title: Patient representatives' views on patient information in clinical cancer trials.
abstract: BACKGROUND
  Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials.
  
  
  METHODS
  Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis.
  
  
  RESULTS
  Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms.
  
  
  CONCLUSIONS
  The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.
authors.affiliation: Division of Oncology and Pathology, Institute of Clinical Sciences, Lund University, Medicon Village, Scheelevägen 8, S-22381, Lund, Sweden.
authors.forename: Pia
authors.initials: P
authors.lastname: Dellson
authors.affiliation: Division of Oncology and Pathology, Institute of Clinical Sciences, Lund University, Medicon Village, Scheelevägen 8, S-22381, Lund, Sweden.|Clinical Research Centre, Hvidovre Hospital, University of Copenhagen, Kettegård allé 30, 2650 Hvidovre, Copenhagen, Denmark.
authors.forename: Mef
authors.initials: M
authors.lastname: Nilbert
authors.affiliation: Division of Oncology and Pathology, Institute of Clinical Sciences, Lund University, Medicon Village, Scheelevägen 8, S-22381, Lund, Sweden. Christina.carlsson@med.lu.se.
authors.forename: Christina
authors.initials: C
authors.lastname: Carlsson
mesh_terms: D000368:Aged; D001294:Attitude to Health; D002986:Clinical Trials as Topic / Q000592:standards; D003071:Cognition; D015179:Colorectal Neoplasms / Q000523:psychology / Q000628:therapy*; D032882:Comprehension; D004644:Emotions; D005260:Female; D017144:Focus Groups; D006801:Humans; D007258:Informed Consent / Q000523:psychology; D008297:Male; D008875:Middle Aged; D010174:Pamphlets; D010344:Patient Advocacy / Q000523:psychology*; D010353:Patient Education as Topic / Q000379:methods / Q000592:standards*; D057240:Patient Preference; D010465:Perception; D058996:Quality Improvement
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