Towards Cancer Patient Empowerment for Optimal Use of Antithrombotic Therapy at the End of Life (SERENITY)

Understanding Patterns of Deprescribing Antithrombotic Medication During End-of-Life Care in Cancer Patients Across the European Union

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.

Study Overview

• Status: Recruiting
• Conditions: Terminal Cancer
• Intervention / Treatment: Other: Physician survey on antithrombotic medication during end-of-life care in cancer patients

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.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9220
    • Recruiting
    • Aalborg University Hospital
    • Contact: Anette Arbjerg Højen; Phone Number: +45 29 29 91 14; Email: a.wind@rn.dk
• France
  • Paris, France, 75004
    • Recruiting
    • Assistance Publique - Hôpitaux de Paris
    • Contact: Isabelle Mahe; Phone Number: +33 6 21 51 30 16; Email: isabelle.mahe@aphp.fr
  • Saint-Étienne, France, 42055
    • Recruiting
    • Centre Hospitalier Universitaire Saint Etienne
    • Contact: Laurent Bertoletti; Phone Number: +33 662097024; Email: laurent.bertoletti@gmail.com
• Germany
  • Mainz, Germany, 55131
    • Recruiting
    • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
    • Contact: Stavros V. Konstantinides; Phone Number: +40 6131 17-8382; Email: Stavros.Konstantinides@unimedizin-mainz.de
• Italy
  • Ragusa, Italy, 97100
    • Recruiting
    • Società Per L'Assistenza Al Malato Oncologico Terminale Onlus
    • Contact: Stefano Martorana; Phone Number: +39 3395414798; Email: progettazione@samot.org
• Netherlands
  • Leiden, Netherlands, 2333
    • Recruiting
    • Academisch Ziekenhuis Leiden (LUMC)
    • Contact: Frederikus A. Klok; Phone Number: +31 6 5196 9382; Email: f.a.klok@lumc.nl
  • Rotterdam, Netherlands, 3015 GD
    • Recruiting
    • Erasmus Universitair Medisch Centrum Rotterdam
    • Contact: Marieke Kruip; Phone Number: +3130107035150; Email: m.kruip@erasmusmc.nl
  • Utrecht, Netherlands
    • Recruiting
    • Universitair Medisch Centrum Utrecht
    • Contact: Geertjan Geersing; Phone Number: +31 6 54394005; Email: g.j.geersing@umcutrecht.nl
• Poland
  • Warsaw, Poland, 01813
    • Recruiting
    • Centrum Medyczne Ksztalcenia Podyplomowego
    • Contact: Sebastian Szmit; Phone Number: +48 691752601; Email: s.szmit@gmail.com
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Fundació Clínic Per A La Recerca Biomèdica
    • Contact: Carme Font; Phone Number: +34 678398656; Email: cfont@clinic.cat
• United Kingdom
  • Cardiff, United Kingdom
    • Recruiting
    • Cardiff University
    • Contact: Simon Noble; Phone Number: +44 2920687500; Email: noblesi1@cardiff.ac.uk
  • Hull, United Kingdom
    • Recruiting
    • University of Hull
    • Contact: Mark Pearson; Phone Number: +44 1482 463335; Email: mark.pearson@hull.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current practice patterns across Europe with regard to the use of antithrombotic treatment in end-of-life care of cancer patients	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)	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 prognosis for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care		7 days
Relevance of patient's performance status (Eastern Cooperative Oncology Group	(ECOG)) for the decision on continuation or discontinuation of antithrombotic therapy	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 indication for 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 bleeding risk for the decision on continuation or discontinuation of antithrombotic therapy		7 days
Relevance of patient's symptom burden 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
Relevance of patient's preference (pro/contra continuation) 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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Collaborators: Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: palliative care; advanced cancer; thrombosis; antithrombotic therapy; deprescription
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: CTH C012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No