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

(2016) BMC CANCER. 16.
Author
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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.
Keywords
IMPLEMENTATION, END, INTERVENTION, ASSOCIATION, DEPRESSION, ANXIETY, SCALE, QUALITY-OF-LIFE, CANCER-PATIENTS, Quality of life, Medical decision-making, Advance care planning, Oncology

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Citation

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Chicago
Rietjens, Judith AC, Ida J Korfage, Lesley Dunleavy, Nancy J Preston, Lea J Jabbarian, Caroline Arnfeldt Christensen, Maja de Brito, et al. 2016. “Advance Care Planning - a Multi-centre Cluster Randomised Clinical Trial: The Research Protocol of the ACTION Study.” Bmc Cancer 16.
APA
Rietjens, J. A., Korfage, I. J., Dunleavy, L., Preston, N. J., Jabbarian, L. J., Christensen, C. A., de Brito, M., et al. (2016). Advance care planning - a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study. BMC CANCER, 16.
Vancouver
1.
Rietjens JA, Korfage IJ, Dunleavy L, Preston NJ, Jabbarian LJ, Christensen CA, et al. Advance care planning - a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study. BMC CANCER. 2016;16.
MLA
Rietjens, Judith AC, Ida J Korfage, Lesley Dunleavy, et al. “Advance Care Planning - a Multi-centre Cluster Randomised Clinical Trial: The Research Protocol of the ACTION Study.” BMC CANCER 16 (2016): n. pag. Print.
@article{7207881,
  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.},
  articleno    = {264},
  author       = {Rietjens, Judith AC and Korfage, Ida J and Dunleavy, Lesley and Preston, Nancy J and Jabbarian, Lea J and Christensen, Caroline Arnfeldt and de Brito, Maja and Bulli, Francesco and Caswell, Glenys and \v{C}erv, Branka and van Delden, Johannes and Deliens, Luc and Gorini, Giuseppe and Groenvold, Mogens and Houttekier, Dirk and Ingravallo, Francesca and Kars, Marijke C and Lunder, Ur\v{s}ka and Miccinesi, Guido and Mimi\'{c}, Alenka and Paci, Eugenio and Payne, Sheila and Polinder, Suzanne and Pollock, Kristian and Seymour, Jane and Simoni\v{c}, Anja and Johnsen, Anna Thit and Verkissen, Mari{\"e}tte N and de Vries, Esther and Wilcock, Andrew and Zwakman, Marieke and van der Heide, Agnes},
  issn         = {1471-2407},
  journal      = {BMC CANCER},
  keyword      = {IMPLEMENTATION,END,INTERVENTION,ASSOCIATION,DEPRESSION,ANXIETY,SCALE,QUALITY-OF-LIFE,CANCER-PATIENTS,Quality of life,Medical decision-making,Advance care planning,Oncology},
  language     = {eng},
  pages        = {8},
  title        = {Advance care planning - a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study},
  url          = {http://dx.doi.org/10.1186/s12885-016-2298-x},
  volume       = {16},
  year         = {2016},
}

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