title: Framing and personalizing informed consent to prevent negative expectations: An experimental pilot study.
abstract: OBJECTIVE
  Informing patients about medical treatments and their possible side effects is ethically and legally obligatory but may trigger negative expectations and nocebo-related side effects. This pilot study aims to investigate the effect of different informed consent procedures on treatment expectations for adjuvant breast cancer treatments (Study 1: endocrine therapy; Study 2: chemotherapy).
  
  
  METHODS
  Using an experimental 2-factorial design, healthy women were informed about endocrine therapy (n = 60) or chemotherapy (n = 64) within a hypothetical scenario. Information was framed with or without treatment benefit information and delivered in a personalized or standardized interaction. Primary outcomes were necessity-concern beliefs about the treatment and side-effect expectations, secondary outcomes were decisional conflicts.
  
  
  RESULTS
  In Study 1, side-effect expectations (η²p= .08) and decisional conflicts (η²p = .07) were lower when framed treatment information was given. Providing personalized information resulted in more functional necessity-concern beliefs (η²p = .06) and lower decisional conflicts (η²p = .07). Personalizing and framing of information resulted in more functional necessity-concern beliefs (η²p = .10) and lower decisional conflicts. In Study 2, necessity-concern beliefs were more functional with framing (η²p = .06). Participants in the personalized groups reported lower decisional conflicts (η²p = .06). No differences in side-effect expectations were revealed.
  
  
  CONCLUSIONS
  This is the first study to provide evidence for optimized treatment expectations through altered informed consent strategies. The results emphasize that framing and personalizing informed consent can positively influence treatment expectations and reduce decisional conflicts. However, generalizations are impaired by the study's pilot character. The potential to prevent nocebo responses in clinical practice should be analyzed. (PsycINFO Database Record
authors.affiliation: Institute of Psychology, Clinical Psychology and Psychotherapy, University of Hamburg.
authors.forename: Sarah R
authors.initials: SR
authors.lastname: Heisig
authors.affiliation: Institute of Psychology, Clinical Psychology and Psychotherapy, University of Hamburg.
authors.forename: Meike C
authors.initials: MC
authors.lastname: Shedden-Mora
authors.affiliation: Institute of Psychology, Clinical Psychology and Psychotherapy, University of Hamburg.
authors.forename: Pablo
authors.initials: P
authors.lastname: Hidalgo
authors.affiliation: Institute of Psychology, Clinical Psychology and Psychotherapy, University of Hamburg.
authors.forename: Yvonne
authors.identifier: 0000-0003-2191-0495
authors.initials: Y
authors.lastname: Nestoriuc
mesh_terms: D003657:Decision Making; D005260:Female; D006801:Humans; D007258:Informed Consent; D008875:Middle Aged; D010865:Pilot Projects