Concept
For MyPal, palliative care is considered as appropriate at any age and at any stage in a serious illness, regardless of the eventual outcome, and can be provided along with curative treatment. Thus, it concerns patients who require complex treatment, experience symptom burden and Quality of Life (QoL) deficits, while facing prognostic uncertainty or poor prognosis. Evidence suggests that early integration of palliative care can improve both patient and caregiver outcomes.
Several landmark randomised controlled trials (RCTs) of palliative-care interventions in patients with advanced-stage cancer have used patient-reported outcome (PRO) based endpoints to assess clinical benefit. Overall, the use of PROs has become a prominent topic in healthcare innovation, highlighting the role of the patient experience as a key measure of healthcare quality. PRO recording enables direct measurement of the experiences of patients; thus, PROs they constitute a critical element of person-centred, high-quality care for patients with cancer.
A growing body of literature supports the feasibility of electronic collection of PROs (ePROs), yielding reliable data that are sometimes of better quality than clinician-reported data. Empowering patients to provide data (either explicitly or implicitly through appropriate technologies or their family and informal carers) regarding their health condition, can provide further insights on treatment response, disease evolution, QoL and disease burden, as well as behavioural aspects.
MyPal introduces a digital health, personalized (MyPal) intervention for palliative cancer care exploiting the value of advanced ePROs. The targeted users of the intervention are adults (with hematologic cancers) and children (with hematologic cancers or solid tumors) as well as their families and healthcare providers. MyPal will assess the effectiveness and cost-effectiveness of its intervention by conducting two clinical studies, conducted in 6 clinical sites across 5 European countries. In particular, MyPal-ADULT will be a randomized controlled trial (RCT) for chronic lymphocytic leukemia (CLL) and myelodysplastic syndrome (MDS) patients, conducted in FN BRNO (Czech Republic), KI (Sweden), PAGNI (Greece), USR (Italy), and MyPal-CHILD will be a non-interventional, observational study, conducted in FN BRNO (Czech Republic), MHH (Germany) and USAAR (Germany). The main challenge for MyPal-ADULT is to address digital and health literacy, while for MyPal-CHILD a “gamification” approach will be employed for reporting by children.