Cancer immunotherapy brought about significant progress in cancer treatment. It resulted in high efficacy in some cancers; e.g., up to 60% objective response rate in melanoma and 80% complete response rate in acute lymphoblastic leukaemia. Nevertheless, two main challenges still impede improving cancer patients’ health status and quality of life (QoL) after immunotherapy initiation: 1) a crucial need for “predictive markers” of occurrence of immunotherapy-related adverse events (IR-AEs) to predict and improve patients’ health status and promote their QoL; and, 2) the lack of knowledge on patients after start of immunotherapy outside randomised controlled trials. To reach these goals, significantly more diversified sources of data are required.
QUALITOP aims at developing a European immunotherapy-specific open Smart Digital Platform and using big data analysis, artificial intelligence, and simulation modelling approaches. This will enable collecting and aggregating efficiently real-world data to monitor health status and QoL of cancer patients given immunotherapy. Through causal inference analyses, QUALITOP will identify the determinants of health status regarding IR-AEs and define patient profiles in a real-world context. For this, heterogeneous data sources (big data), both retrospective and prospective –collected for QUALITOP from clinical centres in four EU countries—will integrate lifestyle, genetic, and psychosocial determinants of QoL. Using machine learning approaches, QUALITOP will provide “real-time” recommendations stemming from patient profiles and feedbacks via the Smart Digital Platform. Furthermore, an increased visibility on patients’ behaviour, a better IR-AEs prediction, and an improvement of care coordination will help analysing through simulation modelling approaches the gain in cost-effectiveness. Guidelines will be issued over the short and long-term.
The overall aim of project management is to plan, organize and control processes to achieve the specific objectives of QUALITOP. In particular, the objectives of this work package are:
- O1.1: To ensure smooth and efficient overall project coordination.
- O1.2: To ensure scientific, administrative, financial and legal project management.
- O1.3: To relay information between the Commission and the Consortium.
- O1.4: To ensure effective co-operation and communication among partners.
- O1.5: To ensure efficient decision-making.
- O1.6: To identify potential risks for the project and set up smooth implementation and contingency plans for risk mitigation and potential conflict resolution.
Work package 1 will be led by Hospices Civils de Lyon, under the responsibility of the Project Coordinator, supported by its affiliate company, Lyon Ingénierie Projets.
This work package will coordinate the collaborative efforts of all the clinicians involved in the project. At the project scale, WP2 will contribute to i/ improve the safety of immunotherapy given alone or in combination, especially regarding the occurrence of severe IR-AEs ii/ to better estimate the immunotherapy impact on patients and relatives life including health status, social life, professional or family life, and iii/ to implement practical guidelines or suggest regulatory changes to improve the general condition of cancer patients treated with immunotherapy. To this end, WP2 will design the collection of clinically relevant documentation and data sources and prepare all needed documents to ensure the protection of sensitive data, to obtain the IRB approvals, and to incorporate prevalent and incident cases to the project.
This work package aims:
- O3.1: To identify relevant psychosocial determinants of patients’ quality of life in a longitudinal perspective while considering social and territorial inequalities.
- O3.2: To explore health beliefs and social representations related to immunotherapy in comparison with other therapeutic options, and how they might influence more general cancer-related health beliefs and social representations.
- O3.3: To explore the possible impact of immunotherapy on patients’ empowerment and doctor-patient relationship
- O3.4: To offer a dyadic and process-oriented approach to quality of life in couples during immunotherapy
- O3.5: To explore the possible impact of polymedication, self-medication, use of phytotherapy and other products purchased on Internet on quality of life.
- O3.6: To explore how health beliefs and social representations might influence drugs exposure
This WP will develop the data management principles, technology and a Smart Digital Platform and associated Medical Data Lake that enable networked medical agencies to share and exchange trusted and secure medical data with automated and robust controls based on FAIR (Findable, Accessible, Interoperable, Reusable) principles (www.go-fair.org/fair-principles/). The Digital Platform will operate on medical data collected in WP2, such as patient, immunotherapy, clinical examination, treatment, images, etc., and WP3, such as psychosocial data, health beliefs and social representations related to immunotherapy, to convert it to smart data so that it can help make informed recommendations by employing the monitoring and data analysis tools in WP6. A key focus will be in empowering patients to manage in their own care and wellbeing. Objective is to offer Integrated Care that will create a shift from delivering “passive” health and social care services by making individuals “active” partners in managing their own health – evolving into a genuinely person-centric approach to care delivery.
The first aim of this work package is to identify common side effects experienced by patients on immunotherapy and to establish the timing of these effects following the start of treatment. The second aim is to understand what determines the occurrence of these side effects: what is the role of patients’ demographics, treatment regimens and other illnesses in the risk of developing serious side effects? The third aim is to quantify the impact of these side effects on short- and long-term quality of life. Altogether, this research will provide evidence to improve the management of patients receiving immunotherapy and their quality of life, by predicting individual risks of severe side effects.
To achieve these goals, advanced statistical tools, such as causal inference methods, machine learning and prediction modelling will be used, on a variety of data sources, including hospital-based records, primary care records, newly created datasets, and survey data specifically collected as part of QUALITOP.
The digitization of electronic health records and clinical data, wearable technologies, mobile and the IoT are contributing to the data deluge. This WP will focus on innovations in technology needed to make it possible to transform these data into meaningful and actionable insights to enhance patient care by effectively monitoring health status of individual patients, providing overall actionable insights at the point of care and improving QoL after the cancer treatment. Specifically, this WP will embed Artificial Intelligence and healthcare analytics in the Smart Medical Data Processing Platform to predict, coach, advise, alert, or schedule with minimal intervention from care managers. Combined with population analytics and genomics, technologies such as AI and analytics it will better predict healthcare risks.
This WP has two major stages: development of a simulation model, and model analysis, that is, calibrate and validate the model to the current scientific literature and data and insights provided from previous WPs to conduct policy and cost-effectiveness analyses. In the first step, we will use system dynamics to develop a qualitative causal loop diagram and ground it in the current scientific literature. The model will be refined based on the addition of psychosocial determinants of patients’ QoL found in WP3. In the model analysis stage, which will integrate the causal inference results from WP5 and insights from WP6, we will analyse the dynamics of QoL and lead to general feasibility and cost analysis.
WP8 will run in parallel with the other packages during the entire lifecycle of the project and focuses on dissemination and communication of the project’s aims, approach, results and outcomes. Dissemination of the project’s progress and outcomes is a role of all the partners. As such, WP8 will support and collaborate with all the partners to ensure information flow from the other WPs to enable information to be shared internally and externally. Its main objective is the widest possible dissemination of the project’s results to both the cancer patient and research community and all other identified stakeholders.