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

Terminal Cancer Clinical Trial

— SERENITY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706740
• Other study ID #: CTH C012
• Status: Recruiting
• Start date: February 28, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2023
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: October 31, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Terminal Cancer

Intervention

Other:
• Physician survey on antithrombotic medication during end-of-life care in cancer patients
Participating healthcare professionals will be asked to complete the survey electronically within seven days. The survey will consist of general questions (i.e., "Have you ever considered deprescribing antithrombotic medicine"?), a discrete choice experiment (DCE), and questions involving actual decision-making in patients. For the DCE, participants will be presented a sequence of choice sets with (hypothetical) scenarios that vary along several characteristics (attributes; e.g., bleeding risk, thrombotic risk). Attributes will be further specified by varying choice levels (attribute levels; e.g., low or high bleeding risk). Participants will be asked to select the healthcare intervention with the highest benefit for the patient according to their opinion. Finally, participants will be asked to describe actual decisions they made in max. three consecutive patients with active cancer, who were considered to receive end-of-life care.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
France	Assistance Publique - Hôpitaux de Paris	Paris
France	Centre Hospitalier Universitaire Saint Etienne	Saint-Étienne
Germany	Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz	Mainz
Italy	Società Per L'Assistenza Al Malato Oncologico Terminale Onlus	Ragusa
Netherlands	Academisch Ziekenhuis Leiden (Lumc)	Leiden
Netherlands	Erasmus Universitair Medisch Centrum Rotterdam	Rotterdam
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Poland	Centrum Medyczne Ksztalcenia Podyplomowego	Warsaw
Spain	Fundació Clínic Per A La Recerca Biomèdica	Barcelona
United Kingdom	Cardiff University	Cardiff
United Kingdom	University of Hull	Hull

Sponsors (2)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Leiden University Medical Center

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Relevance of patient's age for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care		7 days
Primary	Relevance of patient's prognosis for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care		7 days
Primary	Relevance of patient's performance status (Eastern Cooperative Oncology Group	(ECOG)) for the decision on continuation or discontinuation of antithrombotic therapy	7 days
Primary	Relevance of patient's type of antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy		7 days
Primary	Relevance of patient's indication for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy		7 days
Primary	Relevance of patient's thrombotic risk for the decision on continuation or discontinuation of antithrombotic therapy		7 days
Primary	Relevance of patient's bleeding risk for the decision on continuation or discontinuation of antithrombotic therapy		7 days
Primary	Relevance of patient's symptom burden for the decision on continuation or discontinuation of antithrombotic therapy		7 days
Primary	Relevance of patient's medication burden for the decision on continuation or discontinuation of antithrombotic therapy		7 days
Primary	Relevance of patient's preference (pro/contra continuation) for the decision on continuation or discontinuation of antithrombotic therapy		7 days
Primary	Relevance of physician's experience (with deprescribing) for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy		7 days