title: Behavioral and psychosocial effects of rapid genetic counseling and testing in newly diagnosed breast cancer patients: design of a multicenter randomized clinical trial.
abstract: BACKGROUND
  It has been estimated that between 5% and 10% of women diagnosed with breast cancer have a hereditary form of the disease, primarily caused by a BRCA1 or BRCA2 gene mutation. Such women have an increased risk of developing a new primary breast and/or ovarian tumor, and may therefore opt for preventive surgery (e.g., bilateral mastectomy, oophorectomy). It is common practice to offer high-risk patients genetic counseling and DNA testing after their primary treatment, with genetic test results being available within 4-6 months. However, some non-commercial laboratories can currently generate test results within 3 to 6 weeks, and thus make it possible to provide rapid genetic counseling and testing (RGCT) prior to primary treatment. The aim of this study is to determine the effect of RGCT on treatment decisions and on psychosocial health.
  
  
  METHODS
  In this randomized controlled trial, 255 newly diagnosed breast cancer patients with at least a 10% risk of carrying a BRCA gene mutation are being recruited from 12 hospitals in the Netherlands. Participants are randomized in a 2:1 ratio to either a RGCT intervention group (the offer of RGCT directly following diagnosis with tests results available before surgical treatment) or to a usual care control group. The primary behavioral outcome is the uptake of direct bilateral mastectomy or delayed prophylactic contralateral mastectomy. Psychosocial outcomes include cancer risk perception, cancer-related worry and distress, health-related quality of life, decisional satisfaction and the perceived need for and use of additional decisional counseling and psychosocial support. Data are collected via medical chart audits and self-report questionnaires administered prior to randomization, and at 6 month and at 12 month follow-up.
  
  
  CONCLUSIONS
  This trial will provide essential information on the impact of RGCT on the choice of primary surgical treatment among women with breast cancer with an increased risk of hereditary cancer. This study will also provide data on the psychosocial consequences of RGCT and of risk-reducing behavior.
  
  
  BACKGROUND
  The study is registered at the Netherlands Trial Register (NTR1493) and ClinicalTrials.gov (NCT00783822).
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, PO Box 90203, 1006 BE Amsterdam, The Netherlands.
authors.forename: Marijke R
authors.initials: MR
authors.lastname: Wevers
authors.forename: Margreet G E M
authors.initials: MG
authors.lastname: Ausems
authors.forename: Senno
authors.initials: S
authors.lastname: Verhoef
authors.forename: Eveline M A
authors.initials: EM
authors.lastname: Bleiker
authors.forename: Daniela E E
authors.initials: DE
authors.lastname: Hahn
authors.forename: Frans B L
authors.initials: FB
authors.lastname: Hogervorst
authors.forename: Rob B
authors.initials: RB
authors.lastname: van der Luijt
authors.forename: Heiddis B
authors.initials: HB
authors.lastname: Valdimarsdottir
authors.forename: Richard
authors.initials: R
authors.lastname: van Hillegersberg
authors.forename: Emiel J T H
authors.initials: EJ
authors.lastname: Rutgers
authors.forename: Neil K
authors.initials: NK
authors.lastname: Aaronson
mesh_terms: D000328:Adult; D019313:BRCA1 Protein / Q000235:genetics; D024682:BRCA2 Protein / Q000235:genetics; D001943:Breast Neoplasms / Q000235:genetics* / Q000523:psychology* / Q000601:surgery; D005500:Follow-Up Studies; D005817:Genetic Counseling / Q000523:psychology*; D005820:Genetic Testing / Q000523:psychology*; D006801:Humans; D008408:Mastectomy / Q000523:psychology; D008875:Middle Aged; D009154:Mutation; D010353:Patient Education as Topic; D040242:Risk Reduction Behavior
chemical_list: D019313:BRCA1 Protein; D024682:BRCA2 Protein; C551750:BRCA2 protein, human