Δημοσιεύσεις
Δημοσιεύσεις
Scarf`o, Lydia; Karamanidou, Christina; Doubek, Michael; Garani-Papadatos, Tina; Didi, Jana; Pontikoglou, Charalampos; Ling, Julie; Payne, Cathy; Papadaki, Helen $A$; Rosenquist, Richard; Stavroyianni, Niki; Payne, Sheila; Ghia, Paolo; Natsiavas, Pantelis; Maramis, Christos; Stamatopoulos, Kostas
MyPal ADULT study protocol: a randomised clinical trial of the MyPal ePRO-based early palliative care system in adult patients with haematological malignancies Journal Article
In: BMJ Open, vol. 11, no. 11, pp. e050256, 2021.
Abstract | BibTeX | Ετικέτες: adult palliative care; health informatics; leukaemia
@article{Scarfo2021-jm,
title = {MyPal ADULT study protocol: a randomised clinical trial of
the MyPal ePRO-based early palliative care system in adult
patients with haematological malignancies},
author = {Lydia Scarf`o and Christina Karamanidou and Michael Doubek and Tina Garani-Papadatos and Jana Didi and Charalampos Pontikoglou and Julie Ling and Cathy Payne and Helen $A$ Papadaki and Richard Rosenquist and Niki Stavroyianni and Sheila Payne and Paolo Ghia and Pantelis Natsiavas and Christos Maramis and Kostas Stamatopoulos},
year = {2021},
date = {2021-11-01},
journal = {BMJ Open},
volume = {11},
number = {11},
pages = {e050256},
abstract = {INTRODUCTION: The 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 ANALYSIS: In 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 DISSEMINATION: The 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 NUMBER: NCT04370457.},
keywords = {adult palliative care; health informatics; leukaemia},
pubstate = {published},
tppubtype = {article}
}