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

NCT05706740 | Completed

• 1 other identifier: CTH C012
• Study Type: observational
• Target: 467
• Locations: 8 countries
• Sites: 12

Brief 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.

Conditions

Terminal Cancer

Keywords

palliative care; antithrombotic therapy; deprescription; advanced cancer; thrombosis

Outcome Measures

Primary Outcomes (12)

• 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

Interventions

Physician survey on antithrombotic medication during end-of-life care in cancer patients OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients

You may not qualify if:

• N/A

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Leiden University Medical Center: collaborator

Study Sites (12)

Aalborg University Hospital

Aalborg, 9220, Denmark

Location

Assistance Publique - Hôpitaux de Paris

Paris, 75004, France

Location

Centre Hospitalier Universitaire Saint Etienne

Saint-Etienne, 42055, France

Location

Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz

Mainz, 55131, Germany

Location

Società Per L'Assistenza Al Malato Oncologico Terminale Onlus

Ragusa, 97100, Italy

Location

Academisch Ziekenhuis Leiden (Lumc)

Leiden, 2333, Netherlands

Location

Erasmus Universitair Medisch Centrum Rotterdam

Rotterdam, 3015 GD, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Location

Centrum Medyczne Ksztalcenia Podyplomowego

Warsaw, 01813, Poland

Location

Fundació Clínic Per A La Recerca Biomèdica

Barcelona, 08036, Spain

Location

Cardiff University

Cardiff, United Kingdom

Location

University of Hull

Hull, United Kingdom

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: January 31, 2023
• Study Start: February 28, 2023
• Primary Completion: July 18, 2023
• Study Completion: October 31, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

FR (2); DE (1); NL (3); GB (2); PL (1); ES (1); DK (1); IT (1)