title: Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates.
abstract: Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials.
authors.affiliation: Department of Oncology, Institute of Clinical Sciences, Lund University, Department of Oncology, Skåne University Hospital, Lund, Sweden. pia.dellson@med.lu.se
authors.forename: P
authors.initials: P
authors.lastname: Dellson
authors.forename: M
authors.initials: M
authors.lastname: Nilbert
authors.forename: P-O
authors.initials: PO
authors.lastname: Bendahl
authors.forename: P
authors.initials: P
authors.lastname: Malmström
authors.forename: C
authors.initials: C
authors.lastname: Carlsson
mesh_terms: D000368:Aged; D001943:Breast Neoplasms / Q000523:psychology; D002986:Clinical Trials as Topic; D003142:Communication; D005260:Female; D017144:Focus Groups; D006801:Humans; D007258:Informed Consent / Q000523:psychology / Q000592:standards*; D008875:Middle Aged; D010344:Patient Advocacy; D010353:Patient Education as Topic; D036301:Qualitative Research; D011795:Surveys and Questionnaires