title: A study of motivations and expectations of patients seen in phase 1 oncology clinics.
abstract: BACKGROUND
  To better inform clinical practice, this study was aimed at capturing patients' motivations for enrolling in phase 1 trials and at quantifying their expectations of the benefits, risks, and commitment associated with clinical trials and the impact of the initial consultation on their expectations.
  
  
  METHODS
  This was a single-center, prospective, quantitative study of newly referred adult patients considering their first phase 1 oncology trial. Participants completed questionnaires before they were seen and an abbreviated follow-up version after their consultation.
  
  
  RESULTS
  Questionnaires were completed by 396 (99%) and 301 (76%) before and after the clinic, respectively. Participants ranked the possibility of tumor shrinkage (84%) as the most important motivation for considering a phase 1 trial; this was followed by no alternative treatments (56%), their physician's recommendation (44%), and the fact that the research might benefit others (38%). When they were asked about the potential personal benefit, 43% predicted tumor shrinkage initially. After the consultation, this increased to 47%. Fourteen percent of patients expected a cure. When asked about risks, 71% of the participants expected moderate side effects. When asked about expectations of time commitments, a majority of patients did not anticipate weekly visits, although this was understood by 93% of patients after the consultation. Overall, patients were keen to consider trials and when asked before and after the consultation 72% and 84% were willing to enroll in studies, respectively.
  
  
  CONCLUSIONS
  This study reports that more than 80% of patients enroll in early-phase clinical oncology trials motivated by the potential of a clinical benefit, with approximately half expecting tumor shrinkage and approximately a tenth anticipating a cure. The typical phase 1 response rate is 4% to 20%, and this discrepancy exemplifies the challenges faced by patients and healthcare professionals during their interactions for phase 1 studies. Cancer 2016;122:3501-3508. © 2016 American Cancer Society.
authors.affiliation: Department of Medicine, Royal Marsden NHS Foundation Trust, London, United Kingdom.|Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Saoirse O
authors.initials: SO
authors.lastname: Dolly
authors.affiliation: Clinical R&D, Royal Marsden NHS Foundation Trust, London, United Kingdom.
authors.forename: Eleftheria
authors.initials: E
authors.lastname: Kalaitzaki
authors.affiliation: Department of Medicine, Royal Marsden NHS Foundation Trust, London, United Kingdom.|Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Martina
authors.initials: M
authors.lastname: Puglisi
authors.affiliation: Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Sarah
authors.initials: S
authors.lastname: Stimpson
authors.affiliation: Department of Medicine, Royal Marsden NHS Foundation Trust, London, United Kingdom.|Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Janet
authors.initials: J
authors.lastname: Hanwell
authors.affiliation: Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Sonia Serrano
authors.initials: SS
authors.lastname: Fandos
authors.affiliation: Department of Medicine, Royal Marsden NHS Foundation Trust, London, United Kingdom.|Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Sarah
authors.initials: S
authors.lastname: Stapleton
authors.affiliation: Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Thushara
authors.initials: T
authors.lastname: Ansari
authors.affiliation: Clinical R&D, Royal Marsden NHS Foundation Trust, London, United Kingdom.
authors.forename: Clare
authors.initials: C
authors.lastname: Peckitt
authors.affiliation: Department of Medicine, Royal Marsden NHS Foundation Trust, London, United Kingdom.|Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Stan
authors.initials: S
authors.lastname: Kaye
authors.affiliation: Department of Medicine, Royal Marsden NHS Foundation Trust, London, United Kingdom.|Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Juanita
authors.initials: J
authors.lastname: Lopez
authors.affiliation: Department of Medicine, Royal Marsden NHS Foundation Trust, London, United Kingdom.|Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Yap
authors.affiliation: Department of Medicine, Royal Marsden NHS Foundation Trust, London, United Kingdom.|Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Winette
authors.initials: W
authors.lastname: van der Graaf
authors.affiliation: Department of Medicine, Royal Marsden NHS Foundation Trust, London, United Kingdom.|Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Johann
authors.initials: J
authors.lastname: de Bono
authors.affiliation: Department of Medicine, Royal Marsden NHS Foundation Trust, London, United Kingdom.|Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.
authors.forename: Udai
authors.initials: U
authors.lastname: Banerji
keywords: cancer; oncology clinical trials; patient expectations; patient motivations; phase 1 trials