Towards Cancer Patient Empowerment for Optimal Use of Antithrombotic Therapy at the End of Life
- Conditions
- Terminal Cancer
- Registration Number
- NCT05706740
- Lead Sponsor
- Johannes Gutenberg University Mainz
- Brief Summary
Despite the fact that antithrombotic therapy (ATT) has little or even negative effects on the well-being of cancer patients during their last year of life, stopping ATT is rare in clinical practice. In contrast, antithrombotic therapy is often continued until death, resulting in excess bleeding, higher healthcare costs, and increased disease burden. SERENITY aims to develop an information-driven, palliative care shared decision-making process enabled by a user-friendly, easily accessible, web-based shared-decision support tool (SDST) that will facilitate treatment decisions regarding appropriate use of antithrombotic therapy in cancer patients at the end of life. SERENITY will use a comprehensive approach consisting of a combination of realist review, flash mob research, qualitative interviews, epidemiologic studies, and a randomized controlled trial.
The sub-project described here uses the flashmob research approach to address healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients.The survey will be conducted with approx. 800 physicians from eight European countries, all represented in the SERENITY consortium.
- Detailed Description
Deprescribing is an important part of palliative care to prevent polypharmacy, which is associated with increased risk of adverse drug events, drug-drug and drug-disease interactions, reduced functional capacity, multiple geriatric syndromes, medication nonadherence, and higher healthcare costs. One of the most widely used cardiovascular drug classes in cancer patients in a palliative setting are antithrombotics, including anticoagulant and anti-platelet substances. Antithrombotic drugs, e.g., direct oral anticoagulants (DOACs), low-molecular-weight heparins (LMWH), vitamin-K antagonists (VKA) and so-called antiplatelet agents (such as acetyl salicylic acid and P2Y12 inhibitors), are indicated in patients with prosthetic heart valves, in those with venous thromboembolism (VTE) or pulmonary embolism (PE), for stroke prevention in atrial fibrillation as well as in patients with established atherosclerotic cardiovascular disease (such as myocardial infarction, stroke, or peripheral artery disease). Most patients have been receiving these drugs chronically before their cancer was diagnosed, while others are prescribed them in order to treat or prevent cancer-associated thrombosis. Obviously, decisions on deprescribing antithrombotics heavily depend on the indication of the antithrombotic drug in addition to patient and healthcare professional preferences and experience, and on the estimated life expectancy of the patient.
Understanding current patterns of management of antithrombotic therapy as well as the rationale and preferences behind these patterns is crucial for improving clinical practice. Since deprescribing patterns and rationale may largely differ across the European Union, relevant data at a large scale is needed to fully understand and appreciate the relevant decision processes.
The insights gained in this study are a first step towards the development of a clinical decision tool supporting decisions on antithrombotic therapy in cancer patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 467
Healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients
N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relevance of patient's performance status (Eastern Cooperative Oncology Group 7 days (ECOG)) for the decision on continuation or discontinuation of antithrombotic therapy
Relevance of patient's bleeding risk for the decision on continuation or discontinuation of antithrombotic therapy 7 days Relevance of patient's preference (pro/contra continuation) for the decision on continuation or discontinuation of antithrombotic therapy 7 days Relevance of patient's prognosis for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care 7 days Relevance of patient's type of antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy 7 days Relevance of patient's thrombotic risk for the decision on continuation or discontinuation of antithrombotic therapy 7 days Relevance of patient's medication burden for the decision on continuation or discontinuation of antithrombotic therapy 7 days Current practice patterns across Europe with regard to the use of antithrombotic treatment in end-of-life care of cancer patients 7 days The main analysis of the FMR will be descriptive. Responses to the Discrete Choice Experiments will be used to generate preference coefficients for each level (e.g., high/low) of each attribute (e.g., bleeding risk)
Relevance of patient's indication for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy 7 days Relevance of patient's age for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care 7 days Relevance of patient's symptom burden for the decision on continuation or discontinuation of antithrombotic therapy 7 days Relevance of physician's experience (with deprescribing) for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy 7 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Assistance Publique - Hôpitaux de Paris
🇫🇷Paris, France
Centre Hospitalier Universitaire Saint Etienne
🇫🇷Saint-Étienne, France
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz
🇩🇪Mainz, Germany
Società Per L'Assistenza Al Malato Oncologico Terminale Onlus
🇮🇹Ragusa, Italy
Academisch Ziekenhuis Leiden (Lumc)
🇳🇱Leiden, Netherlands
Erasmus Universitair Medisch Centrum Rotterdam
🇳🇱Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
Centrum Medyczne Ksztalcenia Podyplomowego
🇵🇱Warsaw, Poland
Fundació ClÃnic Per A La Recerca Biomèdica
🇪🇸Barcelona, Spain
Cardiff University
🇬🇧Cardiff, United Kingdom
University of Hull
🇬🇧Hull, United Kingdom