title: "I didn't really understand it, I just thought it'd help": exploring the motivations, understandings and experiences of patients with advanced lung cancer participating in a non-placebo clinical IMP trial.
abstract: Few studies have explored in depth the experiences of patients with advanced cancer who are participating in clinical investigational medicinal product trials. However, integrated qualitative studies in such trials are needed to enable a broader evaluation of patient experiences in the trial, with important ethical and practical implications for the design and conduct of similar trials and treatment regimes in the future.
  
  
  
  Ten participants were recruited from the control and intervention arms of FRAGMATIC: a non-placebo trial for patients with advanced lung cancer. Participants were interviewed at up to three time points during their time in the trial. Interviews were analysed using Interpretive Phenomenological Analysis.
  
  
  
  Patients were motivated to join the trial out of hope of medical benefit and altruism. Understanding of randomisation was mixed and in some cases poor, as was appreciation of trial purpose and equipoise. The trial was acceptable to and evaluated positively by most participants; participants receiving the intervention focused on the potential treatment benefits they hoped they would receive, whilst participants in the control arm found alternative reasons, such as altruism, personal fulfilment and positive attention, to commit to and perceive benefits from the trial. However, whilst experiences were generally very positive, poor understanding, limited engagement with trial information and focus on treatment benefits amongst some participants give cause for concern.
  
  
  
  By exploring longitudinally the psychological, emotional and cognitive domains of trial participation, we consider potential harms and benefits of participation in non-placebo trials amongst patients with advanced lung cancer and identify several implications for future research with and care for patients with advanced cancer.
  
  
  
  ISRCTN80812769 . Registered on 8 July 2005.
authors.affiliation: Marie Curie Palliative Care Research Centre, Division of Population Medicine, Cardiff University School of Medicine, 1st Floor Neuadd Meirionydd, Heath Park Way, Cardiff, CF14 4YS, UK. harrope@cardiff.ac.uk.
authors.forename: Emily
authors.identifier: 0000-0003-2820-0023
authors.initials: E
authors.lastname: Harrop
authors.affiliation: Marie Curie Palliative Care Research Centre, Division of Population Medicine, Cardiff University School of Medicine, 1st Floor Neuadd Meirionydd, Heath Park Way, Cardiff, CF14 4YS, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Noble
authors.affiliation: School of Social Sciences, Cardiff University, 1-3 Museum Place, Cardiff, CF10 3BD, UK.
authors.forename: Michelle
authors.initials: M
authors.lastname: Edwards
authors.affiliation: Marie Curie Palliative Care Research Centre, Division of Population Medicine, Cardiff University School of Medicine, 1st Floor Neuadd Meirionydd, Heath Park Way, Cardiff, CF14 4YS, UK.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Sivell
authors.affiliation: Health and Care Research Wales Support Centre, Castelbridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK.
authors.forename: Barbara
authors.initials: B
authors.lastname: Moore
authors.affiliation: Marie Curie Palliative Care Research Centre, Division of Population Medicine, Cardiff University School of Medicine, 1st Floor Neuadd Meirionydd, Heath Park Way, Cardiff, CF14 4YS, UK.
authors.forename: Annmarie
authors.initials: A
authors.lastname: Nelson
mesh_terms: D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000523:psychology / Q000628:therapy*; D008297:Male; D009042:Motivation; D018579:Patient Selection
keywords: Consent; Lung cancer; Qualitative; RCT; Randomisation