Periodic Reporting for period 2 - PREFERABLE (Project on Exercise for Fatigue Eradication in Advanced Breast cancer to improve quality of life)
Berichtszeitraum: 2020-07-01 bis 2021-12-31
Despite the tremendous improvement in early diagnosis and treatment of breast cancer, a large proportion (up to 40%) of patients with breast cancer will eventually develop metastases. Patients with metastatic breast cancer (MBC) have a median overall survival of 2-3 years, and a relative 5-year survival of 34%. Current advances in therapy have extended the life of those patients with MBC; however, these patients still suffer (for longer periods) from deleterious side-effects (either related to the disease itself or to the treatment) such as fatigue, pain, nausea and vomiting, insomnia, dyspnoea, emotional, social and cognitive dysfunction. Among all these side-effects, fatigue is the most common and distressing treatment-related side-effect, as up to 90% of patients with MBC experience fatigue over the course of treatment. All these symptoms negatively affect patients’ QoL and thus an urgent solution is needed to help those with advanced breast cancer to “live well” for as long as possible.
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.
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.
In the first reporting period, January 2019 – June 2020, the whole project management was set up. During that period, the project focused on the setup of the EFFECT clinical trial as well as the PERSPECTIVE study. The first patient for the EFFECT study was enrolled in January 2020. Then the COVID-19 pandemic started and exercise sessions at physical therapy practices was not possible. 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 recruitment.
During the second reporting period, July 2020 – December 2021, the changing COVID measures forced us to be creative to get into contact with eligible patients and obtain the desired data for both EFFECT and PERSPECTIVE. Despite the resulting delay in recruitment, at the end of the second period, 234 patients of the 350 in total have been included for EFFECT and inclusion of final patients is expected by September 2022. For PERSPECTIVE we expect to have sufficient data by March 2022.
During the second reporting period, July 2020 – December 2021, the changing COVID measures forced us to be creative to get into contact with eligible patients and obtain the desired data for both EFFECT and PERSPECTIVE. Despite the resulting delay in recruitment, at the end of the second period, 234 patients of the 350 in total have been included for EFFECT and inclusion of final patients is expected by September 2022. For PERSPECTIVE we expect to have sufficient data by March 2022.
Treatment of breast cancer, regardless of the stage of disease, compromises patients’ physical, mental and social health. PREFERABLE aims to improve the QoL and consequently contribute to the well-being of patients with MBC. The EFFECT clinical trial will demonstrate the (cost)-
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.
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.