Periodic Reporting for period 4 - PREFERABLE (Project on Exercise for Fatigue Eradication in Advanced Breast cancer to improve quality of life)
Reporting period: 2023-07-01 to 2024-06-30
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 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 was to advance the standard of care in MBC by improving the quality of life for patients in a palliative setting using a non-pharmacological intervention combining supervised and unsupervised exercise with support of an app. Based on the results from a multinational randomised controlled phase 3 clinical trial (EFFECT trial; (cost-)effectiveness study), a social sciences study mapping the different perspectives of patients with MBC about exercising (PERSPECTIVE study) and mapping the challenges of delivering supervised exercise programs to patients in the different European healthcare systems, the PREFERABLE project has generated 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 has contributed towards reshaping medical practice and will add to clinical guidelines and recommendations.
PREFERABLE’s vision was to advance the standard of care in MBC by improving the quality of life for patients in a palliative setting using a non-pharmacological intervention combining supervised and unsupervised exercise with support of an app. Based on the results from a multinational randomised controlled phase 3 clinical trial (EFFECT trial; (cost-)effectiveness study), a social sciences study mapping the different perspectives of patients with MBC about exercising (PERSPECTIVE study) and mapping the challenges of delivering supervised exercise programs to patients in the different European healthcare systems, the PREFERABLE project has generated 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 has contributed towards reshaping medical practice and will add to clinical guidelines and recommendations.
In the beginning, the project focused on the setup of the EFFECT randomized clinical trial as well as the PERSPECTIVE study. The first patient for the EFFECT trial was enrolled in January 2020. The COVID-19 pandemic caused some challenges in the recruitment and execution of the studies. Nevertheless, it also enabled us to be creative to get into contact with eligible patients and obtain the desired data for both EFFECT and PERSPECTIVE. All in all, the data for PERSPECTIVE was complete by March 2022 and for EFFECT the final patient completed the exercise program in May 2023.
The results from EFFECT demonstrate that exercise significantly reduces physical fatigue and improves health-related quality of life of patients living with MBC. Moreover, other benefits include improvements in physical fitness, physical, role (i.e. functioning in occupational and social roles), and social functioning, as well as reduction in pain, dyspnea, and sexual health issues. Besides the beneficial effects, we demonstrated that this non-pharmacological intervention is cost-effective. A biobank has been established and biomarker analyses are currently ongoing.
The PERSPECTIVE study revealed that while patients generally viewed exercise positively, they also faced significant barriers to starting exercise such as fatigue, pain, dyspnea, uncertainties about exercise routines, program accessibility, and costs. Interviews with 22 stakeholders, including healthcare professionals, policy makers, and exercise professionals, highlighted systemic issues such as lack of routine exercise discussions, inadequate knowledge and collaboration, and limited insurance coverage.
We have widely disseminated our results. They were presented at important conferences (e.g. the San Antonio Breast Cancer Symposium), in publications (including the high impact journals Nature Medicine and Journal of Clinical Oncology) and at the project’s closing symposium taking place on June 29, 2024. We have used our findings to create specific recommendations about integrating exercise in the care or patients with metastatic breast cancer and a brochure for patients and patient advocates, which can be downloaded from the project’s website.
The results from EFFECT demonstrate that exercise significantly reduces physical fatigue and improves health-related quality of life of patients living with MBC. Moreover, other benefits include improvements in physical fitness, physical, role (i.e. functioning in occupational and social roles), and social functioning, as well as reduction in pain, dyspnea, and sexual health issues. Besides the beneficial effects, we demonstrated that this non-pharmacological intervention is cost-effective. A biobank has been established and biomarker analyses are currently ongoing.
The PERSPECTIVE study revealed that while patients generally viewed exercise positively, they also faced significant barriers to starting exercise such as fatigue, pain, dyspnea, uncertainties about exercise routines, program accessibility, and costs. Interviews with 22 stakeholders, including healthcare professionals, policy makers, and exercise professionals, highlighted systemic issues such as lack of routine exercise discussions, inadequate knowledge and collaboration, and limited insurance coverage.
We have widely disseminated our results. They were presented at important conferences (e.g. the San Antonio Breast Cancer Symposium), in publications (including the high impact journals Nature Medicine and Journal of Clinical Oncology) and at the project’s closing symposium taking place on June 29, 2024. We have used our findings to create specific recommendations about integrating exercise in the care or patients with metastatic breast cancer and a brochure for patients and patient advocates, which can be downloaded from the project’s website.
Treatment of breast cancer, regardless of the stage of disease, compromises patients’ physical, mental and social health. PREFERABLE has aimed to improve the QoL and consequently contribute to the well-being of patients with MBC. A participant from Spain described our study as: “Wonderful. Even though I am very ill with chemotherapy, I come, I exercise, and I leave better.” The EFFECT trial is the first well powered randomized trial including patients with MBC. The trial has demonstrated the effectiveness of the exercise intervention in reducing the most common and burdensome side-effect, i.e. cancer-related fatigue (first primary endpoint), and improving health-related QoL (second primary endpoint) in the palliative setting. The exercise intervention was also cost-effective, which means that the additional costs of the intervention were compensated by cost savings in health care and societal expenses and a higher quality of life.