Randomized trial of a decision aid for BRCA1/BRCA2 mutation carriers: impact on measures of decision making and satisfaction.
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.
Schwartz
Marc D
MD
Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
Valdimarsdottir
Heiddis B
HB
Department of Oncological Sciences, Mount Sinai School of Medicine.
DeMarco
Tiffani A
TA
Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
Peshkin
Beth N
BN
Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
Lawrence
William
W
Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
Rispoli
Jessica
J
Department of Genetics and Genomic Sciences, Mount Sinai School of Medicine.
Brown
Karen
K
Department of Genetics and Genomic Sciences, Mount Sinai School of Medicine.
Isaacs
Claudine
C
Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
O'Neill
Suzanne
S
Shelby
Rebecca
R
Department of Psychiatry and Behavioral Sciences, Duke University.
Grumet
Sherry C
SC
McGovern
Margaret M
MM
Department of Genetics and Genomic Sciences, Mount Sinai School of Medicine.
Garnett
Sarah
S
0000-0001-7552-0789
Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
Bremer
Heather
H
Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
Leaman
Suzanne
S
Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
O'Mara
Kathryn
K
Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
Kelleher
Sarah
S
Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
Komaridis
Kathryn
K
Cancer Control Program, Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University.
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