title: Randomized controlled trial of a psychosocial telephone counseling intervention in BRCA1 and BRCA2 mutation carriers.
abstract: BACKGROUND
  Responses following BRCA1/2 genetic testing are relevant for the comprehension of risk status and may play a role in risk management decision making. The objective of this study was to evaluate a psychosocial telephone counseling (PTC) intervention delivered to BRCA1/2 mutation carriers following standard genetic counseling (SGC). We examined the effect of the intervention on distress and the concerns related to genetic testing.
  
  
  METHODS
  This prospective randomized clinical trial included 90 BRCA1/2 mutation carriers. We measured anxiety, depression, and genetic testing distress outcomes at intervention baseline and 6 and 12 months following disclosure. We evaluated the effects of SGC versus SGC plus PTC on psychological outcomes using intention-to-treat analyses through generalized estimating equations.
  
  
  RESULTS
  At 6 months, PTC reduced depressive symptoms (Z = -2.25, P = 0.02) and genetic testing distress (Z = 2.18, P = 0.02) compared with SGC. Furthermore, women in the intervention condition reported less clinically significant anxiety at 6 months (chi(2)(1) = 4.11, P = 0.04) than women who received SGC. We found no differences in outcomes between the intervention groups at the 12-month follow-up.
  
  
  CONCLUSIONS
  As an adjunct to SGC, PTC delivered following disclosure of positive BRCA1/2 test results seems to offer modest short-term benefits for distress and anxiety. These results build upon a growing literature of psychosocial interventions for BRCA1/2 carriers and, given the potential impact of affect on risk management decision making, suggest that some carriers may derive benefits from adjuncts to traditional genetic counseling.
authors.affiliation: Department of Oncology and The Fisher Centerfor Familial Cancer Research, Lombardi Comprehensive Cancer Center, Georgetown University, 3300 Whitehaven Street, Northwest, Suite 4100, Washington, DC 20007, USA. kdg9@georgetown.edu
authors.forename: Kristi D
authors.initials: KD
authors.lastname: Graves
authors.forename: Lari
authors.initials: L
authors.lastname: Wenzel
authors.forename: Marc D
authors.initials: MD
authors.lastname: Schwartz
authors.forename: George
authors.initials: G
authors.lastname: Luta
authors.forename: Paul
authors.initials: P
authors.lastname: Wileyto
authors.forename: Steven
authors.initials: S
authors.lastname: Narod
authors.forename: Beth N
authors.initials: BN
authors.lastname: Peshkin
authors.forename: Alfred
authors.initials: A
authors.lastname: Marcus
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Susan Powell
authors.initials: SP
authors.lastname: Emsbo
authors.forename: Denise
authors.initials: D
authors.lastname: Barnes
authors.forename: Chanita Hughes
authors.initials: CH
authors.lastname: Halbert
mesh_terms: D005260:Female; D019398:Genes, BRCA1; D024522:Genes, BRCA2; D005817:Genetic Counseling / Q000379:methods*; D020022:Genetic Predisposition to Disease / Q000523:psychology*; D006801:Humans; D009154:Mutation; D013689:Telephone