title: Evaluation of an educational program to improve communication with patients about early-phase trial participation.
abstract: BACKGROUND
  Discussing early-phase cancer trials is challenging; most offer little personal benefit to patients with life-limiting illnesses who frequently have a poor understanding of and misconceptions about the therapeutic aims. We evaluated an evidence-based training program aimed at enhancing communication.
  
  
  METHODS
  Prior to and after the intervention, 47 health care professionals (HCPs) experienced in early-phase trial recruitment were audio taped discussing trials with patient simulators who completed postinterview evaluations. Coders rated the interviews for the presence of information areas required to elicit ethical consent. HCPs reported their self-confidence on 15 different aspects of trial discussion.
  
  
  RESULTS
  Significant objective and subjective improvements in communication were found after the workshop. Analyses of audio tapes showed positive shifts in: establishing the patient's knowledge of their prognosis (odds ratio [OR], 2.7; p = .002), discussing symptomatic care (OR, 3.8; p < .001), the aims of the trial (OR, 2.6; p =.002), and the unlikelihood of medical benefit (OR, 3.0; p = .021). Patient simulator ratings showed improvements in: the awareness of palliative care and symptom control (OR, 2.1; p = .004), the voluntariness of participation (OR, 3.7; p = .015), the opportunity to ask questions (OR, 2.9; p = .044), and the time to consider participation (OR, 6.1; p = .009). HCPs' self-confidence increased significantly for all 15 items (OR range, 1.5-2.9; p ≤ .001).
  
  
  CONCLUSIONS
  This short, intensive workshop changed communication skills competency and self-efficacy in ways likely to promote valid, ethically informed consent from patients contemplating trial entry.
authors.affiliation: Sussex Cancer Research UK Psychosocial Oncology Group, Brighton & Sussex, Medical School, University of Sussex, Falmer, Brighton, BN1 9QG, UK.
authors.forename: Lesley J
authors.initials: LJ
authors.lastname: Fallowfield
authors.forename: Ivonne
authors.initials: I
authors.lastname: Solis-Trapala
authors.forename: Valerie A
authors.initials: VA
authors.lastname: Jenkins
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics; D006801:Humans; D010353:Patient Education as Topic / Q000941:ethics; D010358:Patient Participation / Q000523:psychology