Clinical trial NCT05706740: Towards Cancer Patient Empowerment for Optimal Use of Antithrombotic Therapy at the End of Life
Official title: Understanding Patterns of Deprescribing Antithrombotic Medication During End-of-Life Care in Cancer Patients Across the European Union
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Terminal Cancer
Keywords: palliative care
antithrombotic therapy
deprescription
advanced cancer
thrombosis
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2023-01-31
Enrollment: 467
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare professionals to be recruited will involve general practitioners, palliative care specialists, nursing home physicians, geriatrists, vascular medicine physicians, oncologists, haematologists, pulmonologists, cardiologists, neurologists, and vascular surgeons with equal gender representation and distribution of experienced versus less experienced (young professionals) physicians.

The survey will be conducted in 8 European countries (Denmark, France, Germany, Italy, The Netherlands, Poland, Spain, United Kingdom).

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.

Eligibility criteria: Inclusion Criteria:

Healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients

Exclusion Criteria:

N/A

Primary outcomes:
measure: Current practice patterns across Europe with regard to the use of antithrombotic treatment in end-of-life care of cancer patients
timeFrame: 7 days
measure: Relevance of patient's age for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care
timeFrame: 7 days
measure: Relevance of patient's prognosis for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care
timeFrame: 7 days
measure: Relevance of patient's performance status (Eastern Cooperative Oncology Group
timeFrame: 7 days
measure: Relevance of patient's type of antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy
timeFrame: 7 days
measure: Relevance of patient's indication for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy
timeFrame: 7 days
measure: Relevance of patient's thrombotic risk for the decision on continuation or discontinuation of antithrombotic therapy
timeFrame: 7 days
measure: Relevance of patient's bleeding risk for the decision on continuation or discontinuation of antithrombotic therapy
timeFrame: 7 days
measure: Relevance of patient's symptom burden for the decision on continuation or discontinuation of antithrombotic therapy
timeFrame: 7 days
measure: Relevance of patient's medication burden for the decision on continuation or discontinuation of antithrombotic therapy
timeFrame: 7 days
measure: Relevance of patient's preference (pro/contra continuation) for the decision on continuation or discontinuation of antithrombotic therapy
timeFrame: 7 days
measure: Relevance of physician's experience (with deprescribing) for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire Saint Etienne
city: Mainz
country: Germany
facility: Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz
city: Ragusa
country: Italy
facility: Società Per L'Assistenza Al Malato Oncologico Terminale Onlus
city: Leiden
country: Netherlands
facility: Academisch Ziekenhuis Leiden (Lumc)
city: Rotterdam
country: Netherlands
facility: Erasmus Universitair Medisch Centrum Rotterdam
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Warsaw
country: Poland
facility: Centrum Medyczne Ksztalcenia Podyplomowego
city: Barcelona
country: Spain
facility: Fundació Clínic Per A La Recerca Biomèdica
city: Cardiff
country: United Kingdom
facility: Cardiff University
city: Hull
country: United Kingdom
facility: University of Hull
Study officials:
References: