Dr Lydia Scarfò, Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele
One year and eleven months after the project kick-off in a sunny Thessaloniki in January 2019, we enrolled our first patient in the MyPAL Adult study. The MyPAL Adult study is designed as a randomized clinical trial of patients diagnosed with chronic lymphocytic leukaemia (CLL) or myelodysplastic syndrome (MDS) who are currently receiving treatment or have been previously treated for their haematological malignancies. Patients are randomized with the same probability (1:1 ratio) to the intervention arm, where they are invited to actively use the MyPAL app, or the standard care (control) arm, where they are managed according to the best supportive care without any access to the app. The app includes different functionalities including quality of life questionnaires, symptom reporting, medication reminders, motivational messages, and a search engine with reliable resources selected by the treating physicians. The study aims to demonstrate that the regular use of the MyPAL app provides a benefit in terms of quality of life and use of health resources as documented by EORTC QLQ-30 and EQ5D scores.
Although the study design appears straightforward, many challenges were faced by the clinical and technical teams before the trial could start. This was made much more difficult by the COVID-19 pandemic. First, we needed to fulfil regulatory requirements, as our priority was to safeguard patient data. General Data Protection Regulations (GDPR) are designed to protect persons with regard to the processing of personal data and on the free movement of such data, and was implemented in the European Union starting from May 25th, 2018. As GDPR requirements were applied differently in different countries, each participating site has integrated them in a distinctive way in its information technology (IT) design and the MyPAL platform and app needed to be adapted and integrated in the existing structures.
This required continuous interactions between the technical partners (CERTH, FORTH, Fraunhofer) and local IT departments to implement platform updates. Clinical users were actively testing the platform to identify ‘bugs’ and translation errors and worked hard towards the goal of optimizing the app before its use by the trial patients. In the rehearsal testing, study personnel, their relatives and friends became ‘fake’ patients and provided relevant insights on how improve the usability of the app. Every site was trained on the use of the platform by the CERTH technical team, and that made it easy to understand how to navigate different pages and functions in order to gain full access to patient related information and feedback.
In parallel, we completed the regulatory path and obtained ethical and governance approval at each participating site, a necessary step to start enrolling patients into the trial.CERTH and FORTH developed and implemented a randomization algorithm and integrated it in the platform.
Needless to say, just before the recruitment start, technical and clinical partners had to struggle with the hurdles related to the COVID-19 pandemic. CERTH as Sponsor of the study, conducted a survey to understand the impact of COVID-19 on the possibility of performing the clinical trial as designed in the protocol. The study design planned monthly visits on-site for both the intervention and the standard arm for the first 6 months and this was considered a potential issue to be discussed in view of the restrictions applied to prevent COVID-19 spread. In this regard participating sites reported that with restricted access to the hospitals, enrolment into the trial would be biased to include patients on active treatment compared to those in follow-up after at least one line of therapy, as they were still coming to the sites to receive treatment and have their blood tests done. That was considered an acceptable trade-off, especially considering that these patients are the ones expected to benefit most from the use of the app.
In January 2021, 4 out 5 sites started recruiting patients, including the University Hospital of Brno in Czech Republic, PAGNI in Crete, Papanikolau Hospital in Thessaloniki, Greece and San Raffaele Hospital in Milan, Italy. The first patient enrolled in the study was in PAGNI and was randomized to the intervention arm. As of 8th April 2021, 33 patients have been enrolled: 15 in Brno, 7 in Thessaloniki, 7 in Milan and 4 in Crete. We are looking forward to reaching our goal of 300 patients (150 randomized to the intervention arm and 150 to the standard arm) in the next 10-months, although only time will tell if this is possible.