A cancer research team at the Freeman Hospital’s Sir Bobby Robson Cancer Trials Research Centre has been shortlisted in this year’s Nursing Times Awards.
Named as Finalists in the Clinical Research Nursing category, the team is recognised for rapidly developing and implementing the UK’s first online consenting process within early phase clinical trial research in response to the challenges presented by the COVID-19 pandemic.
Once established, the team in Newcastle collaborated with the Manchester Christie UpSMART team to further develop their work into a national online resource for other cancer research centres to access next year.
“Early phase studies are essential to ensure we can continue our search for new and more effective cancer treatments,” explains Ben Hood, Nurse Consultant for Cancer Research who led on the new initiative. “We were keen to do all that we could to minimise the impact of the pandemic on our patients, and support social distancing measures for patients coming into hospital.
“Patient involvement is key to ensuring that even the slightest modifications we make to any of our processes are safe and effective. As the first national lockdown took hold we began to look at how we could be innovative in the way we engaged with patients who would normally travel to attend our centre.”
Ben continues “To ensure a fully inclusive approach, we worked with the Newcastle Perspectives in Cancer Research Public and Patient Involvement (PPI) Group and the Health Research Authority (HRA) to develop an online method of consenting patients into clinical research”
The challenge
The national lockdown and subsequent social distancing restrictions had a major impact on all patients – in particular those who were vulnerable due to their condition and advised not to attend hospital clinics.
For some research studies at the Sir Bobby Robson Cancer Trials Research Centre, patients are required to come in to give consent for staff there to access previously taken tumour samples.
These samples allow researchers to analyse and test for genetic changes to find patients who could be eligible for large-scale clinical trials, potentially giving them access to newly developing cancer treatments.
Gaining patients’ consent to access their samples was essential to carrying on this life changing work.
“We knew that establishing a new patient friendly process of consenting patients into trials would be challenging,” says Ben. “In particular trying to introduce the use of cloud-based video conferencing services and an online electronic consent system when seeking consent for cancer clinical trials, which had never been done before in cancer research within the UK.
“Yet we knew that in some cases, the only way to be able to keep our patients safely involved in trials during the pandemic was to develop a means of engaging with them remotely.”
Experimental Cancer Medicine Centres
Newcastle is one of only 18 Experimental Cancer Medicine Centres (ECMC) in the UK offering early phase research studies to patients from all over the North East and North Cumbria with advanced cancer. The ECMCs offer patients the opportunity to discuss and potentially access early phase trials when there are no other treatment options available to them. It was vital to keep these studies open.
“We contacted the ECMC network and other organisations to enquire about guidelines for electronic consent and found there weren’t any,” continues Ben. “So we embarked on creating a new patient friendly electronic consent process ourselves and started by engaging with our PPI group members to help us shape how this would look and work.
“The group acted as our service user experts and were involved in the entire project. Giving feedback at every point of the project, from initial ideas, development, testing and development of patient instructions for using the system. Their input was invaluable.”
Members from the group have since presented their experiences from being involved in the project at national conferences and will be involved in the development of future resources around electronic consent.
Ben adds: “The whole project has been a great success and what we now know is that the real benefits for our patients in addition to improved accessibility to early phase cancer trials has been a greatly improved experience. This has included reduced or no travel time and the ability to invite family members – no matter where – to take a part in their research discussions, supporting them online.
“This, in our view, has the potential to improve the informed consent process, and from patient feedback vastly reduced the anxieties associated with making big decisions on their own.”
The impact
During the inception, development and implementation of this project the Sir Bobby Robson Cancer Trials Cancer Centre team have:
- Developed the very first method of electronic consent for cancer research following a legal, practical, patient tested methodology approved by both the Trust and Research Trial Sponsors
- Utilised a patient and public co-designed approach to ensure the patient voice was at the centre of the approach
- Developed an electronic consent process within early phase cancer research that is transferable and can be used in other clinical research areas.
- Shared learning gained including resources and new practices at national conferences to showcase the patient benefits and empower other cancer research nursing teams across the UK to embed the new approach in their own areas.
From this work a free online educational resource will be created next year, which will be available for access by all cancer research units across the UK.
The national Cancer Research UK senior nurse network will be one of the main professional drivers at the other centres across the UK to enable normalisation of these new methods of working within those cancer centres.
The winners of the Nursing Times Awards 2022 will be announced on Wednesday 26 October. We wish all our finalists the very best of luck.
