1. Advance care planning – a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study
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Lesley Dunleavy, Kristian Pollock, Agnes van der Heide, Francesca Ingravallo, Jane Seymour, Johannes J.M. van Delden, Mariëtte N. Verkissen, Glenys Caswell, Luc Deliens, Anja Simonič, Esther de Vries, Caroline Arnfeldt Christensen, Ida J. Korfage, Eugenio Paci, Mogens Groenvold, Marijke C. Kars, Nancy Preston, Lea J. Jabbarian, Urska Lunder, Giuseppe Gorini, Marieke Zwakman, Judith A.C. Rietjens, Dirk Houttekier, Guido Miccinesi, Maja de Brito, Andrew Wilcock, Alenka Mimić, Sheila Payne, Francesco Bulli, Suzanne Polinder, Branka Červ, Anna Thit Johnsen, Rietjens, Judith A.C, Korfage, Ida J., Dunleavy, Lesley, Preston, Nancy J., Jabbarian, Lea J., Christensen, Caroline Arnfeldt, de Brito, Maja, Bulli, Francesco, Caswell, Gleny, Červ, Branka, van Delden, Johanne, Deliens, Luc, Gorini, Giuseppe, Groenvold, Mogen, Houttekier, Dirk, Ingravallo, Francesca, Kars, Marijke C., Lunder, Urška, Miccinesi, Guido, Mimić, Alenka, Paci, Eugenio, Payne, Sheila, Polinder, Suzanne, Pollock, Kristian, Seymour, Jane, Simonič, Anja, Johnsen, Anna Thit, Verkissen, Mariëtte N., de Vries, Esther, Wilcock, Andrew, Zwakman, Marieke, van der Heide, Agnes, Family Medicine and Chronic Care, End-of-life Care Research Group, Faculty of Medicine and Pharmacy, and Public Health
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Male ,Advance care planning ,Cancer Research ,Lung Neoplasms ,Clinical Trial, Phase III ,Colorectal Neoplasm ,law.invention ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,Quality of life ,QUALITY-OF-LIFE ,law ,Surveys and Questionnaires ,Patient-Centered Care ,Health care ,Medicine and Health Sciences ,IMPLEMENTATION ,ANXIETY ,Surveys and Questionnaire ,030212 general & internal medicine ,Cluster randomised controlled trial ,Non-U.S. Gov't ,SCALE ,Aged, 80 and over ,Terminal Care ,Research Support, Non-U.S. Gov't ,Communication ,ASSOCIATION ,Middle Aged ,DEPRESSION ,Clinical Trial ,3. Good health ,Multicenter Study ,Oncology ,030220 oncology & carcinogenesis ,Randomized Controlled Trial ,END ,Female ,Colorectal Neoplasms ,INTERVENTION ,Human ,Adult ,medicine.medical_specialty ,Health Personnel ,Decision Making ,CANCER-PATIENTS ,Research Support ,03 medical and health sciences ,Phase III ,SDG 3 - Good Health and Well-being ,Journal Article ,Genetics ,medicine ,Humans ,Aged ,business.industry ,Medical decision-making ,Lung Neoplasm ,Clinical trial ,Action study ,Family medicine ,Facilitator ,Physical therapy ,business - 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.
- Published
- 2016
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