Professor Tina Garani-Papadatos (Greece), Professor Sheila Payne and Dr Sean Hughes (UK) on behalf of the MyPal Consortium.
Palliative care research always raises important and sensitive ethical questions.1 This is especially so when children, their parents and adults with advanced cancers are involved.
Funded by the European Commission, the MyPal research project aims to assess a patient-centred service for palliative care by improving electronic patient-reported outcome (ePRO) systems. Measurements are based on patient-reported information (eg symptoms, pain, psychological distress).
The project includes two studies: the first, MyPal4Kids, aims at creating a gamification app suitable for children with haematological cancers or solid tumours, and their parents, to regularly report their physical status and updates on their wellbeing and support received. The second study, MyPalAdult, aims to evaluate whether the MyPal mobile ePRO app can lead to improved quality of life and patient satisfaction for adults with haematological cancers, compared to standard care. Both studies fully comply with European Union rules on consent and General Data Protection Regulations; data collected will be stored securely and accessed in a way that will ensure privacy of participants. We focus now on the ethical issues for three groups of participants.
Children with cancer and their parents
We have been particularly careful in designing an approach both suitable and friendly for the child participants. Not only do we want to better motivate and help them to be as active as possible, but also to take account of the context in which they live. In the design phase of the gamified application, different levels of physical functioning were taken into consideration in relation to the health status of the child and the aims of the game. The latter requires familiarisation with the stage of disease and control of potential disappointment when a child does not perform well in the game because of advancing illness. Ethically, this addresses the need not to overburden research participants or potentially elicit harm especially, perhaps, where young people are involved. Ensuring the acceptability of digital health technologies for parents and family members providing care is essential in engaging them in the research process.2 However, special attention during this engagement process, was paid to the rights of the participating children: three different age-adjusted information sheets and assent/consent forms were prepared for children between six to nine years, 10-15 years and adolescents 16-18 years, using language which takes full consideration of their respective developmental levels. The common ethical denominator behind all these has been enabling the children’s voice to be clearly and honestly heard as most communication has been usually directed to parents..
Adults with haematological cancers
The MyPal RCT aims to test whether an app can help adults better understand and accurately report their symptoms more effectively and promptly as delays in symptom management may seriously impair the patient’s condition. It also raises ethical questions about the proper use of digital technology where there is a balance to be struck between privacy, intrusion and medical surveillance. In developing the app, we had numerous discussions and refinements, for example, agreeing inclusion and exclusion criteria to ensure that participation in the intervention group would not jeopardise access to clinical services. Moreover, notions about fitness to participate and ability to understand were addressed in a fair manner avoiding any possible discrimination for patients. We also endeavoured not to over-burden participants with too many questionnaires and assessments and will inform them in a timely manner of any new information that might influence their participation.
Health Care Professionals (HCP)
As the use of new technologies may affect the patient-professional relationship,3 a first challenge was to facilitate good communication and enhanced interaction between HCPs and patients. This aims for a shift from passive patient reporting based on conventional PRO approaches, to active patient engagement and appropriate responses from healthcare providers based on the principles of shared decision making tailored to individual patient needs. A number of ethical factors were considered in relation to this as we strive for full respect to the autonomy and privacy of all parties involved. Moreover, the studies were designed in a way that the new app interventions investigated would act in a complementary way to standard care so that the HCP focus would not divert their attention from the patient in front of them to the data generated on screen. Information from the participating clinical sites on current care provision and feedback from user groups was collected in order to contribute to the implementation design.
These, along with other ethical concerns, were built into the MyPal design to address the sensitivity of the research context and may be of relevance to others developing similar studies of new technology in cancer palliative care contexts.
- Preston N, van Delden JJM, Ingravallo F, Hughes S, Hasselaar J, van der Heide A Van den Block, L…. Payne, S. (2020). Ethical and research governance approval across Europe: Experiences from three European palliative care studies. Palliative Medicine, 34(6), 817-821. https://doi.org/10.1177/0269216320908774
- Widberg C, Wiklund B, Klarare A. (2020) Patients’ experiences of eHealth in palliative care: an integrative review. BMC Palliat Care 19, 158. https://doi.org/10.1186/s12904-020-00667-1
- Baggott C, Baird J, Hinds P, Ruland CM, Miaskowski C: Evaluation of Sisom: A computer-based animated tool to elicit symptoms and psychosocial concerns from children with European Journal of Oncology Nursing, 19 (2015) 359e369.
More about the authors…
Prof Tina Garani-Papadatos is a lawyer and Professor of Public Health Ethics in the Department of Public Health Policy, School of Public Health, University of West Attica, Athens, Greece, and a member of MyPal Consortium.
Prof Sheila Payne holds an Emeritus Chair at the International Observatory on End of Life Care, Division of Health Research, Lancaster University, UK, and is a member of MyPal Consortium, leading work on Dissemination. She is recognised internationally for her research expertise in palliative and end-of-life care.
Dr Sean Hughes practised for many years as a specialist palliative care social worker and is now a lecturer in Palliative Care in the International Observatory on End of Life Care. Sean is also a member of MyPal Consortium.
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