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PREFERABLE-II - Personalised Exercise-Oncology for improvement of supportive care: a super umbrella trial to demonstrate the (cost)effectiveness of live-remote exercise in cancer survivors

Periodic Reporting for period 1 - PREFERABLE-II (PREFERABLE-II - Personalised Exercise-Oncology for improvement of supportive care: a super umbrella trial to demonstrate the (cost)effectiveness of live-remote exercise in cancer survivors)

Reporting period: 2022-11-01 to 2024-04-30

With over 12 million cancer survivors relying on supportive care across the EU, it is essential to provide them with (cost-)effective interventions tailored to their specific needs. Many survivors suffer from long-term side effects that can lower their quality of life (QoL), functioning, and productivity. Exercise interventions have proven to be uniquely beneficial in managing both physical and psychological complaints. However, their effects are strongest when tailored to a patient's specific burden, e.g. fatigue, low physical fitness, anxiety and depressive symptoms or chemotherapy-induced peripheral neuropathy. Moreover, the use of exercise interventions in supportive cancer care is still limited due to a lack of availability, a lack of accessibility caused by time and travel constraints and low awareness. To tackle these hurdles, the PREFERABLE-II consortium sets out to design and demonstrate the (cost-)effectiveness of a novel exercise intervention that:

1) will be tailored to the side effect that bothers the survivor the most, by use of a modular design,
2) can be implemented at home, with live-remote supervision from a national broadcast centre,
3) is available to all cancer survivors who keep having complaints after their chemotherapy treatment, and
4) incorporates improved patient-centred communication and shared decision making.

Results of our RCT, enrolling 352 cancer survivors, will be translated into guideline recommendations for exercise-oncology. Extensive ethical, legal and social impact components of the project will reveal barriers and facilitators of live-remote supervised exercise and provide policy recommendations to further support implementation. Finally, we will create communication standards and an education module for healthcare professionals to train the future workforce. As such, PREFERABLE-II contributes to improving the quality of life of cancer survivors by lowering the burden of side effects, while also improving availability, accessibility and awareness off exercise-based supportive care interventions.
In the beginning of the project, we presented the background and our plans of the project at the EU Parliament with the aim to make the need and potential visible. In addition, members of PREFERABLE-II are also involved in Horizon Europe Quality of Life Cluster for Cancer Mission projects and Horizon Europe health projects to combine the efforts for a healthy Europe.

With regard to our core activities, we have performed the following work in the first 1.5 years of the project:
- Completed the design and preparation for the multinational LION-RCT trial, including the setup of the different programs for live-remote exercise, as well as the outcome measures, implementation of the technology to be used, and we completed the educational materials for the trainers and participants,
- Prepared the questionnaires to collect data for the analysis on economic aspects,
- Obtained central ethical approval and local approval for most sites, and the first participants were included,
- Further and systematically elaborated that there is currently little literature available on the legal aspects of remote rehabilitation, and write a manuscript with ethical reflections and a call to action for the scientific and clinical community to develop these aspects of telerehabilitation,
- Held the first focus groups and developed surveys to gain more understanding on social and legal aspects, and
- Prepared focus groups to understand what types of communication will be most effective when implementing live-remote supervised exercise.
During the first period the focus has been on setting up the various activities and initiating their execution.
(Part of) The PREFERABLE-II consortium to present the project in the EU Parliament.
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