MyPal includes the following work packages:
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WP1: Ethical Framework & Drivers for Leveraging Patient Reported Outcome Systems
WP2: Intervention Design
WP3: Patient Reported Outcome Tool for Adults
WP4: Patient Reported Outcome Tool for Children
WP5: Tools for Exploiting PROs and Advancing ePRO Systems
WP6: Clinical Studies Implementation, Evaluation and Impact Assessment
WP7: Dissemination & Exploitation
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.