Introduction 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.
Methods and analysis 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.
Ethics and dissemination 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.
Trial registration number Pre-results; ACTRN12613001288718.
- Advance care planning
- Advance Directive
- End of Life
- Randomised controlled trial
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Contributors SJ drafted the manuscript, and is the study coordinator with responsibility for coordinating development of the study materials and collection of data. MHNT developed the Research Application in collaboration with WS, KD, JCl, PNB and MLB. JCl, WS, KD, PNB and BEK refined the research methods and developed the Advanced Care Planning (ACP) intervention for patients with cancer. SC, PB and JCe provided clinical leadership in recruitment of patients and protocol development. MS and BK developed the segment of the ACP relating to estimating and communicating patient life expectancy. JH proposed the inclusion of healthcare cost estimates in the data collected, and the inclusion of the discrete choice experiment. All authors reviewed and approved the manuscript.
Funding This work was supported by the National Health and Medical Research Council grant number APP1050596.
Competing interests None declared.
Ethics approval Sydney Local Health District (RPA Zone) Human Research Ethical Committee, Australia (Protocol number X13-0064).
Provenance and peer review Not commissioned; externally peer reviewed.
Data Sharing Statement This is an Open Access article.
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