title: Longitudinal changes in patient distress following interactive decision aid use among BRCA1/2 carriers: a randomized trial.
abstract: Increasingly, women with a strong family history of breast cancer are seeking genetic testing as a starting point to making significant decisions regarding management of their cancer risks. Individuals who are found to be carriers of a BRCA1 or BRCA2 mutation have a substantially elevated risk for breast cancer and are frequently faced with the decision of whether to undergo risk-reducing mastectomy.
  
  
  
  In order to provide BRCA1/2 carriers with ongoing decision support for breast cancer risk management, a computer-based interactive decision aid was developed and tested against usual care in a randomized controlled trial.
  
  
  
  . Following genetic counseling, 214 female (aged 21-75 years) BRCA1/2 mutation carriers were randomized to usual care (UC; n = 114) or usual care plus decision aid (DA; n = 100) arms. UC participants received no further intervention; DA participants were sent the CD-ROM-based decision aid to view at home.
  
  
  
  The authors measured general distress, cancer-specific distress, and genetic testing-specific distress at 1-, 6-, and 12-month follow-up time points postrandomization.
  
  
  
  Longitudinal analyses revealed a significant longitudinal impact of the DA on cancer-specific distress (B = 5.67, z = 2.81, P = 0.005), which varied over time (DA group by time; B = -2.19, z = -2.47, P = 0.01), and on genetic testing-specific distress (B = 5.55, z = 2.46, P = 0.01), which also varied over time (DA group by time; B = -2.46, z = -2.51, P = 0.01). Individuals randomized to UC reported significantly decreased distress in the month following randomization, whereas individuals randomized to the DA maintained their postdisclosure distress over the short term. By 12 months, the overall decrease in distress between the 2 groups was similar.
  
  
  
  This report provides new insight into the long-term longitudinal effects of DAs.
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC (GWH, K-GL, TD, BNP, CF, MDS)
authors.forename: Gillian W
authors.initials: GW
authors.lastname: Hooker
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC (GWH, K-GL, TD, BNP, CF, MDS)
authors.forename: Kara-Grace
authors.initials: KG
authors.lastname: Leventhal
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC (GWH, K-GL, TD, BNP, CF, MDS)
authors.forename: Tiffani
authors.initials: T
authors.lastname: DeMarco
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC (GWH, K-GL, TD, BNP, CF, MDS)
authors.forename: Beth N
authors.initials: BN
authors.lastname: Peshkin
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC (GWH, K-GL, TD, BNP, CF, MDS)
authors.forename: Clinton
authors.initials: C
authors.lastname: Finch
authors.affiliation: Section of Genetics and Metabolism, Albany Medical Center, Albany, NY (EW)
authors.forename: Erica
authors.initials: E
authors.lastname: Wahl
authors.affiliation: Greenebaum Cancer Center, University of Maryland, Baltimore, MD (JRJ)
authors.forename: Jessica Rispoli
authors.initials: JR
authors.lastname: Joines
authors.affiliation: Department of Genetic and Genomic Sciences, Mount Sinai School of Medicine, New York, NY (KB)
authors.forename: Karen
authors.initials: K
authors.lastname: Brown
authors.affiliation: Department of Oncological Sciences, Mount Sinai School of Medicine, New York, NY (HV)
authors.forename: Heiddis
authors.initials: H
authors.lastname: Valdimarsdottir
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC (GWH, K-GL, TD, BNP, CF, MDS)
authors.forename: Marc D
authors.initials: MD
authors.lastname: Schwartz
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000235:genetics* / Q000523:psychology* / Q000601:surgery; D003658:Decision Making, Computer-Assisted; D003661:Decision Support Techniques; D005260:Female; D019398:Genes, BRCA1; D024522:Genes, BRCA2; D005817:Genetic Counseling / Q000523:psychology*; D006801:Humans; D008137:Longitudinal Studies; D008327:Mammography; D008408:Mastectomy; D008875:Middle Aged; D015999:Multivariate Analysis; D009518:New York / Q000453:epidemiology; D010353:Patient Education as Topic; D011594:Psychometrics; D018570:Risk Assessment; D013315:Stress, Psychological; D011795:Surveys and Questionnaires; D013997:Time Factors; D055815:Young Adult