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Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol
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| Zeitschriftentitel: | BMJ Open |
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| Personen und Körperschaften: | , , , , , , , , , , , , , , , , , , , , , , |
| In: | BMJ Open, 10, 2020, 1, S. e034378 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
BMJ
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| Schlagwörter: |
| author_facet |
Golla, Heidrun Nettekoven, Charlotte Bausewein, Claudia Tonn, Jörg-Christian Thon, Niklas Feddersen, Berend Schnell, Oliver Böhlke, Christopher Becker, Gerhild Rolke, Roman Clusmann, Hans Herrlinger, Ulrich Radbruch, Lukas Vatter, Hartmut Güresir, Erdem Stock, Stephanie Müller, Dirk Civello, Daniele Papachristou, Irini Hellmich, Martin Hamacher, Stefanie Voltz, Raymond Goldbrunner, Roland Golla, Heidrun Nettekoven, Charlotte Bausewein, Claudia Tonn, Jörg-Christian Thon, Niklas Feddersen, Berend Schnell, Oliver Böhlke, Christopher Becker, Gerhild Rolke, Roman Clusmann, Hans Herrlinger, Ulrich Radbruch, Lukas Vatter, Hartmut Güresir, Erdem Stock, Stephanie Müller, Dirk Civello, Daniele Papachristou, Irini Hellmich, Martin Hamacher, Stefanie Voltz, Raymond Goldbrunner, Roland |
|---|---|
| author |
Golla, Heidrun Nettekoven, Charlotte Bausewein, Claudia Tonn, Jörg-Christian Thon, Niklas Feddersen, Berend Schnell, Oliver Böhlke, Christopher Becker, Gerhild Rolke, Roman Clusmann, Hans Herrlinger, Ulrich Radbruch, Lukas Vatter, Hartmut Güresir, Erdem Stock, Stephanie Müller, Dirk Civello, Daniele Papachristou, Irini Hellmich, Martin Hamacher, Stefanie Voltz, Raymond Goldbrunner, Roland |
| spellingShingle |
Golla, Heidrun Nettekoven, Charlotte Bausewein, Claudia Tonn, Jörg-Christian Thon, Niklas Feddersen, Berend Schnell, Oliver Böhlke, Christopher Becker, Gerhild Rolke, Roman Clusmann, Hans Herrlinger, Ulrich Radbruch, Lukas Vatter, Hartmut Güresir, Erdem Stock, Stephanie Müller, Dirk Civello, Daniele Papachristou, Irini Hellmich, Martin Hamacher, Stefanie Voltz, Raymond Goldbrunner, Roland BMJ Open Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol General Medicine |
| author_sort |
golla, heidrun |
| spelling |
Golla, Heidrun Nettekoven, Charlotte Bausewein, Claudia Tonn, Jörg-Christian Thon, Niklas Feddersen, Berend Schnell, Oliver Böhlke, Christopher Becker, Gerhild Rolke, Roman Clusmann, Hans Herrlinger, Ulrich Radbruch, Lukas Vatter, Hartmut Güresir, Erdem Stock, Stephanie Müller, Dirk Civello, Daniele Papachristou, Irini Hellmich, Martin Hamacher, Stefanie Voltz, Raymond Goldbrunner, Roland 2044-6055 2044-6055 BMJ General Medicine http://dx.doi.org/10.1136/bmjopen-2019-034378 <jats:sec><jats:title>Introduction</jats:title><jats:p>Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients’ quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life. However, RCTs investigating the positive effect of EIPC for patients suffering from glioblastoma multiforme (GBM) are lacking. After modelling work identifying the specific needs of GBM patients and their caregivers, the aim of this study is to investigate the impact of EIPC in this particular patient group.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>The recruitment period of this multicenter RCT started in May 2019. GBM patients (n=214) and their caregivers will be randomly assigned to either the intervention group (receiving proactive EIPC on a monthly basis) or the control group (receiving treatment according to international standards and additional, regular assessment of QoL (‘optimised’ standard care)).</jats:p><jats:p>The primary outcome is QoL assessed by subscales of the Functional Assessment of Cancer Therapy for brain tumour (FACT-Br) from baseline to 6 months of treatment. Secondary outcomes are changes in QoL after 12 (end of intervention), 18 and 24 months (end of follow-up), the full FACT-Br scale, patients’ palliative care needs, depression/anxiety, cognitive impairment, caregiver burden, healthcare use, cost-effectiveness and overall survival.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the local ethics committees of the University Clinics of Cologne, Aachen, Bonn, Freiburg and Munich (LMU). Results of the trial will be submitted for publication in a peer-reviewed, open access journal and disseminated through presentations at conferences.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>German Register for Clinical Studies (DRKS) (DRKS00016066); Pre-results.</jats:p></jats:sec> Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol BMJ Open |
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| title |
Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
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Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
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Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
| title_fullStr |
Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
| title_full_unstemmed |
Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
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Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
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effect of early palliative care for patients with glioblastoma (epcog): a randomised phase iii clinical trial protocol |
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General Medicine |
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<jats:sec><jats:title>Introduction</jats:title><jats:p>Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients’ quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life. However, RCTs investigating the positive effect of EIPC for patients suffering from glioblastoma multiforme (GBM) are lacking. After modelling work identifying the specific needs of GBM patients and their caregivers, the aim of this study is to investigate the impact of EIPC in this particular patient group.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>The recruitment period of this multicenter RCT started in May 2019. GBM patients (n=214) and their caregivers will be randomly assigned to either the intervention group (receiving proactive EIPC on a monthly basis) or the control group (receiving treatment according to international standards and additional, regular assessment of QoL (‘optimised’ standard care)).</jats:p><jats:p>The primary outcome is QoL assessed by subscales of the Functional Assessment of Cancer Therapy for brain tumour (FACT-Br) from baseline to 6 months of treatment. Secondary outcomes are changes in QoL after 12 (end of intervention), 18 and 24 months (end of follow-up), the full FACT-Br scale, patients’ palliative care needs, depression/anxiety, cognitive impairment, caregiver burden, healthcare use, cost-effectiveness and overall survival.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the local ethics committees of the University Clinics of Cologne, Aachen, Bonn, Freiburg and Munich (LMU). Results of the trial will be submitted for publication in a peer-reviewed, open access journal and disseminated through presentations at conferences.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>German Register for Clinical Studies (DRKS) (DRKS00016066); Pre-results.</jats:p></jats:sec> |
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| description | <jats:sec><jats:title>Introduction</jats:title><jats:p>Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients’ quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life. However, RCTs investigating the positive effect of EIPC for patients suffering from glioblastoma multiforme (GBM) are lacking. After modelling work identifying the specific needs of GBM patients and their caregivers, the aim of this study is to investigate the impact of EIPC in this particular patient group.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>The recruitment period of this multicenter RCT started in May 2019. GBM patients (n=214) and their caregivers will be randomly assigned to either the intervention group (receiving proactive EIPC on a monthly basis) or the control group (receiving treatment according to international standards and additional, regular assessment of QoL (‘optimised’ standard care)).</jats:p><jats:p>The primary outcome is QoL assessed by subscales of the Functional Assessment of Cancer Therapy for brain tumour (FACT-Br) from baseline to 6 months of treatment. Secondary outcomes are changes in QoL after 12 (end of intervention), 18 and 24 months (end of follow-up), the full FACT-Br scale, patients’ palliative care needs, depression/anxiety, cognitive impairment, caregiver burden, healthcare use, cost-effectiveness and overall survival.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the local ethics committees of the University Clinics of Cologne, Aachen, Bonn, Freiburg and Munich (LMU). Results of the trial will be submitted for publication in a peer-reviewed, open access journal and disseminated through presentations at conferences.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>German Register for Clinical Studies (DRKS) (DRKS00016066); Pre-results.</jats:p></jats:sec> |
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| spelling | Golla, Heidrun Nettekoven, Charlotte Bausewein, Claudia Tonn, Jörg-Christian Thon, Niklas Feddersen, Berend Schnell, Oliver Böhlke, Christopher Becker, Gerhild Rolke, Roman Clusmann, Hans Herrlinger, Ulrich Radbruch, Lukas Vatter, Hartmut Güresir, Erdem Stock, Stephanie Müller, Dirk Civello, Daniele Papachristou, Irini Hellmich, Martin Hamacher, Stefanie Voltz, Raymond Goldbrunner, Roland 2044-6055 2044-6055 BMJ General Medicine http://dx.doi.org/10.1136/bmjopen-2019-034378 <jats:sec><jats:title>Introduction</jats:title><jats:p>Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients’ quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life. However, RCTs investigating the positive effect of EIPC for patients suffering from glioblastoma multiforme (GBM) are lacking. After modelling work identifying the specific needs of GBM patients and their caregivers, the aim of this study is to investigate the impact of EIPC in this particular patient group.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>The recruitment period of this multicenter RCT started in May 2019. GBM patients (n=214) and their caregivers will be randomly assigned to either the intervention group (receiving proactive EIPC on a monthly basis) or the control group (receiving treatment according to international standards and additional, regular assessment of QoL (‘optimised’ standard care)).</jats:p><jats:p>The primary outcome is QoL assessed by subscales of the Functional Assessment of Cancer Therapy for brain tumour (FACT-Br) from baseline to 6 months of treatment. Secondary outcomes are changes in QoL after 12 (end of intervention), 18 and 24 months (end of follow-up), the full FACT-Br scale, patients’ palliative care needs, depression/anxiety, cognitive impairment, caregiver burden, healthcare use, cost-effectiveness and overall survival.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the local ethics committees of the University Clinics of Cologne, Aachen, Bonn, Freiburg and Munich (LMU). Results of the trial will be submitted for publication in a peer-reviewed, open access journal and disseminated through presentations at conferences.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>German Register for Clinical Studies (DRKS) (DRKS00016066); Pre-results.</jats:p></jats:sec> Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol BMJ Open |
| spellingShingle | Golla, Heidrun, Nettekoven, Charlotte, Bausewein, Claudia, Tonn, Jörg-Christian, Thon, Niklas, Feddersen, Berend, Schnell, Oliver, Böhlke, Christopher, Becker, Gerhild, Rolke, Roman, Clusmann, Hans, Herrlinger, Ulrich, Radbruch, Lukas, Vatter, Hartmut, Güresir, Erdem, Stock, Stephanie, Müller, Dirk, Civello, Daniele, Papachristou, Irini, Hellmich, Martin, Hamacher, Stefanie, Voltz, Raymond, Goldbrunner, Roland, BMJ Open, Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol, General Medicine |
| title | Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
| title_full | Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
| title_fullStr | Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
| title_full_unstemmed | Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
| title_short | Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
| title_sort | effect of early palliative care for patients with glioblastoma (epcog): a randomised phase iii clinical trial protocol |
| title_unstemmed | Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol |
| topic | General Medicine |
| url | http://dx.doi.org/10.1136/bmjopen-2019-034378 |