Towards optimal use of antithrombotic therapy of people with cancer at the end of life: A research protocol for the development and implementation of the SERENITY shared decision support tool.


Journal

Thrombosis research
ISSN: 1879-2472
Titre abrégé: Thromb Res
Pays: United States
ID NLM: 0326377

Informations de publication

Date de publication:
08 2023
Historique:
received: 09 03 2023
revised: 02 05 2023
accepted: 05 05 2023
medline: 3 7 2023
pubmed: 5 6 2023
entrez: 5 6 2023
Statut: ppublish

Résumé

Even though antithrombotic therapy has probably little or even negative effects on the well-being of people with cancer during their last year of life, deprescribing antithrombotic therapy at the end of life is rare in practice. It is often continued until death, possibly resulting in excess bleeding, an increased disease burden and higher healthcare costs. The SERENITY consortium comprises researchers and clinicians from eight European countries with specialties in different clinical fields, epidemiology and psychology. SERENITY will use a comprehensive approach combining a realist review, flash mob research, epidemiological studies, and qualitative interviews. The results of these studies will be used in a Delphi process to reach a consensus on the optimal design of the shared decision support tool. Next, the shared decision support tool will be tested in a randomised controlled trial. A targeted implementation and dissemination plan will be developed to enable the use of the SERENITY tool across Europe, as well as its incorporation in clinical guidelines and policies. The entire project is funded by Horizon Europe. SERENITY will develop an information-driven shared decision support tool that will facilitate treatment decisions regarding the appropriate use of antithrombotic therapy in people with cancer at the end of life. We aim to develop an intervention that guides the appropriate use of antithrombotic therapy, prevents bleeding complications, and saves healthcare costs. Hopefully, usage of the tool leads to enhanced empowerment and improved quality of life and treatment satisfaction of people with advanced cancer and their care givers.

Sections du résumé

BACKGROUND
Even though antithrombotic therapy has probably little or even negative effects on the well-being of people with cancer during their last year of life, deprescribing antithrombotic therapy at the end of life is rare in practice. It is often continued until death, possibly resulting in excess bleeding, an increased disease burden and higher healthcare costs.
METHODS
The SERENITY consortium comprises researchers and clinicians from eight European countries with specialties in different clinical fields, epidemiology and psychology. SERENITY will use a comprehensive approach combining a realist review, flash mob research, epidemiological studies, and qualitative interviews. The results of these studies will be used in a Delphi process to reach a consensus on the optimal design of the shared decision support tool. Next, the shared decision support tool will be tested in a randomised controlled trial. A targeted implementation and dissemination plan will be developed to enable the use of the SERENITY tool across Europe, as well as its incorporation in clinical guidelines and policies. The entire project is funded by Horizon Europe.
RESULTS
SERENITY will develop an information-driven shared decision support tool that will facilitate treatment decisions regarding the appropriate use of antithrombotic therapy in people with cancer at the end of life.
CONCLUSIONS
We aim to develop an intervention that guides the appropriate use of antithrombotic therapy, prevents bleeding complications, and saves healthcare costs. Hopefully, usage of the tool leads to enhanced empowerment and improved quality of life and treatment satisfaction of people with advanced cancer and their care givers.

Identifiants

pubmed: 37276718
pii: S0049-3848(23)00134-2
doi: 10.1016/j.thromres.2023.05.008
pii:
doi:

Substances chimiques

Fibrinolytic Agents 0

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

54-60

Subventions

Organisme : Marie Curie
ID : MCCC-FCO-11-C
Pays : United Kingdom

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest AAH reports grants, speaking, or consulting fees from Bayer, MSD, LEO-Pharma and Bristol-Myers Squibb/Pfizer. MS reports grants and consulting fees from Bayer. JJB is a speaker for Abbott and Edwards Lifesciences. GJG is vice-chair of the Dutch Federation of Thrombosis services, and reports grants from Bayer, BMS, Pfizer and Daiichi-Sankyo, The Dutch Research Council, The Netherlands Organisation for Health Research and Development, and the Dutch Heart Foundation, all unrelated to this work and paid to his institution. MVH reports grants from Dutch Heart Foundation, ZonMw, Bayer Health Care, Pfizer-BMS, and Leo Pharma, all unrelated to this work. FAK reports grants or contracts from Bayer, BMS, BSCI, MSD, Leo Pharma, Actelion, Varm-X, The Netherlands Organisation for Health Research and Development, the Dutch Thrombosis Association, The Dutch Heart Foundation and the Horizon Europe Program, all unrelated to this work and paid to his institution. AM reports advisory board honoraria from Bayer, BMS Sanofi and Pfizer, speaker's bureau for BMS and Bayer and an educational grant from Bayer. DM reports contracts from BMS, Leo Pharma, Pfizer and Sanofi. MJHAK reports grants from Sobi, The Netherlands Organisation for Health Research and Development and the Dutch Thrombosis Association and speakers fee from Roche, Sobi and BMS, all unrelated to this work and paid to his institution. FEMM reports grants from Yorkshire Cancer Research, Marie Curie Cancer Care, the UK National Institute of Health and Care Research, and Hull Clinical Commissioning Group, all unrelated to this work. LV reports a grant from the Dutch Cancer Society, the Netherlands Organization for Health Service Research and Development, and the Dutch Research Council, all unrelated to this work. All others report no conflicts of interest related to this project.

Auteurs

J Goedegebuur (J)

Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.

D Abbel (D)

Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands; Department of Medicine - Internal Medicine and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.

S Accassat (S)

Department of Vascular and Therapeutical Medicine, University Hospital of Saint-Etienne, Saint-Étienne, France.

W P Achterberg (WP)

Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.

A Akbari (A)

Swansea University, Swansea, Wales, United Kingdom.

V M Arfuch (VM)

Department of Medical Oncology, Hospital Clinic Barcelona, Clinical Institute of Haematological and Oncological Diseases (ICMHO), IDIBAPS, Barcelona, Spain.

E Baddeley (E)

Cardiff University, Cardiff, United Kingdom.

J J Bax (JJ)

Department of Medicine - Cardiology, Leiden University Medical Center, Leiden, the Netherlands.

D Becker (D)

University Medical Center Mainz, Mainz, Germany.

B Bergmeijer (B)

Todaytomorrow, Rotterdam, the Netherlands.

L Bertoletti (L)

Department of Vascular and Therapeutical Medicine, Jean Monnet University, University Hospital of Saint-Étienne, Saint-Étienne, France.

J W Blom (JW)

Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.

A Calvetti (A)

Assistance Publique-Hopitaux de Paris, Paris, France.

S C Cannegieter (SC)

Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.

L Castro (L)

Vall d'Hebron Research Institute, Barcelona, Spain.

N H Chavannes (NH)

Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.

N Coma-Auli (N)

Department of Medical Oncology, Hospital Clinic Barcelona, Clinical Institute of Haematological and Oncological Diseases (ICMHO), IDIBAPS, Barcelona, Spain.

C Couffignal (C)

Hôpital Louis Mourier, APHP, Assistance Publique-Hopitaux de Paris, Paris, France.

A Edwards (A)

Cardiff University, Cardiff, United Kingdom.

M Edwards (M)

Cardiff University, Cardiff, United Kingdom.

H Enggaard (H)

Aalborg University Hospital, Aalborg, Denmark.

C Font (C)

Department of Medical Oncology, Hospital Clinic Barcelona, Clinical Institute of Haematological and Oncological Diseases (ICMHO), IDIBAPS, Barcelona, Spain.

A Gava (A)

Societa per l'Assistenza al Malato Oncologico Terminale Onlus (S.A.M.O.T.) Ragusa Onlus, Ragusa, Italy.

G J Geersing (GJ)

Julius Center for Health Sciences and Primary Care, Department of General Practice, University Medical Center Utrecht, Utrecht, the Netherlands.

E C T Geijteman (ECT)

Department of Medical Oncology, Erasmus Medical Center, Rotterdam, the Netherlands.

S Greenley (S)

Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, United Kingdom.

C Gregory (C)

Cardiff University, Cardiff, United Kingdom.

J Gussekloo (J)

Department of Medicine - Internal Medicine and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands; Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.

I Hoffmann (I)

Hôpital Bichat, APHP, Assistance Publique-Hopitaux de Paris, Paris, France.

A A Højen (AA)

Aalborg University Hospital, Aalborg, Denmark.

W B van den Hout (WB)

Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.

M V Huisman (MV)

Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.

S Jacobsen (S)

Aalborg University Hospital, Aalborg, Denmark.

J Jagosh (J)

Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, United Kingdom.

M J Johnson (MJ)

Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, United Kingdom.

L Jørgensen (L)

Aalborg University Hospital, Aalborg, Denmark.

C C M Juffermans (CCM)

Centre of Expertise in Palliative Care, Leiden University Medical Center, Leiden, the Netherlands.

E K Kempers (EK)

Department of Hematology, Erasmus MC, Erasmus University Medical Center, Rotterdam, the Netherlands.

S Konstantinides (S)

University Medical Center Mainz, Mainz, Germany.

A F Kroder (AF)

Todaytomorrow, Rotterdam, the Netherlands.

M J H A Kruip (MJHA)

Department of Hematology, Erasmus MC, Erasmus University Medical Center, Rotterdam, the Netherlands.

L Lafaie (L)

Department of Geriatrics and Gerontology, Jean Monnet University, University Hospital of Saint-Étienne, Saint-Étienne, France.

J W Langendoen (JW)

Todaytomorrow, Rotterdam, the Netherlands.

T B Larsen (TB)

Aalborg University Hospital, Aalborg, Denmark.

K Lifford (K)

Cardiff University, Cardiff, United Kingdom.

Y M van der Linden (YM)

Centre of Expertise in Palliative Care, Leiden University Medical Center, Leiden, the Netherlands; Netherlands Comprehensive Cancer Organization, Utrecht, the Netherlands.

I Mahé (I)

Department of Innovative Therapies in Haemostasis, Hôpital Louis Mourier, APHP, Paris, France.

L Maiorana (L)

Societa per l'Assistenza al Malato Oncologico Terminale Onlus (S.A.M.O.T.) Ragusa Onlus, Ragusa, Italy.

A Maraveyas (A)

Clinical Sciences Centre Hull York Medical School University of Hull, Hull, United Kingdom.

E S L Martens (ESL)

Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.

D Mayeur (D)

Centre Georges-François Leclerc, Dijon, France.

T E van Mens (TE)

Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.

K Mohr (K)

University Medical Center Mainz, Mainz, Germany.

S P Mooijaart (SP)

Department of Medicine - Internal Medicine and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.

F E M Murtagh (FEM)

Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, United Kingdom.

A Nelson (A)

Cardiff University, Cardiff, United Kingdom.

P B Nielsen (PB)

Aalborg University Hospital, Aalborg, Denmark.

A G Ording (AG)

Aalborg University Hospital, Aalborg, Denmark.

M Ørskov (M)

Aalborg University Hospital, Aalborg, Denmark.

M Pearson (M)

Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, United Kingdom.

G Poenou (G)

Department of Vascular and Therapeutical Medicine, Jean Monnet University, University Hospital of Saint-Étienne, Saint-Étienne, France.

J E A Portielje (JEA)

Department of Medicine - Internal medicine and Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands.

D Raczkiewicz (D)

Department of Medical Statistics, School of Public Health, Centre of Postgraduate Medical Education, Warsaw, Poland.

K Rasmussen (K)

Aalborg University Hospital, Aalborg, Denmark.

E Trinks-Roerdink (E)

Julius Center for Health Sciences and Primary Care, Department of General Practice, University Medical Center Utrecht, Utrecht, the Netherlands.

I Schippers (I)

Todaytomorrow, Rotterdam, the Netherlands.

K Seddon (K)

Wales Cancer Research Centre, Cardiff, UK.

K Sexton (K)

Cardiff University, Cardiff, United Kingdom.

S Sivell (S)

Cardiff University, Cardiff, United Kingdom.

F Skjøth (F)

Aalborg University Hospital, Aalborg, Denmark.

M Søgaard (M)

Aalborg University Hospital, Aalborg, Denmark.

S Szmit (S)

Department of Cardio-Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland.

S Trompet (S)

Department of Medicine - Internal Medicine and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.

P Vassal (P)

Department of Vascular and Therapeutical Medicine, University Hospital of Saint-Etienne, Saint-Étienne, France.

C Visser (C)

Department of Hematology, Erasmus MC, Erasmus University Medical Center, Rotterdam, the Netherlands.

L M van Vliet (LM)

Department of Health, Medicine and Neuropsychology, Leiden University, Leiden, the Netherlands.

E Wilson (E)

Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, United Kingdom.

F A Klok (FA)

Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: F.A.Klok@lumc.nl.

S I R Noble (SIR)

Cardiff University, Cardiff, United Kingdom.

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