We involved patients and public at an early stage in our design and planning. A preliminary draft of our funding application was sent to the Marie Curie Expert Voices group to seek their views about the willingness of patients to participate in such a project, the appropriateness of using randomisation and of ‘blinding’. We also asked patients and service users to comment on the proposed length of the study and the perceived burden of study participation. As a result of patient feedback, we strove to keep the patient burden to a minimum. We carefully selected outcome measures to be appropriate and well-used in this population. Working with our PPI collaborators, we were mindful of making sure that patient information leaflets provided a clear description of the potential side effects of study medications. PPI representatives were supportive of the plan to include weekly telephone contact during the study. Since the start of the study, one of our original PPI representatives (Kathy Seddon) has been on the TSC. Shortly after the study began, Peter Buckle, another member of Marie Curie Expert Voices PPI panel, joined the study TMG and has attended monthly meetings ever since.
Patient and public involvement in the MePFAC study has had several important benefits. There is sometimes a misconception among RECs that involving palliative care patients in research studies may be unduly onerous or burdensome. It was helpful for the research team to be able to reassure the REC that we had consulted PPI representatives during the course of the study to ensure that (as far as possible) the proposed trial design would likely be acceptable to patients with advanced cancer. We have been very grateful for the significant time commitment of our PPI members, particularly Peter Buckle who has attended monthly TMG meeting for the duration of the study. He has been able to provide a very useful perspective on issues that arose throughout the course of the study, for example, in deciding how the research team should respond to the challenges posed by the COVID pandemic. PPI has helped to ensure that the findings from our study have been communicated clearly so that their meaning and significance for patients and the public can be clearly understood. Moreover, Peter Buckle contributed to production of training videos, study management, trial oversight, interpretation of study data and the drafting of both this report and associated conference abstracts and other peer-reviewed publications.
Peter reflected on his contribution to the trial:
By way of background, my wife Wendy died from a glioblastoma at the age of 54 less than five months after diagnosis. She suffered from no fewer than 28 symptoms, side effects and disabilities, including severe fatigue. Obviously, this was for a shorter period than many other terminally ill cancer patients because of the speed of disease progression. This was my first experience of the death of a loved one, and after the event, it became quite clear to me that her end-of-life care was poor in many respects. The year after Wendy’s death, I became a volunteer for the Marie Curie charity, and was an original member of their Research Voices group. As such, I had dealings with Professor Stone and the UCL Research group for palliative and end-of-life care and was pleased to be invited to join the TMG for this study.
It is always disappointing from a patient advocate viewpoint to find that an intervention does not show a significant benefit for patients who are suffering. However, there is value in the findings from this study despite this.
I would like to take this opportunity to make two observations. The first is to thank Professor Stone and all other TMG members for their appreciation of my experience and position, their patience when required to explain issues and their genuine and continual welcome of my input. Secondly, I must commend all involved for the innovative and professional way in which the trial was conducted during the Covid pandemic. This was most impressive.
To conclude, this study has exposed some of the difficulties that potentially arise in research into the neglected area of palliative and end-of-life care. I would like to see improvements to the support and infrastructure in this area going forward.
We have tried to highlight involvement of patients in the MePFAC study through various dissemination projects and outputs. The East Midlands NIHR produced a patient experience video about a patient who was involved in the MePFAC trial. Sandra’s Story explained the importance of patient involvement in palliative care and the role of research within a hospice. The importance of undertaking research in hospices was also showcased in an article in the Pilgrims Hospices newsletter (Pilgrims Matters) which is distributed widely to hospice supporters and members of the public in Kent. Furthermore, a case study about the positive benefits for patients participating in palliative care research (using the MePFAC trial as an exemplar) was produced by the NIHR and is available on their website (https://local.nihr.ac.uk/case-studies/grateful-mum-living-life-to-the-fullest-thanks-to-south-london-researchers/30658).