title: Does rapid genetic counseling and testing in newly diagnosed breast cancer patients cause additional psychosocial distress? results from a randomized clinical trial.
abstract: OBJECTIVE
  Female breast cancer patients carrying a BRCA1/2 mutation have an increased risk of second primary breast cancer. Rapid genetic counseling and testing (RGCT) before surgery may influence choice of primary surgical treatment. In this article, we report on the psychosocial impact of RGCT.
  
  
  METHODS
  Newly diagnosed breast cancer patients at risk for carrying a BRCA1/2 mutation were randomized to an intervention group (offer of RGCT) or a usual care control group (ratio 2:1). Psychosocial impact and quality of life were assessed with the Impact of Events Scale, Hospital Anxiety and Depression Scale, Cancer Worry Scale, and the EORTC QLQ-C30 and QLQ-BR23. Assessments took place at study entry and at 6- and 12-month follow-up visits.
  
  
  RESULTS
  Between 2008 and 2010, 265 patients were recruited into the study. Completeness of follow-up data was more than 90%. Of the 178 women in the intervention group, 177 had genetic counseling, of whom 71 (40%) had rapid DNA testing and 59 (33%) received test results before surgery. Intention-to-treat and per-protocol analyses showed no statistically significant differences between groups over time in any of the psychosocial outcomes.
  
  
  CONCLUSIONS
  In this study, RGCT in newly diagnosed breast cancer patients did not have any measurable adverse psychosocial effects.
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.|Division of Biomedical Genetics, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Marijke R
authors.initials: MR
authors.lastname: Wevers
authors.affiliation: Division of Biomedical Genetics, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Margreet G E M
authors.initials: MG
authors.lastname: Ausems
authors.affiliation: Family Cancer Clinic, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Senno
authors.initials: S
authors.lastname: Verhoef
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Eveline M A
authors.initials: EM
authors.lastname: Bleiker
authors.affiliation: Department of Psychosocial Counseling, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Daniela E E
authors.initials: DE
authors.lastname: Hahn
authors.affiliation: Division of Biomedical Genetics, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Titia
authors.initials: T
authors.lastname: Brouwer
authors.affiliation: Family Cancer Clinic, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Frans B L
authors.initials: FB
authors.lastname: Hogervorst
authors.affiliation: Division of Biomedical Genetics, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Rob B
authors.identifier: http://orcid.org/0000-0002-0018-1089
authors.initials: RB
authors.lastname: van der Luijt
authors.affiliation: Division of Surgery, Diakonessen Hospital, Utrecht, The Netherlands.
authors.forename: Thijs
authors.initials: T
authors.lastname: van Dalen
authors.affiliation: Division of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: Evert B
authors.initials: EB
authors.lastname: Theunissen
authors.affiliation: Division of Surgery, Meander Medical Center, Amersfoort, The Netherlands.
authors.forename: Bart
authors.initials: B
authors.lastname: van Ooijen
authors.affiliation: Division of Surgery, Rivierenland Hospital, Tiel, The Netherlands.
authors.forename: Marnix A
authors.initials: MA
authors.lastname: de Roos
authors.affiliation: Division of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Borgstein
authors.affiliation: Division of Surgery, St. Lucas Andreas Hospital, Amsterdam, The Netherlands.
authors.forename: Bart C
authors.initials: BC
authors.lastname: Vrouenraets
authors.affiliation: Division of Surgery, Tergooi Hospitals, Blaricum, The Netherlands.
authors.forename: Eline
authors.initials: E
authors.lastname: Vriens
authors.affiliation: Division of Surgery, Gelre Hospitals, Apeldoorn, The Netherlands.
authors.forename: Wim H
authors.initials: WH
authors.lastname: Bouma
authors.affiliation: Division of Surgery, Kennemer Gasthuis, Haarlem, The Netherlands.
authors.forename: Herman
authors.initials: H
authors.lastname: Rijna
authors.affiliation: Division of Surgery, Zuwe Hofpoort Hospital, Woerden, The Netherlands.
authors.forename: Johannes P
authors.initials: JP
authors.lastname: Vente
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Jacobien M
authors.identifier: http://orcid.org/0000-0003-2042-9245
authors.initials: JM
authors.lastname: Kieffer
authors.affiliation: Department of Psychology, Reykjavik University, Reykjavik, Iceland.
authors.forename: Heiddis B
authors.initials: HB
authors.lastname: Valdimarsdottir
authors.affiliation: Division of Surgery, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Emiel J Th
authors.initials: EJ
authors.lastname: Rutgers
authors.affiliation: Division of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Arjen J
authors.initials: AJ
authors.lastname: Witkamp
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Neil K
authors.initials: NK
authors.lastname: Aaronson
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000175:diagnosis / Q000523:psychology*; D005260:Female; D019398:Genes, BRCA1; D024522:Genes, BRCA2; D005817:Genetic Counseling / Q000523:psychology*; D005820:Genetic Testing; D006801:Humans; D008875:Middle Aged; D013997:Time Factors; D055815:Young Adult