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 p...
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| Format: | Article |
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BioMed Central
2016
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| Online Access: | https://eprints.nottingham.ac.uk/34318/ |
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| author | 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 Červ, Branka van Delden, Johannes Deliens, Luc Gorini, Giuseppe Groenvold, Mogens 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 |
| author_facet | 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 Červ, Branka van Delden, Johannes Deliens, Luc Gorini, Giuseppe Groenvold, Mogens 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 |
| author_sort | Rietjens, Judith A. C. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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 |
| first_indexed | 2025-11-14T19:22:19Z |
| format | Article |
| id | nottingham-34318 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:22:19Z |
| publishDate | 2016 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-343182020-05-04T17:47:19Z https://eprints.nottingham.ac.uk/34318/ 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 Červ, Branka van Delden, Johannes Deliens, Luc Gorini, Giuseppe Groenvold, Mogens 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 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 BioMed Central 2016-04-08 Article PeerReviewed 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, Červ, Branka, van Delden, Johannes, Deliens, Luc, Gorini, Giuseppe, Groenvold, Mogens, 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 and van der Heide, Agnes (2016) Advance care planning, a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study. BMC Cancer, 16 (264). pp. 1-8. ISSN 1471-2407 Advance care planning Oncology Quality of life Medical decision-making http://bmccancer.biomedcentral.com/articles/10.1186/s12885-016-2298-x doi:10.1186/s12885-016-2298-x doi:10.1186/s12885-016-2298-x |
| spellingShingle | Advance care planning Oncology Quality of life Medical decision-making 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 Červ, Branka van Delden, Johannes Deliens, Luc Gorini, Giuseppe Groenvold, Mogens 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 Advance care planning, a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study |
| title | Advance care planning, a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study |
| title_full | Advance care planning, a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study |
| title_fullStr | Advance care planning, a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study |
| title_full_unstemmed | Advance care planning, a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study |
| title_short | Advance care planning, a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study |
| title_sort | advance care planning, a multi-centre cluster randomised clinical trial: the research protocol of the action study |
| topic | Advance care planning Oncology Quality of life Medical decision-making |
| url | https://eprints.nottingham.ac.uk/34318/ https://eprints.nottingham.ac.uk/34318/ https://eprints.nottingham.ac.uk/34318/ |