PROACT (Patient Reported Outcomes About Clinical Tolerability) is a system that gives patients and caregivers a way to compliantly share their experiences on trial with their research team. Participants have control over what they want to share in video, audio, or text messages, and when they would like to share them. This PROACT trial, one of the first Technology Clinical Trials that we conducted, aimed to understand the implications of setting up and using the PROACT system in multiple early phase studies, at multiple sites. It aimed to address “what impact does the experimental medicine and early clinical trial have on peoples’ daily lives? And what are the benefits and burdens from a patient’s perspective?” and also aimed to characterise how patients used the system, and to also understand whether it is practical to give PROACT accounts to primary caregivers.
Research nurses played a key role in responding to messages and arranging care. In addition, nurses identified several benefits, most of which related to providing timely support as well as signposting to external guidance when needed. Clinical trial participants shared a wide range of experiences, from tolerability, information about the drug or schedule, benefits of the drug, logistics, or to simply say ‘thank you’. All of these delivered a rich understanding of patient and carer perspectives, context around the reported data, impacts that the drug and trial were having, and coping strategies that were being used. Critically, this approach was also an efficient method for capturing the emotional status of participants through their own words and also selection of emoticons.
In conclusion, use of communications systems such as PROACT can provide researchers with an early glimpse into patient and carer experiences that could affect adherence and decisions around compliance in the future. As virtual trials become a reality, and participants have less face-to-face interaction with their medical team, these early insights are likely to become increasingly important. A researcher being able to hear directly from trial participants about which factors of a study and drug are burdensome, coping strategies, and what is driving emotional decisions, may make an essential difference in the quest to develop medicines that work both clinically, and for the people they’re intended to treat.
“PROACT allows patients to keep in touch with their study team in between their visits to clinic. This gives us updates on how patients are coping with any side effects and we are able to provide them with better support” – ECMT Clinical Research Nurse