Understanding Patterns of Deprescribing Antithrombotic Medication During End-of-Life Care in Cancer Patients Across the European Union
Conditions: Terminal Cancer
Sponsor: Johannes Gutenberg University Mainz

 
 
 
 
 
RESEARCH PROTOCOL  
Towards cancer patient empowerment for optimal 
use of antithrombotic therapy at the end of life 
(SERENITY Physician Survey) 
 
Understanding European patterns of  
deprescribing antithrombotic medication during  
end-of-life care in cancer patients 
 
Version 1.0 of 23 January 2023 
Protocol identifier: CTH C012 
clinicaltrials.gov identifier: NCT05706740 
 
 
 
Coordinating Investigator: Prof. Stavros Konstantinides, MD, PhD 
Center for Thrombosis and Haemostasis 
University Medical Center Mainz 
Langenbeckstraße 1, 55131 Mainz, Germany 
Email: stavros.konstantinides@unimedizin-mainz.de 
Phone: +49 (0)6131 17-8382 

 
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TABLE OF CONTENTS 
ABBREVIATIONS ....................................................................................................................................... 1 
1. 
COORDINATING INVESTIGATOR AND SPONSOR REPRESENTATIVE ........................................................... 2 
2. 
DEFINITIONS .................................................................................................................................... 2 
2.1  
Active cancer ............................................................................................................................. 2 
2.2  
End-of-life care .......................................................................................................................... 2 
3. 
BACKGROUND .................................................................................................................................. 2 
4. 
STUDY OBJECTIVE(S) ......................................................................................................................... 3 
5. 
STUDY DESIGN ................................................................................................................................. 3 
6. 
STUDY POPULATION ......................................................................................................................... 3 
7. 
COUNTRIES INVOLVED ...................................................................................................................... 3 
8. 
(TARGETED) NUMBER OF SUBJECTS .................................................................................................... 3 
9. 
SAMPLE SIZE CONSIDERATIONS .......................................................................................................... 4 
10. DESCRIPTION OF STUDY PROCEDURES ................................................................................................. 4 
11. REGULATORY AND LEGAL REQUIREMENTS ........................................................................................... 5 
12. STUDY DURATION AND TIMELINES ...................................................................................................... 5 
13. STATISTICAL ANALYSIS ...................................................................................................................... 5 
14. REFERENCES .................................................................................................................................... 6 
15. APPENDICES .................................................................................................................................... 7 
15.1  Survey: Questions for pre-registration ...................................................................................... 7 
15.2 Survey: General questions ......................................................................................................... 7 
15.3 Survey: Examples of potential scenarios for the DCE................................................................ 9 
15.4  Survey: Questions on actual case decisions ............................................................................10 
 
ABBREVIATIONS 
ATT 
Antithrombotic therapy 
DCE 
Discrete choice experiment 
DOAC 
Direct oral anticoagulant 
ECOG-PS 
Eastern Clinical Oncology Group performance status 
eCRF 
electronic case report form 
FMR 
Flash mob research 
GDPR 
European General Data Protection Regulation 
LMWH 
Low-molecular-weight heparin 
VKA 
Vitamin-K antagonist 
VTE 
Venous thromboembolism

 
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1. 
COORDINATING INVESTIGATOR AND SPONSOR REPRESENTATIVE 
The Coordinating Investigator of this study is Prof. Stavros Konstantinides, MD, PhD, Center for 
Thrombosis and Hemostasis (CTH) of the University Medical Center of the Johannes Gutenberg 
University Mainz (UMCM), Germany, which acts as representative of the sponsor (Leiden University 
Medical Center, The Netherlands).   
2. 
DEFINITIONS 
2.1  Active cancer  
Cancer diagnosed within the previous six months; recurrent, regionally advanced or metastatic cancer; 
cancer for which treatment has been administered within the past six months; or haematological 
cancer that is not in complete remission. Basal cell or squamous cell carcinoma of the skin are excluded 
from this definition.  
2.2  
End-of-life care 
A patient is considered in end-of-life care in case of a confirmatory negative response of the healthcare 
professional to the question “Would you be surprised if this patient died in the next 6-12 months?”, 
which is an accurate and widely used trigger for referring a patient to specialist palliative care.1,2 
3. 
BACKGROUND 
Deprescribing (i.e., discontinuing medication) 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 
agents. Antithrombotic drugs, e.g., (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), 
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, whilst others 
are being 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 (ATT) 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 countries, 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 ATT in cancer patients. 

 
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4. 
STUDY OBJECTIVE(S) 
¬ 
To explore and describe current European practice patterns with regard to the use of ATT 
in end-of-life care of cancer patients following ‘flash mob research (FMR)’ methodology.  
¬ 
To evaluate and understand the processes and factors that inform decisions concerning 
the deprescription of ATT in the last year of life of cancer patients receiving ATT via a 
discrete choice experiment (DCE) among healthcare professionals, who deal with end-of-
life care in cancer patients, or prescribe such medication to cancer patients. 
5. 
STUDY DESIGN  
International cross-sectional qualitative (flash mob research) study conducted as survey among 
healthcare professionals across Europe. 
6. 
STUDY POPULATION 
SERENITY aims to enrol healthcare professionals from various institutions across Europe, who deal 
with end-of-life care in cancer patients, or prescribe ATT to cancer patients. 
These will involve general practitioners, palliative care specialists, nursing home physicians, geriatrists, 
vascular medicine specialists, oncologists, haematologists, pulmonologists, cardiologists, neurologists, 
and vascular surgeons with equal gender representation and distribution of experienced versus less 
experienced (young professionals) physicians.  
7. 
COUNTRIES INVOLVED  
The survey will be conducted among healthcare professionals mainly from the eight European 
countries represented in the SERENITY consortium:  
¬ 
Denmark  
 
 
¬ 
France  
 
 
 
¬ 
Germany   
 
 
¬ 
Italy 
 
 
 
¬ 
The Netherlands 
 
 
¬ 
Poland 
 
 
 
¬ 
Spain 
 
 
 
¬ 
United Kingdom 
Due to promotion of the project via international networks and social media (s. section 10), we also 
expect participants from other countries and regions. Depending on the number or proportion of 
participants from outside Europe, these will be evaluated separately.  
8. 
(TARGETED) NUMBER OF SUBJECTS  
The study aims to generate data from a total of at least 800 healthcare professionals (i.e., either 100 
each from the countries listed in section 7 or corresponding participant numbers from additional 
countries) and up to 2400 anonymised patients, considering that each healthcare professional will be 
asked to describe actual decisions and anonymous data obtained from medical charts in one to three 
consecutive patients meeting the definitions below at the time of consideration. 

 
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9. 
SAMPLE SIZE CONSIDERATIONS 
In view of the FMR design, there is no formal predetermined sample size. In principle, a successful 
FMR should include a large sample size for reliable and generalizable conclusions.3 
For DCE, the required sample size (N) depends on the number of choice tasks (t), the number of 
alternatives (a), and the number of analysis cells (c) according to the following equation: 
N > 500c/(t×a). Where DCE studies usually require only 100 responses, the minimum sample size to 
show that deprescribing ATT in a certain setting is preferred over continuing the ATT with a statistical 
power β of 80% and a 2-sided significance level α of 0.05 is 190. This is well below the planned number 
of 800 observations.4 
We will monitor the number of preregistered participants and adjust the recruitment plan based on 
the actual accrual.  
10. DESCRIPTION OF STUDY PROCEDURES 
The study will be divided into three phases: the recruitment phase, the FMR-phase and the data 
analysis phase.  
In the recruitment phase, the national coordinators of the project group will advertise the study 
through traditional professional networks as well as their social media channels. Information about 
the study will be distributed via personal communication, relevant scientific organisations and 
journals, and via social media. The healthcare professionals of interest will be invited to pre-register 
for study participation so they can be assigned a unique link to the electronic case report forms (eCRF). 
During the preregistration, characteristics of the pre-registrants will be checked (i.e., sex, age, 
profession, years of experience, the country where they are practicing, and the number of cancer 
patients in palliative care whom they care for on a yearly basis). 
 
In the FMR phase, all preregistered participants will be asked simultaneously to complete the survey 
using the Castor electronic data capture platform within seven days.  
The survey will be divided into the following sections: 
a) General questions regarding end-of-life care (e.g., “When do you consider a patient in end-
of-life care?”) and (de)prescription of antithrombotic medication to cancer patients during 
end-of-life care (e.g., “Have you ever considered deprescribing antithrombotic medicine?”). 
b) A sequence of choice scenarios i.e., hypothetical scenarios that vary with regard to 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), which are 
considered relevant for the decision on continuation or stopping antithrombotic medication 
in the patient population studied. In accordance with the discrete choice experiment (DCE) 
methodology, participants will be asked to select the healthcare intervention (i.e., either 
continuation or discontinuation of the antithrombotic therapy) that in their opinion would 
benefit the patient the most within each choice set. 
c) Participants will be asked to share actual case decisions they made in a maximum of three 
consecutive cases involving patients with active cancer, who were considered to receive end-
of-life care. Fully anonymised data of the patients (sex, age category, primary tumour, tumour 

 
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stage, time point in the course of the disease when the conversation about discontinuation of 
ATT took place, type and indication of ATT) will be collected via multiple-choice questions. 
11. REGULATORY AND LEGAL REQUIREMENTS 
As confirmed by the responsible ethics committee, due to the non-interventional nature of this study 
and since no personal data of patients will be recorded or processed, professional advice and/or 
submission of this protocol to the ethics committee before commencement of the survey is not required.  
Data privacy of participating healthcare professionals will be taken into account in accordance with the 
European General Data Protection Regulation (GDPR). With the exception of the e-mail addresses of survey 
participants for the purpose of forwarding the survey link and information on survey launch and 
completion, no personal data will be stored or processed. As detailed in the information for prospective 
participants, participants implicitly consent to the use of their e-mail addresses for said purposes by pre-
registering.  
Data on patients will be sufficiently coarsened such that no identification will be possible. As an additional 
security measure, this part of the survey will be exported and analyzed separately from the other two 
sections (s. section 9 above). 
12. STUDY DURATION AND TIMELINES 
The total duration of this study is expected to be twelve months.  
The recruitment phase, in which the healthcare professionals will be asked to preregister for study 
participation, will start in March 2023. One week before the study is open for data entry, preregistered 
healthcare professionals will receive an email with details on the study launch. Data collection (i.e., 
the FMR phase) will start in the first week of May 2023 and take seven days. Data analysis and 
publication of results will be conducted from June to October 2023. 
13. STATISTICAL ANALYSIS 
The main analysis of the FMR will be descriptive. Results will be presented for all predefined subgroups 
and with corresponding 95% confidence intervals. Responses to the DCE will be used to generate 
preference coefficients for each level of each attribute using random parameters logit regressions, 
where preference weights represent the relative contribution of the attribute level to the value that 
participants assigned to an alternative management decision.  
The attribute-level coefficients will be expressed as mean preference weights and standard deviations 
of the mean preference weights, each with appropriate 95% confidence interval. The relative 
importance of each attribute will be expressed using the within-attribute difference in preference 
weights as a percentage of the total difference in preference weights across all attributes. For the 
coefficients, the algebraic sign (positive or negative) of a coefficient reflects whether respondents feel 
positive or negative with regard to deprescribing. The value of a coefficient indicates the relative 
importance of the corresponding attribute. The statistical significance of a coefficient (p ≤ 0.05) 
indicates that the respondents underline the importance of the attribute within the options in the 
DCE. 
 

 
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14. REFERENCES 
1. 
Lynn J. Living long in fragile health: the new demographics shape end of life care. Hastings Cent Rep. 
2005;35(6):S14-18. 
2. 
White N, Kupeli N, Vickerstaff V, et al. How accurate is the 'Surprise Question' at identifying patients 
at the end of life? A systematic review and meta-analysis. BMC Med. 2017;15(1):139. 
3. 
Alsma J, van Saase J, Nanayakkara PWB, et al. The Power of Flash Mob Research: Conducting a 
Nationwide Observational Clinical Study on Capillary Refill Time in a Single Day. Chest. 
2017;151(5):1106-1113. 
4. 
de Bekker-Grob EW, Donkers B, Jonker MF, et al. Sample Size Requirements for Discrete-Choice 
Experiments in Healthcare: a Practical Guide. Patient. 2015;8(5):373-384. 
 
 

 
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15. APPENDICES 
15.1  Survey: Questions for pre-registration  
1. Please select your country (Denmark; France; Germany; Italy; The Netherlands; Poland; Spain; 
United Kingdom) 
2. Please select your age category (25-34; 35-44; 45-54; 55-64; 65 or older) 
3. Please select your sex (male; female; other) 
4. Please select your profession (general practitioner; palliative care specialist; nursing home 
physician; geriatrist; vascular medicine specialist; oncologist; haematologist; pulmonologist; 
cardiologist; neurologists; vascular surgeon) 
5. Please select the professional experience group that matches your years of experience (< 5 
years; 5-10 years; 11-15 years; 16-20 years; 21 or more) 
6. Please provide an estimate on the number of patients you see/treat with active cancer each 
year, who are considered to be in end-of-life care. 
This number is important for the upcoming data collection.  
15.2 Survey: General questions 
1. When do you consider a patient in end-of-life care? If the life expectancy is:  
 
A. < 1 year B. < 6 months C. < 3 months D. < 2 weeks 
 
2. When a patient is considered to be in end-of-life care, I XXX prescribe antithrombotic 
medication upon the diagnosis of a thrombotic complication. 
 
A. never B. sometimes C. often D. always 
 
3. Have you ever deprescribed (i.e., terminated) antithrombotic medication in end-of-life care 
of cancer patients?  
 
A. no B yes  
 
In case of no, the participant will not be redirected to certain questions.  
 
4. When a patient is considered to be in end-of-life care, I XXX deprescribe antithrombotic 
medication.  
 
A. never B. sometimes C. often D. always 
 
5. Give an estimate of the frequency per year that you consider deprescribing antithrombotic 
medication in patients, considered to be in end-of-life care: 
XXX /year 
 
6. Give an estimate of the frequency per year that you actually deprescribed antithrombotic 
medication in patients considered to be in end-of-life care: 

 
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XXX /year 
 
7. Do you discuss deprescription of antithrombotic medication in patients at the end of life 
with colleagues?  
A. never B. sometimes C. frequently D. always 
 
8. Please indicate what factors determine whether you prescribe antithrombotic medication in 
patients considered to be in end-of-life care. 
 
9. Please indicate what factors determine whether you deprescribe antithrombotic medication 
in patients considered to be in end-of-life care. 
15.2.1 Examples of factors relevant to questions 8 and 9  
1. Antithrombotic medication:  
− 
DOAC or VKA  
− 
LMWH (therapeutic) 
− 
Antiplatelet agent 
2. Indication for antithrombotic medication:  
− 
Atrial fibrillation 
− 
Treatment of acute VTE event or prevention of (recurrent) VTE 
− 
Mechanical heart valves 
− 
Other indication  
3. Bleeding risk:  
− 
Low 
− 
High  
4. Thrombotic risk: 
− 
Low 
− 
High 
5. Sex: 
− 
Female 
− 
Male 
− 
Other 
6. Age: 
− 
< 40 years 
− 
40-75 years 
− 
> 75 years  
7. Patient’s performance status:  
− 
Eastern Clinical Oncology Group performance status (ECOG-PS) grade 0-2 
[Oken MM et al. Am J Clin Oncol. 1982] 
− 
ECOG-PS grade ≥ 3 
8. Patient prognosis: 
− 
< 6 months 
− 
< 3 months 
− 
< 2 weeks 

 
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9. Patient preference: 
− 
Stop antithrombotic treatment 
− 
Continue antithrombotic treatment  
10. Other  
Free text  
15.3 Survey: Examples of potential scenarios for the DCE 
a) Variable ATT – High thrombotic risk – High bleeding risk – ECOG-PS Grade ≥ 3 
Attributes 
Scenario 1 
Scenario 2 
Scenario 3 
ECOG-PS 
Grade ≥ 3 
Grade ≥ 3 
Grade ≥ 3 
Thrombotic risk 
High 
High 
High 
Bleeding risk 
High 
High 
High 
Antithrombotic medication 
DOAC or VKA 
LMWH (therapeutic) 
Antiplatelet agent 
b) Variable ATT – high thrombotic risk – low bleeding risk – ECOG-PS Grade ≥ 3 
Attributes 
Scenario 1 
Scenario 2 
Scenario 3 
ECOG-PS 
Grade ≥ 3 
Grade ≥ 3 
Grade ≥ 3 
Thrombotic risk 
High 
High 
High 
Bleeding risk 
Low 
Low 
Low 
Antithrombotic medication 
DOAC or VKA 
LMWH (therapeutic) 
Antiplatelet agent 
c) Variable ATT – low thrombotic risk – high bleeding risk – ECOG-PS Grade ≥ 3 
Attributes 
Scenario 1 
Scenario 2 
Scenario 3 
ECOG-PS 
Grade ≥ 3 
Grade ≥ 3 
Grade ≥ 3 
Thrombotic risk 
Low 
Low 
Low 
Bleeding risk 
High 
High 
High 
Antithrombotic medication 
DOAC or VKA 
LMWH (therapeutic) 
Antiplatelet agent 
d) Variable ATT – low thrombotic risk – low bleeding risk – ECOG-PS Grade ≥ 3 
Attributes 
Scenario 1 
Scenario 2 
Scenario 3 
ECOG-PS 
Grade ≥ 3 
Grade ≥ 3 
Grade ≥ 3 
Thrombotic risk 
Low 
Low 
Low 
Bleeding risk 
Low 
Low 
Low 
Antithrombotic medication 
DOAC or VKA 
LMWH (therapeutic) 
Antiplatelet agent 
e) Variable ATT – high thrombotic risk – high bleeding risk – ECOG-PS Grade 0-2 
Attributes 
Scenario 1 
Scenario 2 
Scenario 3 
ECOG-PS 
Grade 0-2 
Grade 0-2 
Grade 0-2 
Thrombotic risk 
High 
High 
High 
Bleeding risk 
High 
High 
High 
Antithrombotic medication 
DOAC or VKA 
LMWH (therapeutic) 
Antiplatelet agent 
 

 
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f) Variable ATT – high thrombotic risk – low bleeding risk – ECOG-PS Grade 0-2 
Attributes 
Scenario 1 
Scenario 2 
Scenario 3 
ECOG-PS 
Grade 0-2 
Grade 0-2 
Grade 0-2 
Thrombotic risk 
High 
High 
High 
Bleeding risk 
Low 
Low 
Low 
Antithrombotic medication 
DOAC or VKA 
LMWH (therapeutic) 
Antiplatelet agent 
g) Variable ATT – low thrombotic risk – high bleeding risk – ECOG-PS Grade 0-2 
Attributes 
Scenario 1 
Scenario 2 
Scenario 3 
ECOG-PS 
Grade 0-2 
Grade 0-2 
Grade 0-2 
Thrombotic risk 
Low 
Low 
Low 
Bleeding risk 
High 
High 
High 
Antithrombotic medication 
DOAC or VKA 
LMWH (therapeutic) 
Antiplatelet agent 
h) Variable ATT – low thrombotic risk – low bleeding risk – ECOG-PS Grade 0-2 
Attributes 
Scenario 1 
Scenario 2 
Scenario 3 
ECOG-PS 
Grade 0-2 
Grade 0-2 
Grade 0-2 
Thrombotic risk 
Low 
Low 
Low 
Bleeding risk 
Low 
Low 
Low 
Antithrombotic medication 
DOAC or VKA 
LMWH (therapeutic) 
Antiplatelet agent 
 
15.4  Survey: Questions on actual case decisions  
In the following (multiple choice) questions, you will be asked to describe one to three actual cases 
of patients with active cancer, who were considered to receive end-of-life care, in which you 
considered deprescription of antithrombotic medication.  
1. Please select the age category of the patient (< 40 years; 40-75 years; 75 years or older) 
2. Please indicate the type of antithrombotic medication involved (DOAC; VKA; LMWH 
(therapeutic); antiplatelet agent) 
3. Please select the indication of the antithrombotic medication (atrial fibrillation; treatment of 
acute VTE-event, prevention of (recurrent) VTE; mechanical heart valves; other indication 
(free text)) 
4. Please indicate the patient’s performance status (ECOG-PS grade 0-2, ECOG-PS ≥ 3) 
5. Please indicate the estimated prognosis of the patient at the time of consideration (< 6 
months; < 3 months; < 2 weeks)  
6. Please specify the setting of the patient at the time of consideration (at home without 
palliative care; at home with palliative care; at rehabilitation facility; at nursing facility; at 
hospice facility; in ‘acute care’ setting; other (free text)). 
7. Please select one or more of the attributes that played a role in your consideration of 
deprescribing the antithrombotic medication; multiple answers are possible (type of 
antithrombotic medication; indication of the antithrombotic medication; bleeding risk; 
thrombotic risk; sex; age; patient’s performance status; patient’s preference; other (free 
text)). 
8. Did you decide to deprescribe the antithrombotic treatment? (yes; no) 

 
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9. If no: 
Which of the following attributes made you decide not to deprescribe the antithrombotic 
drugs? Multiple choices are possible. 
Experience with deprescribing: not enough; enough 
Symptom burden: high  
Burden of medication (administration): low 
Thrombotic risk: high  
Bleeding risk: low 
Antithrombotic medication indication: atrial fibrillation; acute VTE-event, prevention of 
(recurrent) VTE; mechanical heart valves; other indication (free text) 
Sex: male; female, other (selection to be made) 
Age: (< 40 years; 40-64 years; 65-74 years; 75 years or older) 
Patient’s performance status: ECOG-PS 0-2 
Patient’s prognosis: < 2 weeks; < 3 months; < 6 months (selection to be made) 
Patient’s preference: continue antithrombotic treatment 
Other (free text) 
10. If yes:  
Which of the following attributes made you decide to deprescribe the antithrombotic drugs? 
Multiple choices are possible. 
Experience with deprescribing: enough 
Symptom burden: low  
Burden of medication (administration): high 
Thrombotic risk: low 
Bleeding risk: high 
Antithrombotic medication indication: atrial fibrillation; acute VTE-event, prevention of 
(recurrent) VTE; mechanical heart valves; other indication (free text) 
Sex: male; female, other (selection to be made) 
Age: (< 40 years; 40-64 years; 65-74 years; 75 years or older) 
Patient’s performance status: ECOG-PS grade ≥ 3 
Patient’s prognosis: < 2 weeks; < 3 months; < 6 months (selection to be made) 
Patient’s preference: stop antithrombotic treatment 
Other (free text) 
Tumour-specific 
11. Please select the type of cancer (breast; lung; upper gastro-intestinal (GI); lower GI; 
endocrine; genito-urinary tract; brain; haematological; skin (excluding squamous/basal cell 
carcinoma); combination (select more than one); other (free text) 
12. Please select the stage of cancer (localized; regional; distant metastasis; not applicable)  
13. Please select the cancer treatment at the time of consideration/decision – multiple options 
possible (none; surgery (in the previous 3 months); radiation therapy (in the previous month); 
chemotherapy (in the previous month); immunotherapy (in the previous month) 
14. Please select the line of cancer treatment (first-line, second-line, third-line, fourth-line, not 
applicable