Project Structure

MyPal includes the following work packages:

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WP1: Ethical Framework & Drivers for Leveraging Patient Reported Outcome Systems

WP1 will define the ethical framework of the proposed intervention and monitor the compliance of the design and implementation phase with this framework. It will also identify and analyse all the important factors that may drive PRO systems towards their application and acceptance in palliative care. WP1 will set the scene for the successful adoption of advanced PRO systems in palliative care with an explicit focus to cancer patients.

WP2: Intervention Design

WP2 will define the clinical study protocols and the overall strategy of the MyPal intervention. It will first define the context of the targeted diseases as well as user scenarios, in a comprehensive way for all the involved stakeholders. Following the user-centred design approach, WP2 will identify the user needs and pose requirements to the technical WPs of the project, namely, WP3, WP4 and WP5. It will also contribute in the testing phase of the MyPal tools before entering the clinical study implementation phase.

WP3: Patient Reported Outcome Tool for Adults

WP3 will deliver the ePRO tool that will be used in the MyPal-ADULT RCT study. It will translate the user requirements defined in WP2 into technical specifications of the ePRO tool. WP3 will design and specify the architecture of this development, implement the respective components, address multilinguality issues, and employ the necessary integration plan and testing framework before using these components in the MyPal-ADULT study. The testing phase will provide feedback for the potential refinement of tools and their proper deployment in the respective medical sites.

WP4: Patient Reported Outcome Tool for Children

WP4 will deliver the ePRO tool that will be used for the MyPal-CHILD observational study. Similar to WP3, WP4 will translate the user requirements defined in WP2 into technical specifications of the ePRO tool for children. This development will rely on a gamification approach, which has been perceived as an attractive and engaging way to elicit information regarding the disease from children suffering from cancer. The envisioned game will create a comprehensive environment for both children and their parents to interact with, in order to report signs/symptoms and psychological aspects that children experience due to the disease to their healthcare providers.

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WP5: Tools for Exploiting PROs and Advancing ePRO Systems

WP5 aims to advance ePRO systems by exploiting the gathered data from WP3 and WP4 ePRO tools. In particular, it will develop novel tools to reinforce palliative care of cancer patients, such as a patient-healthcare provider communication tool, a shared decision-making tool, an integrated palliative care tool, a tool for identifying early signs/symptoms of major importance for the proper disease management based on predictive analytics, and a tool for guiding patients in understanding and coping with their symptoms. WP5 will also integrate all the MyPal tools (WP3, WP4 and WP5 developments), in order to offer an exploitable outcome of the technical solution.

WP6: Clinical Studies Implementation, Evaluation and Impact Assessment

WP6 will implement the MyPal intervention as two clinical studies, i.e. an RCT for adults – (MyPal-ADULT) and an observational study for children (MyPal-CHILD) in the six medical sites participating in the project. The clinical studies will be conducted for a 21-month period in compliance with the ethical framework and the study protocols defined in WP2. WP6 will also define and conduct a comprehensive evaluation and impact assessment study of the intervention, elaborating on both effectiveness and cost-effectiveness, according to the primary and secondary objectives / endpoints defined for each clinical study in WP2. Based on the evaluation outcomes, WP6 will conclude with potential adaptations of the MyPal tools employed in the clinical studies.

WP7: Dissemination & Exploitation

WP7 will make the project visible to a wide audience, disseminate the results to relevant groups and promote an innovative solution for advancing reporting and exploiting patient outcomes in palliative care for cancer patients, elaborating on the intersection between palliative care and digital health at large. Therefore, WP7 will disseminate the MyPal intervention (user needs and analysis, technical developments, clinical studies and findings from the impact assessment studies) to all key actors in the field and – at the same time – integrate their feedback to the project Tasks. On top of that, exploitation plans will be derived, while IPR management will be performed. WP7 will elaborate on an appropriate business model and the go-to-market strategy for MyPal results.

WP8: Project Management

The project management will ensure the achievement of the project objectives within time and budget constraints, by planning, organising and controlling the integrated effort of the Consortium. This will be a continuous task throughout the project entailing project management, scientific and technical coordination, risk assessment and mitigation planning, as well as quality control mechanisms.

Implementation Plan Overview

Phase A: Intervention Design (MyPal Study Protocols and User Requirements)

This phase will set the scene for the MyPal intervention. It will identify the limitations of current PRO systems and design a patient engagement strategy, having at its cornerstone the adaptation of technology to the individual patient needs. Thus, it will define all the details of the intervention, in terms of the user (patients, family members, healthcare providers) needs and their characteristics as well as the PROs that will be elaborated per patient group, coupled with the appropriate technological artifacts to be used. Major emphasis will be given on defining the ethical framework for conducting the proposed clinical studies. Use case scenarios will be defined for all implicated stakeholders (patients, family members, healthcare providers) to better illustrate MyPal use in realistic situations. It will comprehensively design the study protocols by defining in detail the primary and secondary endpoints, the eligibility criteria (both inclusion and exclusion), the procedure for patient recruitment, the arrangements that will be necessary per medical site, etc.

Phase B: Technical Implementation-Adaptation of MyPal PRO Components and Tools

The technical implementation of the intervention will rely on existing tools (available to MyPal from previous/ongoing projects and from the industrial partners of the Consortium) that shall be adapted to the scope of the proposed interventions in the chosen cancer types. User requirements defined in the previous phase will be mapped to technical specifications of the tools that will be used in the clinical studies. The implementation will follow a rigorous and agile process, offering prototypes of the tools in the first year of the project and ensuring close and constructive collaboration among all stakeholders (technology providers, patients, family members, and healthcare providers). Thus, Phase A and Phase B will run in parallel and interact closely following the user-centred design (UCD) approach. Before conducting the clinical studies, a pilot-testing phase will be conducted, aiming to assure that the tools that will be employed in the clinical studies meet the specific requirements of the end-users and the characteristics of the clinical settings where the clinical studies will be conducted. Based on the obtained feedback, refinements of the technical solution will take place during this testing phase, as well as the necessary preparations and training for conducting the clinical studies.

Phase C: Clinical Studies of the MyPal Intervention

Following the technical implementation of MyPal ePRO components and tools, this phase will implement the proposed intervention as a multi-centric RCT for adults, namely, MyPal-ADULT, and as an observational study for children, called MyPal-CHILD, in the six medical sites participating in the project. In particular, MyPal-ADULT will be conducted in four European countries, namely, Czech Republic, Greece, Italy and Sweden, and its focus will be on Chronic Lymphocytic Leukemia (CLL) and Myelodysplastic Syndromes (MDS). The medical sites have been selected, in order to accommodate the heterogeneity of the population, the different practices employed in each healthcare delivery setting, the required expertise for conducting the clinical studies, as well as an adequate number of participants. The studies will be conducted for a 21-month period, followed by the impact assessment phase, in which adaptations of the tools will be also conducted.

Phase D: Impact Assessment of the MyPal Intervention

This phase will define and implement the impact assessment strategy of the MyPal intervention. Based on the conducted studies, the impact assessment strategy will elaborate on the following aspects:

(a) Intervention effectiveness: This includes improved symptom assessment, reduced symptom burden and suffering and improved self-fulfillment, improved well-being and more active participation in disease management for patients in need of palliative care, improved support and communication between patients and their formal and informal caregivers, as well as improved access to care services.

(b) Intervention cost-effectiveness: For the economic evaluation, cost-utility analysis (CUA) will be employed. This will be based on the comparative measurements (and change over time) of health-related quality of life as well as costs for the intervention vs. non-intervention cohorts. In this light, HRQoL measures which are multidimensional and, thus, capture all aspects of patients’ well-being are of great importance in order to demonstrate the efficiency of the intervention. In relation to costs, the third-party payer perspective will be adopted. During the intervention, documentation of the resource use (admissions, visits, interventions) for each patient group will be recorded in order to estimate of costs. The cost for the third-party payer in terms of acquiring and/or maintaining the use of the intervention (application) for each patient will be added – even if it is an estimate or an indicative figure that will be tested through sensitivity analysis.