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Advance care planning--a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study.
BMC Cancer. 2016 Apr 08; 16:264.BC

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/DESIGN

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.

DISCUSSION

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.

TRIAL REGISTRATION

International Standard Randomised Controlled Trial Number: ISRCTN63110516. Date of registration: 10/3/2014.

Authors+Show Affiliations

Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands. j.rietjens@erasmusmc.nl.Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.International Observatory on the End-of-Life Care, Lancaster University, Lancaster, LA1 4YG, UK.International Observatory on the End-of-Life Care, Lancaster University, Lancaster, LA1 4YG, UK.Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014, København, Denmark.University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.Clinical and Descriptive Epidemiology Unit, ISPO Cancer Prevention and Research Institute, Florence, Italy.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.University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.Julius Center for Health Sciences and Primary Care, Medical School of Utrecht University, Utrecht, The Netherlands.End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium. Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium.Clinical and Descriptive Epidemiology Unit, ISPO Cancer Prevention and Research Institute, Florence, Italy.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.End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.Julius Center for Health Sciences and Primary Care, Medical School of Utrecht University, Utrecht, The Netherlands.University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.Clinical and Descriptive Epidemiology Unit, ISPO Cancer Prevention and Research Institute, Florence, Italy.University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.Clinical and Descriptive Epidemiology Unit, ISPO Cancer Prevention and Research Institute, Florence, Italy.International Observatory on the End-of-Life Care, Lancaster University, Lancaster, LA1 4YG, UK.Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.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.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.University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.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.End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.School of Medicine, University of Nottingham, Nottingham University Hospitals NHS Trust, Nottingham, UK.Julius Center for Health Sciences and Primary Care, Medical School of Utrecht University, Utrecht, The Netherlands.Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27059593

Citation

Rietjens, Judith A C., et al. "Advance Care Planning--a Multi-centre Cluster Randomised Clinical Trial: the Research Protocol of the ACTION Study." BMC Cancer, vol. 16, 2016, p. 264.
Rietjens JA, Korfage IJ, Dunleavy L, et al. Advance care planning--a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study. BMC Cancer. 2016;16:264.
Rietjens, J. A., Korfage, I. J., Dunleavy, L., Preston, N. J., Jabbarian, L. J., Christensen, C. A., de Brito, M., Bulli, F., Caswell, G., Červ, B., van Delden, J., Deliens, L., Gorini, G., Groenvold, M., Houttekier, D., Ingravallo, F., Kars, M. C., Lunder, U., Miccinesi, G., ... van der Heide Pl, A. (2016). Advance care planning--a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study. BMC Cancer, 16, 264. https://doi.org/10.1186/s12885-016-2298-x
Rietjens JA, et al. Advance Care Planning--a Multi-centre Cluster Randomised Clinical Trial: the Research Protocol of the ACTION Study. BMC Cancer. 2016 Apr 8;16:264. PubMed PMID: 27059593.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Advance care planning--a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study. AU - Rietjens,Judith A C, AU - Korfage,Ida J, AU - Dunleavy,Lesley, AU - Preston,Nancy J, AU - Jabbarian,Lea J, AU - Christensen,Caroline Arnfeldt, AU - de Brito,Maja, AU - Bulli,Francesco, AU - Caswell,Glenys, AU - Červ,Branka, AU - van Delden,Johannes, AU - Deliens,Luc, AU - Gorini,Giuseppe, AU - Groenvold,Mogens, AU - Houttekier,Dirk, AU - Ingravallo,Francesca, AU - Kars,Marijke C, AU - Lunder,Urška, AU - Miccinesi,Guido, AU - Mimić,Alenka, AU - Paci,Eugenio, AU - Payne,Sheila, AU - Polinder,Suzanne, AU - Pollock,Kristian, AU - Seymour,Jane, AU - Simonič,Anja, AU - Johnsen,Anna Thit, AU - Verkissen,Mariëtte N, AU - de Vries,Esther, AU - Wilcock,Andrew, AU - Zwakman,Marieke, AU - van der Heide Pl,Agnes, Y1 - 2016/04/08/ PY - 2015/09/04/received PY - 2016/03/30/accepted PY - 2016/4/10/entrez PY - 2016/4/10/pubmed PY - 2016/12/15/medline KW - Advance care planning KW - Medical decision-making KW - Oncology KW - Quality of life SP - 264 EP - 264 JF - BMC cancer JO - BMC Cancer VL - 16 N2 - 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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN63110516. Date of registration: 10/3/2014. SN - 1471-2407 UR - https://www.unboundmedicine.com/medline/citation/27059593/Advance_care_planning__a_multi_centre_cluster_randomised_clinical_trial:_the_research_protocol_of_the_ACTION_study_ L2 - https://bmccancer.biomedcentral.com/articles/10.1186/s12885-016-2298-x DB - PRIME DP - Unbound Medicine ER -