title: Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial.
abstract: OBJECTIVE
  Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals. We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction.
  
  
  METHODS
  We conducted a pilot randomized controlled trial (RCT) where participants were randomly assigned to the intervention with routine education or routine education alone. The outcomes evaluated were decisional conflict, decision self-efficacy, satisfaction with information, perceived involvement in care, and uptake of reconstruction following surgical consultation. Trial feasibility and acceptability were evaluated, and effect sizes were calculated to determine the primary outcome for the full-scale RCT.
  
  
  RESULTS
  Of the 41 patients enrolled, recruitment rate was 72 %, treatment fidelity was 98 %, and retention rate was 95 %. The Cohen's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education (0.69, 95 % CI = 0.02-1.42), while the effect sizes of increase in decision self-efficacy (0.05, 95 % CI = -0.60-0.71) and satisfaction with information (0.11, 95 % CI = -0.53-0.76) were small. A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction (14/20 or 70 %) compared to the intervention group (8/21 or 38 %) P = 0.06.
  
  
  CONCLUSIONS
  A pre-consultation educational group intervention improves patients' shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.
authors.affiliation: Division of Plastic & Reconstructive Surgery, Breast Reconstruction Program, University Health Network, 8N871, 200 Elizabeth St., Toronto, ON, M5G 2C4, Canada.
authors.forename: Natalie
authors.initials: N
authors.lastname: Causarano
authors.forename: Jennica
authors.initials: J
authors.lastname: Platt
authors.forename: Nancy N
authors.initials: NN
authors.lastname: Baxter
authors.forename: Shaghayegh
authors.initials: S
authors.lastname: Bagher
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Jones
authors.forename: Kelly A
authors.initials: KA
authors.lastname: Metcalfe
authors.forename: Stefan O P
authors.initials: SO
authors.lastname: Hofer
authors.forename: Anne C
authors.initials: AC
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: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000601:surgery*; D003657:Decision Making; D003661:Decision Support Techniques; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D016462:Mammaplasty / Q000193:education*; D008408:Mastectomy; D008875:Middle Aged; D010353:Patient Education as Topic; D010817:Physician-Patient Relations; D010865:Pilot Projects; D012017:Referral and Consultation; D020377:Self Efficacy; D011795:Surveys and Questionnaires