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

Projektinformationen

PREFERABLE-II

ID Finanzhilfevereinbarung: 101057059

DOI

10.3030/101057059

EK-Unterschriftsdatum 24 Mai 2022

Startdatum 1 November 2022

Enddatum 31 Oktober 2027

Finanziert unter

• Health

Gesamtkosten

€ 6 011 451,25

EU-Beitrag

€ 5 925 462,50

Koordiniert durch

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands

Periodic Reporting for period 2 - 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)

Berichtszeitraum: 2024-05-01 bis 2025-10-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

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 QoL of cancer survivors by lowering the burden of side effects, while also improving availability, accessibility and awareness of exercise-based supportive care interventions.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

In the beginning of the project, we presented the background and our plans of the project at the EU Parliament with the aim of highlighting the need and potential of the project. In addition, members of PREFERABLE-II are also involved in Horizon Europe Quality of Life – Patient Centered Care Cluster (QoL-PCC) for Cancer Mission projects and Horizon Europe health projects to combine the efforts for driving meaningful progress toward a cohesive and effective approach to patient centered care in cancer care.
With regard to our core activities, we have performed the following work in the first 3 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.
- Inclusion of participants in our LION-RCT trial. This work is ongoing: we currently have over two hundred participants included.
- Prepared the questionnaires to collect data for the analysis on economic aspects.
- Wrote a manuscript on the legal aspects of remote rehabilitation with ethical reflections and a call to action for the scientific and clinical community to develop these aspects of telerehabilitation.
- Created a checklist of identified legal issues to support the safe and efficient delivery of the program for health care professionals.
- Held focus groups and developed surveys to gain more understanding on social and legal aspects.
- Held focus groups and developed surveys to understand what types of communication will be most effective when implementing live-remote supervised exercise.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

During the first two periods, the focus has been on setting up the various activities and initiating their execution and performing the studies.

(Part of) The PREFERABLE-II consortium to present the project in the EU Parliament.