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

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MyPal ADULT study protocol: A randomised clinical trial of the MyPal ePRO-based early palliative care system in adult patients with haematological malignancies. / Scarfò, L.; Karamanidou, C.; Doubek, M. et al.
In: BMJ Open, Vol. 11, No. 11, e050256, 02.11.2021.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Harvard

Scarfò, L, Karamanidou, C, Doubek, M, Garani-Papadatos, T, Didi, J, Pontikoglou, C, Ling, J, Payne, C, Papadaki, HA, Rosenquist, R, Stavroyianni, N, Payne, S, Ghia, P, Natsiavas, P, Maramis, C & Stamatopoulos, K 2021, 'MyPal ADULT study protocol: A randomised clinical trial of the MyPal ePRO-based early palliative care system in adult patients with haematological malignancies', BMJ Open, vol. 11, no. 11, e050256. https://doi.org/10.1136/bmjopen-2021-050256

APA

Scarfò, L., Karamanidou, C., Doubek, M., Garani-Papadatos, T., Didi, J., Pontikoglou, C., Ling, J., Payne, C., Papadaki, H. A., Rosenquist, R., Stavroyianni, N., Payne, S., Ghia, P., Natsiavas, P., Maramis, C., & Stamatopoulos, K. (2021). MyPal ADULT study protocol: A randomised clinical trial of the MyPal ePRO-based early palliative care system in adult patients with haematological malignancies. BMJ Open, 11(11), Article e050256. https://doi.org/10.1136/bmjopen-2021-050256

Vancouver

Scarfò L, Karamanidou C, Doubek M, Garani-Papadatos T, Didi J, Pontikoglou C et al. MyPal ADULT study protocol: A randomised clinical trial of the MyPal ePRO-based early palliative care system in adult patients with haematological malignancies. BMJ Open. 2021 Nov 2;11(11):e050256. doi: 10.1136/bmjopen-2021-050256

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Bibtex

@article{dc73aeb967c942ddafb8fb898b20b7c3,
title = "MyPal ADULT study protocol: A randomised clinical trial of the MyPal ePRO-based early palliative care system in adult patients with haematological malignancies",
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. {\textcopyright}",
keywords = "adult palliative care, health informatics, leukaemia, Article, cancer palliative therapy, cancer patient, caregiver, chronic lymphatic leukemia, clinical protocol, controlled study, European Union, follow up, human, major clinical study, medication therapy management, mobile application, myelodysplastic syndrome, outcome assessment, patient-reported outcome, personal needs, professional standard, randomized controlled trial, sleep quality",
author = "L. Scarf{\`o} and C. Karamanidou and M. Doubek and T. Garani-Papadatos and J. Didi and C. Pontikoglou and J. Ling and C. Payne and H.A. Papadaki and R. Rosenquist and N. Stavroyianni and S. Payne and P. Ghia and P. Natsiavas and C. Maramis and K. Stamatopoulos",
year = "2021",
month = nov,
day = "2",
doi = "10.1136/bmjopen-2021-050256",
language = "English",
volume = "11",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group Ltd",
number = "11",

}

RIS

TY - JOUR

T1 - MyPal ADULT study protocol

T2 - A randomised clinical trial of the MyPal ePRO-based early palliative care system in adult patients with haematological malignancies

AU - Scarfò, L.

AU - Karamanidou, C.

AU - Doubek, M.

AU - Garani-Papadatos, T.

AU - Didi, J.

AU - Pontikoglou, C.

AU - Ling, J.

AU - Payne, C.

AU - Papadaki, H.A.

AU - Rosenquist, R.

AU - Stavroyianni, N.

AU - Payne, S.

AU - Ghia, P.

AU - Natsiavas, P.

AU - Maramis, C.

AU - Stamatopoulos, K.

PY - 2021/11/2

Y1 - 2021/11/2

N2 - 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. ©

AB - 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. ©

KW - adult palliative care

KW - health informatics

KW - leukaemia

KW - Article

KW - cancer palliative therapy

KW - cancer patient

KW - caregiver

KW - chronic lymphatic leukemia

KW - clinical protocol

KW - controlled study

KW - European Union

KW - follow up

KW - human

KW - major clinical study

KW - medication therapy management

KW - mobile application

KW - myelodysplastic syndrome

KW - outcome assessment

KW - patient-reported outcome

KW - personal needs

KW - professional standard

KW - randomized controlled trial

KW - sleep quality

U2 - 10.1136/bmjopen-2021-050256

DO - 10.1136/bmjopen-2021-050256

M3 - Journal article

VL - 11

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 11

M1 - e050256

ER -