MyPal ADULT study protocol: a randomised clinical trial of the MyPal ePRO-based early palliative care system in adult patients with haematological malignancies

Abstract

IntroductionThe systematic collection of electronic patient-reported outcome (ePRO) in the routine care of patients with chronic haematological malignancies such as chronic lymphocytic leukaemia (CLL) and myelodysplasia syndromes (MDS) can constitute a very ambitious but worthwhile challenge. MyPal is a Horizon 2020 Research & Innovation Action aiming to meet this challenge and foster palliative care for patients with CLL or MDS by leveraging ePRO systems to adapt to the personal needs of patients and caregiver(s).Methods and analysisIn this interventional randomised trial, 300 patients with CLL or MDS will be recruited across Europe. Patients will be randomly allocated to early palliative care using the MyPal system (n=150) versus standard care including general palliative care if needed (n=150). Patients in the experimental arm will be given access to the MyPal digital health platform which consists of purposely designed software available on smartphones and/or tablets. The platform entails different functionalities including physical and psychoemotional symptom reporting via regular questionnaire completion, spontaneous self-reporting, motivational messages, medication management and a personalised search engine for health information. Data on patients’ activity (daily steps and sleep quality) will be automatically collected via wearable devices.Ethics and disseminationThe integration of ePROs via mobile applications has raised ethical concerns regarding inclusion criteria, information provided to participants, free and voluntary consent, and respect for their autonomy. These have been carefully addressed by a multidisciplinary team. Data processing, dissemination and exploitation of the study findings will take place in full compliance with European Union data protection law. A participatory design was adopted in the development of the digital platform involving focus groups and discussions with patients to identify needs and preferences. The protocol was approved by the ethics committees of San Raffaele (8/2020), Thessaloniki ‘George Papanikolaou’ Hospital (849), Karolinska Institutet (20.10.2020), University General Hospital of Heraklion (07/15.4.2020) and University of Brno (01-120220/EK).Trial registration numberNCT04370457.

Applying Digital Health in Cancer and Palliative Care in Europe: Policy Recommendations from an International Expert Workshop (MyPal Project)

“…Ethics: This work forms part of the MyPal project (child study -ClinicalTrials.gov Identifier: NCT04381221, May 8, 2020; adult study -ClinicalTrials.gov Identifier: NCT04370457, May 1, 2020) although specific approval for the workshop was not required 9,11 . At the workshop, participants signed a written informed consent form, indicating that they were aware that discussion data would be published.…”

“…The MyPal project, involving a large European consortium, aimed to develop and test electronic patient-reported outcome systems for adults with hematological cancers and children and young people with hematological cancers or solid tumors 8 . MyPal developed a mobile application for adults to self-report physical and psychological concerns, coupled with electronic movement sensing through smartphones, tested in a randomized control trial in four countries (Czech Republic, Greece, Italy and Sweden) 9,10 . A gamification approach was employed for children and young people to self-report physical and psychological concerns through smartphones and portable devices, evaluated in a prospective observational feasibility cohort study conducted in Germany and the Czech Republic 11,12 .…”

Emotion Regulation Flexibility and Electronic Patient-Reported Outcomes: A Framework for Understanding Symptoms and Affect Dynamics in Pediatric Psycho-Oncology

“…The benefits of ePRO lie in the ecological validity of this type of approach. Furthermore, ePRO-based protocols, such as those from the MyPal-Adult [ 81 ] and MyPal4Kids [ 28 ] studies, can incorporate passive data sampling in form of integrated app functions, such as pedometers or heart rate monitoring via Wearables. This data collection technique and research methodology is also known as telemonitoring and often finds application in neighboring medical fields, such as cardiology or sports medicine.…”

Current status and future outlooks on therapeutic drug monitoring of fluorouracil

“…Nevertheless, it should be aimed towards a more frequent grading of symptom burden. By combining such a pharmacometric framework with a recommended weekly grading [208] which can now be conveniently performed with electronic questionnaires [56,209,210], the potential of continuous-time Markov models can be vastly increased in the future.…”