Periodic Reporting for period 1 - PREFERABLE (Project on Exercise for Fatigue Eradication in Advanced Breast cancer to improve quality of life)
Reporting period: 2019-01-01 to 2020-06-30
PREFERABLE’s vision is to improve the standard of care in MBC by improving the quality, effectiveness and cost-effectiveness for patients in a palliative setting using a non-pharmacological intervention combining supervised and unsupervised app-based exercise. Based on the results from a multinational randomised controlled phase 3 clinical trial (EFFECT trial; (cost)- effectiveness study), the different perspectives of patients with MBC on exercising (PERSPECTIVE study), and through mapping the differences in the European healthcare systems, the PREFERABLE project will generate solid and conclusive evidence of the beneficial effect of exercise on cancer-related side effects and patients’ quality of life in the palliative setting. By this, PREFERABLE will contribute towards reshaping medical practice and improving clinical guidelines and recommendations.
For the EFFECT trial, general study documents and procedures have been developed in collaboration with all consortium members. A protocol for participant inclusion across all participating centres has been developed as well as participant information and informed consent package. To support the consortium in the development of the exercise intervention, an EFFECT exercise board has been installed. The web-based portal CASTOR and supporting systems for the study sites have been set up. Training materials with scientific and operational content have been developed and implemented in collaboration with the consortium.All questionnaires as well as all outcomes and factors that are to be assessed and recorded in the EFFECT-Study were compiled in the Outcome Assessment Package. A statistical analysis plan (SAP) was developed before any outcome data of the EFFECT trial was assessed to yield high-quality, valid and reproducible study results. Furthermore, the exercise app for unsupervised training was designed and developed. It includes resistance and endurance exercises, instructions of the exercises as well as safety instructions. The first patient was enrolled the 8th of January in the UMC Utrecht. Up to now, 11 patients have been enrolled in the The Netherlands, 4 in Germany, 5 in Spain and 6 in Sweden. The supervised exercise sessions are offered at various community or hospital-based fitness centers, physical therapy practices, gyms or personal training facilities throughout the catchment areas of the recruiting sites and close to the patients’ homes. Due to COVID-19, it has been no longer considered safe to offer exercise sessions at physical therapy practices. In order to continue the exercise program for patients who already started, the exercise training was facilitated at home. From June 2020 on, most centers re-started.
For the PERSPECTIVE study, the survey was finalized in all languages and has been made electronically available as well as in paper and pencil versions. So far, 74 out of 500 participants have been recruited: 31 in Spain, 31 in Germany, 5 in The Netherlands,
effectiveness of the exercise intervention in reducing the most common and burdensome side-effect, i.e. cancer-related fatigue (first primary endpoint), and/or improving health-related QoL (second primary endpoint) in the palliative setting.