Periodic Reporting for period 2 - SERENITY (Towards Cancer Patient Empowerment for Optimal Use of Antithrombotic Therapy at the End of Life)
Período documentado: 2024-04-01 hasta 2025-09-30
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, ATT is often continued until death, resulting in excess bleeding, higher healthcare costs, and increased disease burden. SERENITY will develop an information-driven, palliative care shared decision-making process enabled by a userfriendly, easily accessible, web-based shared decision support tool (SDST) that will facilitate treatment decisions regarding appropriate use of ATT in cancer patients at the end of life. SERENITY will use a comprehensive approach consisting of a combination of realist review, flash mob research, three epidemiologic studies in NL, UK, and DK, and qualitative interviews. The results of these studies will be used in a Delphi process to reach consensus on the optimal design of the intervention. Using the consensus reached in the Delphi process, the SDST will be designed to be patient-specific with adaption to gender, cancer-related, cultural, and socioeconomic factors. Proceeding, the SDST will be tested and optimised in a Randomised Clinical Trial. A targeted implementation and exploitation plan will be developed to enable the use of the SERENITY approach across Europe, as well as incorporation in national and pan-European clinical guidelines and policies. The intervention will ultimately lead to appropriate use of ATT, prevention of bleeding
complications, and considerable cost savings in addition to improved quality of life and treatment satisfaction of patients, their carers, and involved healthcare professionals. The intervention will empower cancer patients and their carers, enabling them to make their own choices. The intervention will reduce the disease burden of hundreds of thousands of people living with cancer receiving palliative care each year, throughout all EU regions.
complications, and considerable cost savings in addition to improved quality of life and treatment satisfaction of patients, their carers, and involved healthcare professionals. The intervention will empower cancer patients and their carers, enabling them to make their own choices. The intervention will reduce the disease burden of hundreds of thousands of people living with cancer receiving palliative care each year, throughout all EU regions.
All work in WP 1 has been completed according to plan. Manuscripts of both the realist review and the flashmob study have been published, and a methodological paper on how to perform a realist review in the area of research has been submitted for publication.
The different parts of WP2 in the different countries have been aligned in the first year of the consortium: definitions of important determinants and variables (often based on ICD10 codes) were established to make sure that the data generated in the different countries would be comparable. The focus and methodology of the different epidemiological analyses were established to make sure that each individual study would be complementary to the others. All data analysis has been completed and shared with the consortium, so the other WPs could make optimal use of the findings. Manuscripts for each individual study have been submitted and accepted for publication, except for the Leiden data. As planned, the data from WP2 have largely informed the content of the shared decision tool. A position paper on how to standardize epidemiological studies in the field of palliative care and with a focus on ATT, bleeding and thrombotic complications, has been submitted for publication. Utrecht paper accepted for publication but not yet available online. A final synthesis paper, to summarize all findings from this WP2 and put those in the correct perspective, has been planned.
WP3: all interviews have been completed within the timeframe proposed in the application, and the mean results have been synthesized and shared & discussed with the consortium, as they form a very important basis for WP 4-6. The manuscript on patient perspective has been published, the one on physician perspective has been submitted. A methodological paper on how to perform such studies across several European countries as well as a mixed-methods paper taking into account findings from WP1 & 3 are being prepared.
WP4: the Delphi study has been completed and was fully based on the findings of WP1-3 and largely guided by the PPI work performed in the consortium. The study protocol was published and the final study report has been submitted for publication.
The findings of WP4 have determined details of WP5 and WP6, as planned.
WP5: a functioning and well tested tool has been developed and is being used in the trial in 4 languages (Dutch, English, Spanish and Polish).
WP6: The trial protocol, which was under development from day one of the consortium, has been completed, overcoming many challenges relevant to performing a pan-European study in end-of-life care. Much work has been done to optimally determine the 1) population of interest, 2) moment of application of the tool, 3) definition of the endpoint, that now reflects a patient relevant outcome that has been endorsed both by patients as well as by health care professionals. The first patient was enrolled on November 14th in Leiden, and start of the study in all countries is expected on January first 2025. It is a huge achievement by the study team to get to this point on schedule, underlying the dedication of the complete consortium.
WP7: Abstracts discussing findings of the WPs were submitted to several conferences and presented. Moreover, the aims, methodology, and preliminary results of the scientific work in SERENITY were presented at several meetings and webinars. All SERENITY consortium members are being kept up to date on news, progress reports and achievements by monthly newsletters and the consortium meetings. Also, high-quality instruction materials for how to use the tool have been developed. This is crucial for the study physicians and nurses at this point in time, but will also be applicable to the wider public when the tool will be made available online.
The different parts of WP2 in the different countries have been aligned in the first year of the consortium: definitions of important determinants and variables (often based on ICD10 codes) were established to make sure that the data generated in the different countries would be comparable. The focus and methodology of the different epidemiological analyses were established to make sure that each individual study would be complementary to the others. All data analysis has been completed and shared with the consortium, so the other WPs could make optimal use of the findings. Manuscripts for each individual study have been submitted and accepted for publication, except for the Leiden data. As planned, the data from WP2 have largely informed the content of the shared decision tool. A position paper on how to standardize epidemiological studies in the field of palliative care and with a focus on ATT, bleeding and thrombotic complications, has been submitted for publication. Utrecht paper accepted for publication but not yet available online. A final synthesis paper, to summarize all findings from this WP2 and put those in the correct perspective, has been planned.
WP3: all interviews have been completed within the timeframe proposed in the application, and the mean results have been synthesized and shared & discussed with the consortium, as they form a very important basis for WP 4-6. The manuscript on patient perspective has been published, the one on physician perspective has been submitted. A methodological paper on how to perform such studies across several European countries as well as a mixed-methods paper taking into account findings from WP1 & 3 are being prepared.
WP4: the Delphi study has been completed and was fully based on the findings of WP1-3 and largely guided by the PPI work performed in the consortium. The study protocol was published and the final study report has been submitted for publication.
The findings of WP4 have determined details of WP5 and WP6, as planned.
WP5: a functioning and well tested tool has been developed and is being used in the trial in 4 languages (Dutch, English, Spanish and Polish).
WP6: The trial protocol, which was under development from day one of the consortium, has been completed, overcoming many challenges relevant to performing a pan-European study in end-of-life care. Much work has been done to optimally determine the 1) population of interest, 2) moment of application of the tool, 3) definition of the endpoint, that now reflects a patient relevant outcome that has been endorsed both by patients as well as by health care professionals. The first patient was enrolled on November 14th in Leiden, and start of the study in all countries is expected on January first 2025. It is a huge achievement by the study team to get to this point on schedule, underlying the dedication of the complete consortium.
WP7: Abstracts discussing findings of the WPs were submitted to several conferences and presented. Moreover, the aims, methodology, and preliminary results of the scientific work in SERENITY were presented at several meetings and webinars. All SERENITY consortium members are being kept up to date on news, progress reports and achievements by monthly newsletters and the consortium meetings. Also, high-quality instruction materials for how to use the tool have been developed. This is crucial for the study physicians and nurses at this point in time, but will also be applicable to the wider public when the tool will be made available online.
PPI Patient and Public Involvement – Cardiff University
We aim to include meaningful patient and public involvement across all work packages. With the range of methodologies used across all work packages, a strategic plan will be applied to enable collaborations between a team of PPIE experts, work-package leads and research teams. To enable this, we have established a Patient and Public Involvement and Engagement (PPIE) work package and PPIE team for SERENITY.
The main aims of the PPI team are:
• to support the SERENITY study research teams to engage with patient and public contributors
• to help ensure that the research is appropriately conducted
• to help ensure the research is of high quality
• to optimise the impact of the research by ensuring that the development and implementation of the SDMST in local health services is suitable for the needs of local populations.
An advanced program for patient partner involvement (PPI) has been set up, and was integrated in all work packages. Several abstracts regarding this work have been presented on international congresses that had either a focus on palliative care or on shared decision making. A position paper on how to optimally integrate PPI in (EU) research consortia has been published. The PPI work has greatly guided the work in WP4, 5 & 6.
We aim to include meaningful patient and public involvement across all work packages. With the range of methodologies used across all work packages, a strategic plan will be applied to enable collaborations between a team of PPIE experts, work-package leads and research teams. To enable this, we have established a Patient and Public Involvement and Engagement (PPIE) work package and PPIE team for SERENITY.
The main aims of the PPI team are:
• to support the SERENITY study research teams to engage with patient and public contributors
• to help ensure that the research is appropriately conducted
• to help ensure the research is of high quality
• to optimise the impact of the research by ensuring that the development and implementation of the SDMST in local health services is suitable for the needs of local populations.
An advanced program for patient partner involvement (PPI) has been set up, and was integrated in all work packages. Several abstracts regarding this work have been presented on international congresses that had either a focus on palliative care or on shared decision making. A position paper on how to optimally integrate PPI in (EU) research consortia has been published. The PPI work has greatly guided the work in WP4, 5 & 6.