title: Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.
abstract: BACKGROUND
  The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients.
  
  
  METHODS
  This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.
  
  
  METHODS
  The University Health Network, a tertiary care cancer center in Toronto, Canada.
  
  
  METHODS
  Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction.
  
  
  METHODS
  We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient.
  
  
  METHODS
  Usual care includes access to an informational booklet, website, and patient volunteer if desired.
  
  
  RESULTS
  Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial.
  
  
  CONCLUSIONS
  Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013.
  
  
  BACKGROUND
  NCT01857882.
authors.affiliation: UHN Breast Restoration Program, Division of Plastic and Reconstructive Surgery, 8N 871, 200 Elizabeth Street, Toronto, ON M5G 2C4, Canada.
authors.forename: Jennica
authors.initials: J
authors.lastname: Platt
authors.forename: Nancy
authors.initials: N
authors.lastname: Baxter
authors.forename: Jennifer
authors.initials: J
authors.lastname: Jones
authors.forename: Kelly
authors.initials: K
authors.lastname: Metcalfe
authors.forename: Natalie
authors.initials: N
authors.lastname: Causarano
authors.forename: Stefan O P
authors.initials: SO
authors.lastname: Hofer
authors.forename: Anne
authors.initials: A
authors.lastname: O'Neill
authors.forename: Terry
authors.initials: T
authors.lastname: Cheng
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Starenkyj
authors.forename: Toni
authors.initials: T
authors.lastname: Zhong
mesh_terms: D019928:Breast Implantation; D001943:Breast Neoplasms / Q000175:diagnosis / Q000523:psychology / Q000601:surgery*; D002985:Clinical Protocols; D003657:Decision Making; D005240:Feasibility Studies; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008408:Mastectomy; D009864:Ontario; D010353:Patient Education as Topic; D010358:Patient Participation; D017060:Patient Satisfaction; D010865:Pilot Projects; D012017:Referral and Consultation; D012107:Research Design; D020377:Self Efficacy; D016896:Treatment Outcome