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Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients with Bone Metastasis

Periodic Reporting for period 1 - FURTHER (Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients with Bone Metastasis)

Reporting period: 2019-01-01 to 2020-06-30

Sixty-five percent of patients with advanced cancer develop bone metastases, with pain as a common and devastating consequence. Metastatic bone pain strongly interferes with quality of life and daily functioning of patients and their families. It affects mobility, productivity and independence, thereby creating an extra burden for informal carers including family and friends. Current standard local treatment of metastatic bone disease consists of external beam radiotherapy, which is effective in only 65% of patients.
The FURTHER project sets out to demonstrate that Magnetic Resonance Guided High Intensity Focused Ultrasound (MR-HIFU), is an effective and cost-effective alternative or additional standard treatment option for patients with painful bone metastases, providing faster 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.

Specific objectives of FURTHER
In order to reach this main aim, the FURTHER consortium sets out to:
• Generate Level I evidence to demonstrate that short-term pain relief is superior in treatment regimens with MR-HIFU (alone or in combination with External Beam Radiation Therapy ) as compared to standard-of-care treatment with External Beam Radiation Therapy (EBRT). A multicentre randomized controlled trial is designed to compare outcomes of EBRT, MR-HIFU in combination with EBRT, and MR-HIFU alone, for palliation in patients that present with painful bone metastases. Primary outcome of the trial will be pain at 14 days after randomization (WP1, 2, 3).
• Develop a prediction model that can be used to identify patients who are likely to benefit from MR-HIFU or radiotherapy in order to contribute to the (cost-) effective use of the treatment (WP2, 3).
• Investigate the added value of integrating MR-HIFU into a comprehensive pain management pathway that does not only focus on the pathophysiological component of pain but also takes into account psychophysical aspects of pain. A pilot study will be performed, in which standard EBRT and MR-HIFU treatment is compared to EBRT or MR-HIFU treatment incorporated in a comprehensive pain management pathway. By doing so, we can determine whether MR-HIFU should be presented to the patient as a single modality treatment or as part of a comprehensive pain management pathway (WP3, 4).
• Determine the cost-effectiveness of pain palliation using approaches based on MR-HIFU and EBRT. In both clinical studies, we will collect Patient Reported Outcomes as well as qualitative and quantitative data on the impact of treatment on the social context of the patient, such as partners and care-giving relatives. Combined with cost data, of the MR-HIFU treatment, but also of the comprehensive pain management strategy, this will allow us to study the relation between cost and changes in quality of life compared to reference treatment using EBRT (WP 2, 3, 4).
• Identify strategies for the adoption of MR-HIFU into standard care, mapping and analysing
socio-economic factors that influence uptake and access to MR-HIFU treatment (WP3, 5).
• Raise awareness and acceptance of MR-HIFU as a treatment option for pain palliation amongst patients, care professionals and informal carers (WP6).
Work performed and main results achieved, exploitation and dissemination

Protocols for the two Randomized Controlled Trials (Further trial and Pathway trial) to be conducted in the FURTHER project have been finalized. Ethical approval for the Randomized Controlled Trial 1 (RCT1) in the Netherlands and Italy have been obtained; the protocol is under submission in other countries. Ethical approval in the UK is on halt due to the current pandemic
Preliminary data for the FURTHER trial have been generated, database has been generated, all necessary trial questionnaires and patient questionnaires have been developed and translated.
A technical MR-HIFU expert has visited all the partner institutions to address differences between local logistics and approaches. This information has been used to optimize the MR-HIFU workflow for the trial.
Trial monitors have (virtually) visited the partner institutions for initiation visits. Due to Sars-COVID-19, no patients have been enrolled in the trial yet.

Preparations for the cost effectiveness studies have been completed: A literature review has been performed, observer groups have been identified, and partner institutions have been visited to identify parameters (of the pain management pathways) of the cost effectiveness analyses.

A pan European Survey across all partner institutions has been conducted to barriers to deployment of anaesthetic services for the MR-HIFU treatment. This survey was conducted among clinical and patient stakeholders. Outcomes were used to develop of integrated pain pathway following evidence synthesis exercise.

A project website has been launched, and a communication plan has been finalized. Several abstracts have been published and presented, first manuscript is in preparation. A press release will be launched at enrolment of the first patient.
Two consortium meetings were held (Kick-off in the Netherlands, consortium meeting in Italy)
With this project, we aim to improve management strategies of patients with painful bone metastases, by adding MR-HIFU to the standard arsenal of treatment options.

For the first time, we have combined MR-HIFU with EBRT, optimized the treatment and demonstrated that it is a feasible and safe option for local treatment of patients with painful metastatic bone disease.

In addition, with ethical approval from the majority of institutions, we are all set to start generating evidence of (potential) superiority of MR-HIFU over standard EBRT. This will help us determine whether, and for whom, this treatment option will be of benefit. Ultimately, the growing, vulnerable population of patients with painful bone metastases, will benefit from this knowledge in terms of better and faster pain control and improved quality of life.

We have compiled a group of stakeholders, who will work together to get MR-HIFU (when proven effective) accepted among patients, doctors, policy makers and insurers.
By paving the way for more effective treatment for painful bone metastases in Europe, the growing population of patients with bone metastases will be managed more effectively. There will be a reduction in doctors visit, re-treatment, and burden on family members and informal care givers.
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