Advance care planning--a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study.
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.
['Rietjens|Judith A C|JA|', 'Korfage|Ida J|IJ|', 'Dunleavy|Lesley|L|', 'Preston|Nancy J|NJ|', 'Jabbarian|Lea J|LJ|', 'Christensen|Caroline Arnfeldt|CA|', 'de Brito|Maja|M|', 'Bulli|Francesco|F|', 'Caswell|Glenys|G|', 'Červ|Branka|B|', 'van Delden|Johannes|J|', 'Deliens|Luc|L|', 'Gorini|Giuseppe|G|', 'Groenvold|Mogens|M|', 'Houttekier|Dirk|D|', 'Ingravallo|Francesca|F|', 'Kars|Marijke C|MC|', 'Lunder|Urška|U|', 'Miccinesi|Guido|G|', 'Mimić|Alenka|A|', 'Paci|Eugenio|E|', 'Payne|Sheila|S|', 'Polinder|Suzanne|S|', 'Pollock|Kristian|K|', 'Seymour|Jane|J|', 'Simonič|Anja|A|', 'Johnsen|Anna Thit|AT|', 'Verkissen|Mariëtte N|MN|', 'de Vries|Esther|E|', 'Wilcock|Andrew|A|', 'Zwakman|Marieke|M|', 'van der Heide Pl|Agnes|A|']
D000328:Adult D032722:Advance Care Planning D000368:Aged D000369:Aged, 80 and over D015179:Colorectal Neoplasms D003142:Communication D003657:Decision Making D005260:Female D006282:Health Personnel D006801:Humans D008175:Lung Neoplasms D008297:Male D008875:Middle Aged D018802:Patient-Centered Care D011788:Quality of Life D011795:Surveys and Questionnaires D013727:Terminal Care
Advance care planning Quality of life Medical decision-making Oncology