Periodic Reporting for period 1 - RELEVIUM (Improving quality of life of advanced pancreatic cancer patients through an AI-guided multimodal intervention, combining pain and cachexia management, nutrition, and physical activity)
Periodo di rendicontazione: 2022-09-01 al 2024-02-29
Pancreatic cancer has the lowest survival rate among other cancers and is responsible for a high number of deaths every year in the EU. Its treatment is usually palliative, aiming at slowing tumour progression and at symptom management.
The main hypothesis of RELEVIUM is that quality of life (QoL) of advanced pancreatic cancer patients can be significantly improved by reducing pain and cachexia through highly personalised nutrition, physical activity, and pain management strategies, in addition to chemotherapy treatment. To achieve this, RELEVIUM will empower patients with digital tools that facilitate patient-doctor communication and enable them to self-manage their disease.
RELEVIUM will use a multi-sensor smartwatch and an innovative remote ultrasound patch, AI algorithms for continuous remote monitoring of pain and sarcopenia, as well as for decision support, and patient and caregiver mobile applications.
Combined, these tools will provide a stream of evidence on symptom progression and will enable physicians to apply personalised care plans.
RELEVIUM brings together an interdisciplinary team of experts and involves patients and their caregivers in an iterative co-creation process. The project conducts first a feasibility and data collection study (RELEVIUM-FDC). The FDC study aims at optimizing patient adherence and compliance, and at collecting data for the development of the intervention. The subsequent five-centre randomized clinical trial (RELEVIUM-RCT) evaluates the efficacy of the proposed personalised care plans for advanced pancreatic cancer patients in terms of their QoL. Several secondary outcomes will be investigated, such as the cost-effectiveness of the intervention, its potential in increasing health equity and in relieving the stress burden on the patient families.
The study outcomes will result in recommendations for integrating remote monitoring and improving QoL outcomes in palliative care for advanced pancreatic cancer.
The main hypothesis of RELEVIUM is that quality of life (QoL) of advanced pancreatic cancer patients can be significantly improved by reducing pain and cachexia through highly personalised nutrition, physical activity, and pain management strategies, in addition to chemotherapy treatment. To achieve this, RELEVIUM will empower patients with digital tools that facilitate patient-doctor communication and enable them to self-manage their disease.
RELEVIUM will use a multi-sensor smartwatch and an innovative remote ultrasound patch, AI algorithms for continuous remote monitoring of pain and sarcopenia, as well as for decision support, and patient and caregiver mobile applications.
Combined, these tools will provide a stream of evidence on symptom progression and will enable physicians to apply personalised care plans.
RELEVIUM brings together an interdisciplinary team of experts and involves patients and their caregivers in an iterative co-creation process. The project conducts first a feasibility and data collection study (RELEVIUM-FDC). The FDC study aims at optimizing patient adherence and compliance, and at collecting data for the development of the intervention. The subsequent five-centre randomized clinical trial (RELEVIUM-RCT) evaluates the efficacy of the proposed personalised care plans for advanced pancreatic cancer patients in terms of their QoL. Several secondary outcomes will be investigated, such as the cost-effectiveness of the intervention, its potential in increasing health equity and in relieving the stress burden on the patient families.
The study outcomes will result in recommendations for integrating remote monitoring and improving QoL outcomes in palliative care for advanced pancreatic cancer.
During the first 18 months, the following activities were performed:
Analysis of end-user needs and requirements and submission of D1.1
Conduction and update of data management plan (DMP) and E/PIA.
Signing of Joint Controllers Agreement (data sharing agreement).
Organization of a GDPR and ethics related workshop.
Implementation of an end-to-end functioning beta version of the RELEVIUM system.
Preliminary versions of each technological component have been designed, integrated and deployed into the system.
User registration and activation procedures have also been defined and tested.
CI/CD system and architecture was defined, developed and deployed.
Developed and designed the multimodal intervention plan as part of the RCT study protocol.
Developed and finalised the RCT study protocol and patient documentation along with all of the clinical partners and
Prepared the ethical application submission packages for the five clinical study centres.
First draft of parameter list for the analysis of results and recommendations.
Completed communication and dissemination plan.
Creation and continuous update of project website and social media channels.
Developed exploitation and business plan.
Submission of deliverable D6.1 - Project Manual at M3.
Organisation and management of assembly meetings, WP leaders meeting and clinical partner meetings.
Financial management, distribution of funds, provision of Consortium Agreement and provision and finalisation of Joint Controllers Agreement.
Networking in two cluster meetings (AIW and QoL)
Implemented Quality Insurance Plan to assure quality of deliverables and risk management procedures.
Provision of two risk mitigation plans.
Appointment of independent external ethics advisor and completion of D7.1 OEI (other ethical issues).
Analysis of end-user needs and requirements and submission of D1.1
Conduction and update of data management plan (DMP) and E/PIA.
Signing of Joint Controllers Agreement (data sharing agreement).
Organization of a GDPR and ethics related workshop.
Implementation of an end-to-end functioning beta version of the RELEVIUM system.
Preliminary versions of each technological component have been designed, integrated and deployed into the system.
User registration and activation procedures have also been defined and tested.
CI/CD system and architecture was defined, developed and deployed.
Developed and designed the multimodal intervention plan as part of the RCT study protocol.
Developed and finalised the RCT study protocol and patient documentation along with all of the clinical partners and
Prepared the ethical application submission packages for the five clinical study centres.
First draft of parameter list for the analysis of results and recommendations.
Completed communication and dissemination plan.
Creation and continuous update of project website and social media channels.
Developed exploitation and business plan.
Submission of deliverable D6.1 - Project Manual at M3.
Organisation and management of assembly meetings, WP leaders meeting and clinical partner meetings.
Financial management, distribution of funds, provision of Consortium Agreement and provision and finalisation of Joint Controllers Agreement.
Networking in two cluster meetings (AIW and QoL)
Implemented Quality Insurance Plan to assure quality of deliverables and risk management procedures.
Provision of two risk mitigation plans.
Appointment of independent external ethics advisor and completion of D7.1 OEI (other ethical issues).