title: Advance care planning--a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study.
abstract: BACKGROUND
  Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between patients, relatives and professional caregivers about patients' values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potential to improve current and future healthcare decision-making, provide patients with a sense of control, and improve their quality of life.
  
  
  METHODS
  We will study the effects of the ACP program Respecting Choices on the quality of life of patients with advanced lung or colorectal cancer. In a phase III multicenter cluster randomised controlled trial, 22 hospitals in 6 countries will be randomised. In the intervention sites, patients will be offered interviews with a trained facilitator. In the control sites, patients will receive care as usual. In total, 1360 patients will be included. All participating patients will be asked to complete questionnaires at inclusion, and again after 2.5 and 4.5 months. If a patient dies within a year after inclusion, a relative will be asked to complete a questionnaire on end-of-life care. Use of medical care will be assessed by checking medical files. The primary endpoint is patients' quality of life at 2.5 months post-inclusion. Secondary endpoints are the extent to which care as received is aligned with patients' preferences, patients' evaluation of decision-making processes, quality of end-of-life care and cost-effectiveness of the intervention. A complementary qualitative study will be carried out to explore the lived experience of engagement with the Respecting Choices program from the perspectives of patients, their Personal Representatives, healthcare providers and facilitators.
  
  
  CONCLUSIONS
  Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on average are younger and retain their mental capacity for a larger part of their disease trajectory, is an important next step in an era of increased focus on patient centered healthcare and shared decision-making.
  
  
  BACKGROUND
  International Standard Randomised Controlled Trial Number: ISRCTN63110516. Date of registration: 10/3/2014.
authors.affiliation: Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands. j.rietjens@erasmusmc.nl.
authors.forename: Judith A C
authors.initials: JA
authors.lastname: Rietjens
authors.affiliation: Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Ida J
authors.initials: IJ
authors.lastname: Korfage
authors.affiliation: International Observatory on the End-of-Life Care, Lancaster University, Lancaster, LA1 4YG, UK.
authors.forename: Lesley
authors.initials: L
authors.lastname: Dunleavy
authors.affiliation: International Observatory on the End-of-Life Care, Lancaster University, Lancaster, LA1 4YG, UK.
authors.forename: Nancy J
authors.initials: NJ
authors.lastname: Preston
authors.affiliation: Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Lea J
authors.initials: LJ
authors.lastname: Jabbarian
authors.affiliation: Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014, København, Denmark.
authors.forename: Caroline Arnfeldt
authors.initials: CA
authors.lastname: Christensen
authors.affiliation: University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.
authors.forename: Maja
authors.initials: M
authors.lastname: de Brito
authors.affiliation: Clinical and Descriptive Epidemiology Unit, ISPO Cancer Prevention and Research Institute, Florence, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bulli
authors.affiliation: School of Health Sciences, Sue Ryder Centre for the Study of Supportive, Palliative and End of Life Care, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
authors.forename: Glenys
authors.initials: G
authors.lastname: Caswell
authors.affiliation: University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.
authors.forename: Branka
authors.initials: B
authors.lastname: Červ
authors.affiliation: Julius Center for Health Sciences and Primary Care, Medical School of Utrecht University, Utrecht, The Netherlands.
authors.forename: Johannes
authors.initials: J
authors.lastname: van Delden
authors.affiliation: End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.|Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium.
authors.forename: Luc
authors.initials: L
authors.lastname: Deliens
authors.affiliation: Clinical and Descriptive Epidemiology Unit, ISPO Cancer Prevention and Research Institute, Florence, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gorini
authors.affiliation: Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014, København, Denmark.|The Research Unit, Department of Palliative Medicine, Bispebjerg / Frederiksberg Hospital, Bispebjerg Bakke 23, 2400, København, NV, Denmark.
authors.forename: Mogens
authors.initials: M
authors.lastname: Groenvold
authors.affiliation: End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.
authors.forename: Dirk
authors.initials: D
authors.lastname: Houttekier
authors.affiliation: Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Ingravallo
authors.affiliation: Julius Center for Health Sciences and Primary Care, Medical School of Utrecht University, Utrecht, The Netherlands.
authors.forename: Marijke C
authors.initials: MC
authors.lastname: Kars
authors.affiliation: University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.
authors.forename: Urška
authors.initials: U
authors.lastname: Lunder
authors.affiliation: Clinical and Descriptive Epidemiology Unit, ISPO Cancer Prevention and Research Institute, Florence, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Miccinesi
authors.affiliation: University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.
authors.forename: Alenka
authors.initials: A
authors.lastname: Mimić
authors.affiliation: Clinical and Descriptive Epidemiology Unit, ISPO Cancer Prevention and Research Institute, Florence, Italy.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Paci
authors.affiliation: International Observatory on the End-of-Life Care, Lancaster University, Lancaster, LA1 4YG, UK.
authors.forename: Sheila
authors.initials: S
authors.lastname: Payne
authors.affiliation: Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Polinder
authors.affiliation: School of Health Sciences, Sue Ryder Centre for the Study of Supportive, Palliative and End of Life Care, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
authors.forename: Kristian
authors.initials: K
authors.lastname: Pollock
authors.affiliation: School of Health Sciences, Sue Ryder Centre for the Study of Supportive, Palliative and End of Life Care, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Seymour
authors.affiliation: University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.
authors.forename: Anja
authors.initials: A
authors.lastname: Simonič
authors.affiliation: The Research Unit, Department of Palliative Medicine, Bispebjerg / Frederiksberg Hospital, Bispebjerg Bakke 23, 2400, København, NV, Denmark.|Department of Psychology, University of Southern Denmark, Campusvej 55, Odense, 5230, Denmark.
authors.forename: Anna Thit
authors.initials: AT
authors.lastname: Johnsen
authors.affiliation: End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.
authors.forename: Mariëtte N
authors.initials: MN
authors.lastname: Verkissen
authors.affiliation: Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Esther
authors.initials: E
authors.lastname: de Vries
authors.affiliation: School of Medicine, University of Nottingham, Nottingham University Hospitals NHS Trust, Nottingham, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Wilcock
authors.affiliation: Julius Center for Health Sciences and Primary Care, Medical School of Utrecht University, Utrecht, The Netherlands.
authors.forename: Marieke
authors.initials: M
authors.lastname: Zwakman
authors.affiliation: Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Agnes
authors.initials: A
authors.lastname: van der Heide Pl
mesh_terms: D000328:Adult; D032722:Advance Care Planning; D000368:Aged; D000369:Aged, 80 and over; D015179:Colorectal Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000628:therapy*; D003142:Communication; D003657:Decision Making; D005260:Female; D006282:Health Personnel; D006801:Humans; D008175:Lung Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D018802:Patient-Centered Care; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013727:Terminal Care
keywords: Advance care planning; Medical decision-making; Oncology; Quality of life