title: Parallel multicentre randomised trial of a clinical trial question prompt list in patients considering participation in phase 3 cancer treatment trials.
abstract: To evaluate the effect of a clinical trial question prompt list in patients considering enrolment in cancer treatment trials.
  
  
  
  Tertiary cancer referral hospitals in three state capital cities in Australia.
  
  
  
  88 patients with cancer attending three cancer centres in Australia, who were considering enrolment in phase 3 treatment trials, were invited to enrol in an unblinded randomised trial of provision of a clinical trial question prompt list (QPL) before consenting to enrol in the treatment trial.
  
  
  
  We developed and pilot tested a targeted QPL for patients with cancer considering clinical trial participation (the clinical trial QPL). Consenting patients were randomised to receive the clinical trial QPL or not before further discussion with their oncologist and/or trial nurse about the treatment trial.
  
  
  
  Questionnaires were completed at baseline and within 3 weeks of deciding on treatment trial participation.
  
  
  
  scores on the Quality of Informed Consent questionnaire (QuIC).
  
  
  
  88 patients of 130 sought for the study were enrolled (43 males), and 45 received the clinical trial QPL. 49% of trials were chemotherapy interventions for patients with advanced disease, 35% and 16% were surgical adjuvant and radiation adjuvant trials respectively. 70 patients completed all relevant questionnaires. 28 of 43 patients in the control arm compared with 39 of 45 patients receiving the clinical trial QPL completed the QuIC (p=0.0124). There were no significant differences in the QuIC scores between the randomised groups (QuIC part A p=0.08 and QuIC part B p=0.92). There were no differences in patient satisfaction with decisions or in anxiety levels between the randomised groups.
  
  
  
  Use of a question prompt list did not significantly change the QuIC scores in this randomised trial. ANZCTR 12606000214538 prospectively registered 31/5/2006.
  
  
  
  Results, ACTRN12606000214538.
authors.affiliation: Sydney Cancer Centre, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.|Department of Cancer Medicine, University of Sydney, Camperdown, New South Wales, Australia.
authors.forename: Martin H N
authors.initials: MH
authors.lastname: Tattersall
authors.affiliation: Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.|Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Jefford
authors.affiliation: National Health and Research Council, Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Martin
authors.affiliation: Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia.
authors.forename: Ian
authors.initials: I
authors.lastname: Olver
authors.affiliation: Melanoma Institute Australia, Royal Prince Alfred Hospital and the University of Sydney, Camperdown, New South Wales, Australia.
authors.forename: John F
authors.initials: JF
authors.lastname: Thompson
authors.affiliation: Department of Health Behaviour and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.
authors.forename: Richard F
authors.initials: RF
authors.lastname: Brown
authors.affiliation: Centre for Medical Psychology and Evidence-Based Decision-Making, School of Psychology, University of Sydney, Camperdown, New South Wales, Australia.
authors.forename: Phyllis N
authors.initials: PN
authors.lastname: Butow
mesh_terms: D000368:Aged; D001315:Australia; D035843:Biomedical Research; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D010358:Patient Participation; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires; D062606:Tertiary Care Centers
keywords: Informed Consent Questionnaire; Question Prompt List