S
authors.lastname: Garnett
authors.affiliation: Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
authors.forename: Heather
authors.initials: H
authors.lastname: Bremer
authors.affiliation: Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Leaman
authors.affiliation: Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
authors.forename: Kathryn
authors.initials: K
authors.lastname: O'Mara
authors.affiliation: Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
authors.forename: Sarah
authors.initials: S
authors.lastname: Kelleher
authors.affiliation: Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Komaridis
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000235:genetics*; D003657:Decision Making; D005260:Female; D019398:Genes, BRCA1; D024522:Genes, BRCA2; D005817:Genetic Counseling; D005820:Genetic Testing / Q000523:psychology*; D006801:Humans; D008408:Mastectomy; D008875:Middle Aged; D017060:Patient Satisfaction; D018570:Risk Assessment