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Advance care planning, a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study

Rietjens, Judith A. C.; Korfage, Ida J.; Dunleavy, Lesley; Preston, Nancy J.; Jabbarian, Lea J.; Christensen, Caroline Arnfeldt; de Brito, Maja; Bulli, Francesco; Caswell, Glenys; ?erv, Branka; van Delden, Johannes; Deliens, Luc; Gorini, Giuseppe; Groenvold, Mogens; Houttekier, Dirk; Ingravallo, Francesca; Kars, Marijke C.; Lunder, Ur�ka; Miccinesi, Guido; Mimi?, Alenka; Paci, Eugenio; Payne, Sheila; Polinder, Suzanne; Pollock, Kristian; Seymour, Jane; Simoni?, Anja; Johnsen, Anna Thit; Verkissen, Mari�tte N.; de Vries, Esther; Wilcock, Andrew; Zwakman, Marieke; van der Heide, Agnes

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Judith A. C. Rietjens

Ida J. Korfage

Lesley Dunleavy

Nancy J. Preston

Lea J. Jabbarian

Caroline Arnfeldt Christensen

Maja de Brito

Francesco Bulli

Glenys Caswell

Branka ?erv

Johannes van Delden

Luc Deliens

Giuseppe Gorini

Mogens Groenvold

Dirk Houttekier

Francesca Ingravallo

Marijke C. Kars

Ur�ka Lunder

Guido Miccinesi

Alenka Mimi?

Eugenio Paci

Sheila Payne

Suzanne Polinder

Kristian Pollock

Jane Seymour

Anja Simoni?

Anna Thit Johnsen

Mari�tte N. Verkissen

Esther de Vries

Andrew Wilcock

Marieke Zwakman

Agnes van der Heide


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 ost-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.
Keywords: Advance care planning, Oncology, Quality of life, Medical decision-making

Journal Article Type Article
Acceptance Date Mar 30, 2016
Publication Date Apr 8, 2016
Deposit Date Jun 22, 2016
Publicly Available Date Jun 22, 2016
Journal BMC Cancer
Electronic ISSN 1471-2407
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 16
Issue 264
Keywords Advance care planning, Oncology, Quality of life, Medical decision-making
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