Terminal CancerSERENITYNCT05706740
Towards Cancer Patient Empowerment for Optimal Use of Antithrombotic Therapy at the End of Life
An observational study of Terminal Cancer, run by Johannes Gutenberg University Mainz at 12 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Terminal Cancer
- What is being tested?
- Physician survey on antithrombotic medication during end-of-life care in cancer patients
- How many people
- 467 participants
- Where
- 12 sitesin 8 countries
- Study dates
- 28 Feb 2023to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- Healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients
Who cannot join
- N/A
Trial locations and contacts
12 sites in 8 countries.
12 sites in 8 countries
Netherlands3 sites
Academisch Ziekenhuis Leiden (Lumc)
Leiden, 2333
Erasmus Universitair Medisch Centrum Rotterdam
Rotterdam, 3015 GD
Universitair Medisch Centrum Utrecht
Utrecht
France2 sites
Assistance Publique - Hôpitaux de Paris
Paris, 75004
Centre Hospitalier Universitaire Saint Etienne
Saint-Etienne, 42055
United Kingdom2 sites
Cardiff University
Cardiff
University of Hull
Hull
Germany1 site
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131
Italy1 site
Società Per L'Assistenza Al Malato Oncologico Terminale Onlus
Ragusa, 97100
About this study
Official title: 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.
Read the 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.
- Conditions
- Terminal Cancer
- Being tested
- Physician survey on antithrombotic medication during end-of-life care in cancer patients
- Keywords
- palliative care, antithrombotic therapy, deprescription, advanced cancer, thrombosis
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician survey on antithrombotic medication during end-of-life care in cancer patientsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 days
Relevance of patient's age for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care
Measured: 7 days
Relevance of patient's prognosis for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care
Measured: 7 days
Relevance of patient's performance status (Eastern Cooperative Oncology Group
(ECOG)) for the decision on continuation or discontinuation of antithrombotic therapy
Measured: 7 days
Relevance of patient's type of antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy
Measured: 7 days
Relevance of patient's indication for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy
Measured: 7 days
Relevance of patient's thrombotic risk for the decision on continuation or discontinuation of antithrombotic therapy
Measured: 7 days
Relevance of patient's bleeding risk for the decision on continuation or discontinuation of antithrombotic therapy
Measured: 7 days
Relevance of patient's symptom burden for the decision on continuation or discontinuation of antithrombotic therapy
Measured: 7 days
Relevance of patient's medication burden for the decision on continuation or discontinuation of antithrombotic therapy
Measured: 7 days
Relevance of patient's preference (pro/contra continuation) for the decision on continuation or discontinuation of antithrombotic therapy
Measured: 7 days
Relevance of physician's experience (with deprescribing) for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start28 Feb 2023
- Primary completion18 Jul 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Terminal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Principal investigator, Prof. Stavros Konstantinides, MD, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706740
- Sponsor's protocol ID
- CTH C012
- Acronym
- SERENITY
- Status last verified
- Oct 2024
- First submitted
- 23 Jan 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Patterns of Deprescribing Antithrombotic Medication During End-of-Life Care in Cancer Patients Across the European Union
- ClinicalTrials.gov ID
- NCT05706740
- Acronym / sponsor ID
- SERENITY / CTH C012
- Conditions
- Terminal Cancer
- Keywords
- palliative care, antithrombotic therapy, deprescription, advanced cancer, thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician survey on antithrombotic medication during end-of-life care in cancer patientsParticipating 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. | Other | – |
Primary outcome
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)
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
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
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
Relevance of patient's type of antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy
Time frame: 7 days
Relevance of patient's indication for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy
Time frame: 7 days
Relevance of patient's thrombotic risk for the decision on continuation or discontinuation of antithrombotic therapy
Time frame: 7 days
Relevance of patient's bleeding risk for the decision on continuation or discontinuation of antithrombotic therapy
Time frame: 7 days
Relevance of patient's symptom burden for the decision on continuation or discontinuation of antithrombotic therapy
Time frame: 7 days
Relevance of patient's medication burden for the decision on continuation or discontinuation of antithrombotic therapy
Time frame: 7 days
Relevance of patient's preference (pro/contra continuation) for the decision on continuation or discontinuation of antithrombotic therapy
Time frame: 7 days
Relevance of physician's experience (with deprescribing) for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Terminal Cancer, run by Johannes Gutenberg University Mainz at 12 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands, France, United Kingdom, Denmark, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.