Project FURTHER consists of workpackages, each with a different task. Together they will provide information about the (cost-)effectivenes and efficacy of the treatment, the value of an integrated pain management pathway and the factors that will influence the implementation of MR-HIFU treatment in Europe.
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Project FURTHER aims to demonstrate that MR-HIFU is an effective and cost-effective alternative or additional standard treatment option for patients with painful bone metastases, providing fast and long lasting pain relief. FURTHER also addresses scientific and socio-economic barriers that currently limit widespread adoption of MR-HIFU in order to raise awareness, and acceptance of MR-HIFU and promote its uptake into medical guidelines for palliative treatment of cancer induced bone pain.
On this webpage, you’ll read more about what the different research topics within project FURTHER.
Work package 2 is a prospective, multicenter, three-arm randomized controlled trial, performed at eight consortium institutes. In this FURTHER-trial, a total of 216 patients with painful bone metastases will be randomized to receive EBRT only, EBRT followed by MR-HIFU within a short timeframe, or MR-HIFU only. The primary outcome of the trial will be pain response at 14 days after completion of treatment. Secondary outcomes include pain response at 14 days after inclusion, and evaluation of quality of life, toxicity, adverse events and survival in the first 6 months after treatment.
Work package 3 is focused on the socio-economic factors that will influence the uptake of the tested intervention. An important factor is the cost-effectiveness of the intervention compared to standard care, but other socio-economic factors might also influence the ultimate uptake into standard practise. To create commitment and demand amongst important stakeholder groups on a national level, the consortium will invite stakeholders to actively participate in the project through local observer groups. These groups will not only observe the testing of the intervention, but will also actively map and discuss socio-economic factors that might hinder further uptake of the intervention outside of a research setting using their unique expertise and points of view.
Work package 4 aims to develop and test an integrated care pathway, aimed at optimising the pain outcomes for patients receiving either radiotherapy or MR-HIFU treatment for cancer induced bone pain. This pathway effectively ‘prehabilitates’ participants for their HIFU treatment by comprehensively addressing all facets of the bio-psycho-social construct of their pain state and ensure effective post-sonication rehabilitation. Patient reported outcome measures such as pain, quality of life, anxiety, depression, wellbeing and global recovery scores will be collected pre and post treatment and compared between the two limbs of the study to determine the effectiveness (both clinical and economic) of such a pathway. By introducing and testing this comprehensive multidisciplinary approach to more fully integrating HIFU into the treatment pathway of patients, HIFU for cancer pain will become more aligned to the standard approaches taken when selecting, preparing and managing patients receiving other complex pain interventions.
Work package 5 is focussed on the implementation of the new intervention throughout Europe. This will include mapping of European and/or worldwide stakeholders, the organization of preparatory meetings and a consensus meeting during the project and developing a white paper on the conclusions of the concensus meeting. These meetings will discuss the opportunities and pitfalls of the intervention, in order to tackle national and international hurdles now limiting utilization of the intervention. Input for these meetings will come from the 3-armed randomized clinical trial, the cost-effectiveness analysis and the pilot study for the pain management pathway. The whitepaper will include the required (modification to existing) guidelines to ensure European-wide implementation. The white paper will be published and shared among the wider network of all partners and involved stakeholders.
