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JOURNAL ONKOLOGIE – STUDIE
SERENITY

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

Rekrutierend

NCT-Nummer:
NCT05706740

Studienbeginn:
Februar 2023

Letztes Update:
23.03.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Death

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Johannes Gutenberg University Mainz

Collaborator:
Leiden University Medical Center

Studienlocations
(3 von 12)

Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Stavros V. Konstantinides
Phone: +40 6131 17-8382
E-Mail: Stavros.Konstantinides@unimedizin-mainz.de
» Ansprechpartner anzeigen
Centre Hospitalier Universitaire Saint Etienne
42055 Saint-Étienne
FranceRekrutierend» Google-Maps
Ansprechpartner:
Laurent Bertoletti
Phone: +33 662097024
E-Mail: laurent.bertoletti@gmail.com
» Ansprechpartner anzeigen
Società Per L'Assistenza Al Malato Oncologico Terminale Onlus
97100 Ragusa
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Stefano Martorana
Phone: +39 3395414798
E-Mail: progettazione@samot.org
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Current practice patterns across Europe with regard to the use of antithrombotic treatment in end-of-life care of cancer patients (Time Frame - 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)

2. Relevance of patient's age for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care (Time Frame - 7 days)

3. Relevance of patient's prognosis for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care (Time Frame - 7 days)

4. Relevance of patient's performance status (Eastern Cooperative Oncology Group (Time Frame - 7 days):
(ECOG)) for the decision on continuation or discontinuation of antithrombotic therapy

5. Relevance of patient's type of antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy (Time Frame - 7 days)

6. Relevance of patient's indication for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy (Time Frame - 7 days)

7. Relevance of patient's thrombotic risk for the decision on continuation or discontinuation of antithrombotic therapy (Time Frame - 7 days)

8. Relevance of patient's bleeding risk for the decision on continuation or discontinuation of antithrombotic therapy (Time Frame - 7 days)

9. Relevance of patient's symptom burden for the decision on continuation or discontinuation of antithrombotic therapy (Time Frame - 7 days)

10. Relevance of patient's medication burden for the decision on continuation or discontinuation of antithrombotic therapy (Time Frame - 7 days)

11. Relevance of patient's preference (pro/contra continuation) for the decision on continuation or discontinuation of antithrombotic therapy (Time Frame - 7 days)

12. Relevance of physician's experience (with deprescribing) for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy (Time Frame - 7 days)

Geprüfte Regime

  • 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.

Quelle: ClinicalTrials.gov


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