Aims
Recruitment to palliative care (PC) clinical trials is challenging due to poor performance status, competing priorities and attrition. This risks the quality of evidence underpinning PC since participating subjects may be less representative, with those who are older, more unwell and largely confined to home not included. This paper describes the emerging role of decentralised clinical trials - where some/ all trial-related activities occur outside traditional trial sites - in palliative care as presented through the exemplar of acupuncture at home clinical trial. DCT trial design was tailored to enable delivery at home, the success of which highlights the importance of novel trial delivery to ensure equitable access for, and representation of, PC patients.
Methods
The phase 2 acupuncture for cancer pain trial was offered to participants delivered in hospital (wellness centre) or at home based on participant preference. Primary outcomes included feasibility of recruitment and completion, while secondary outcomes included pain relief, impact on quality of life and analgesia use. Qualitative data on experience of trial participation were also collected.
Results
Primary outcomes of feasibility and completion were readily met with all 14 participants recruited and completing the trial within 6 months. Notably all participants requested for delivery of acupuncture at home. Qualitative data strongly endorsed the trial conduct at home ““it was so convenient to have (the acupuncturist) visit me at home…I couldn’t have done (the trial) otherwise”.
Conclusion
The easy recruitment, completion and high engagement with this trial highlights the possibilities of decentralised clinical trials. Such decentralisation of trials with majority/full delivery at home raises opportunities to improve recruitment, completion and representation of the real-world population and therefore, better evidence underpinning care. Further discussion is needed to delineate resource implications and if there are limits on which PC trials can be conducted at home.