title: Advance care planning in patients with incurable cancer: study protocol for a randomised controlled trial.
abstract: There is limited evidence documenting the effectiveness of Advance Care Planning (ACP) in cancer care. The present randomised trial is designed to evaluate whether the administration of formal ACP improves compliance with patients' end-of-life (EOL) wishes and patient and family satisfaction with care.
  
  
  
  A randomised control trial in eight oncology centres across New South Wales and Victoria, Australia, is designed to assess the efficacy of a formal ACP intervention for patients with cancer. Patients with incurable cancer and an expected survival of 3-12 months, plus a nominated family member or friend will be randomised to receive either standard care or standard care plus a formal ACP intervention. The project sample size is 210 patient-family/friend dyads. The primary outcome measure is family/friend-reported: (1) discussion with the patient about their EOL wishes and (2) perception that the patient's EOL wishes were met. Secondary outcome measures include: documentation of and compliance with patient preferences for medical intervention at the EOL; the family/friend's perception of the quality of the patient's EOL care; the impact of death on surviving family; patient-family and patient-healthcare provider communication about EOL care; patient and family/friend satisfaction with care; quality of life of patient and family/friend subsequent to trial entry, the patient's strength of preferences for quality of life and length of life; the costs of care subsequent to trial entry and place of death.
  
  
  
  Ethical approval was received from the Sydney Local Health District (RPA Zone) Human Research Ethical Committee, Australia (Protocol number X13-0064). Study results will be submitted for publication in peer-reviewed journals and presented at national and international conferences.
  
  
  
  Pre-results; ACTRN12613001288718.
authors.affiliation: Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, University of Sydney, Sydney, New South Wales, Australia.|Department of Cancer Medicine, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Stephanie
authors.identifier: 0000-0002-6777-8816
authors.initials: S
authors.lastname: Johnson
authors.affiliation: HammondCare Palliative and Supportive Care Service, Greenwich Hospital, Sydney, New South Wales, Australia.|Kolling Institute of Medical Research, Northern Clinical School, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Josephine
authors.initials: J
authors.lastname: Clayton
authors.affiliation: Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Phyllis N
authors.initials: PN
authors.lastname: Butow
authors.affiliation: Advance Care Planning Department, Austin Hospital, Melbourne, Victoria, Australia.
authors.forename: William
authors.initials: W
authors.lastname: Silvester
authors.affiliation: Advance Care Planning Department, Austin Hospital, Melbourne, Victoria, Australia.
authors.forename: Karen
authors.initials: K
authors.lastname: Detering
authors.affiliation: Centre for Health Economics Research and Evaluation, University of Technology, Sydney, New South Wales, Australia.
authors.forename: Jane
authors.initials: J
authors.lastname: Hall
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Belinda E
authors.initials: BE
authors.lastname: Kiely
authors.affiliation: Ludwig Institute for Cancer Research, Melbourne, Victoria, Australia.
authors.forename: Jonathon
authors.initials: J
authors.lastname: Cebon
authors.affiliation: Kolling Institute of Medical Research, Northern Clinical School, University of Sydney, Sydney, New South Wales, Australia.|Department of Medical Oncology, Royal North Shore Hospital Sydney, Sydney, New South Wales, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Clarke
authors.affiliation: Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona, USA.
authors.forename: Melanie L
authors.initials: ML
authors.lastname: Bell
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Martin
authors.initials: M
authors.lastname: Stockler
authors.affiliation: Department of Medical Oncology, Sydney Local Health District (SLHD) and Royal Prince Alfred Hospital (RPA), Sydney, New South Wales, Australia.
authors.forename: Phillip
authors.initials: P
authors.lastname: Beale
authors.affiliation: Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, University of Sydney, Sydney, New South Wales, Australia.|Department of Cancer Medicine, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Martin H N
authors.initials: MH
authors.lastname: Tattersall
mesh_terms: D032722:Advance Care Planning / Q000191:economics; D003142:Communication; D003643:Death; D005190:Family / Q000523:psychology; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D010358:Patient Participation; D057240:Patient Preference; D057184:Practice Patterns, Nurses'; D011368:Professional-Family Relations; D011369:Professional-Patient Relations; D011787:Quality of Health Care; D011788:Quality of Life; D012107:Research Design; D013727:Terminal Care / Q000191:economics
keywords: Advance Directive; Advance care planning; End of Life; Randomised controlled trial