Background: Awareness of preferences regarding medical care should be a central component of the care of\npatients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable\nmanner. Advance care planning (ACP) is a formalized process of communication between patients, relatives and\nprofessional caregivers about patients� values and care preferences. It raises awareness of the need to anticipate\npossible future deterioration of health. ACP has the potential to improve current and future healthcare decisionmaking,\nprovide patients with a sense of control, and improve their quality of life.\nMethods/Design: We will study the effects of the ACP program Respecting Choices on the quality of life of\npatients with advanced lung or colorectal cancer. In a phase III multicenter cluster randomised controlled trial, 22\nhospitals in 6 countries will be randomised. In the intervention sites, patients will be offered interviews with a\ntrained facilitator. In the control sites, patients will receive care as usual. In total, 1360 patients will be included. All\nparticipating patients will be asked to complete questionnaires at inclusion, and again after 2.5 and 4.5 months. If a\npatient dies within a year after inclusion, a relative will be asked to complete a questionnaire on end-of-life care.\nUse of medical care will be assessed by checking medical files. The primary endpoint is patients� quality of life at\n2.5 months post-inclusion. Secondary endpoints are the extent to which care as received is aligned with patients�\npreferences, patients� evaluation of decision-making processes, quality of end-of-life care and cost-effectiveness of\nthe intervention. A complementary qualitative study will be carried out to explore the lived experience of\nengagement with the Respecting Choices program from the perspectives of patients, their Personal\nRepresentatives, healthcare providers and facilitators.\nDiscussion: Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on\naverage are younger and retain their mental capacity for a larger part of their disease trajectory, is an important\nnext step in an era of increased focus on patient centered healthcare and shared decision-making.\n(Continued on next page)
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