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Effects of structured and individualized exercise in patients with metastatic breast cancer on fatigue and quality of life

The EFFECT study at a glance

  • Study objective: Improvement of fatigue and quality of life through targeted physical training

  • Target group: Patients with advanced breast cancer (i.e. metastatic breast cancer)

  • Study design: Randomized, controlled trial: 9-month multimodal exercise program compared to usual care

The study will be conducted in 5 EU countries (Germany, the Netherlands, Poland, Sweden, Spain) and Australia within the framework of the EU Horizon 2020 funded PREFERABLE project.

Further information on PREFERABLE can be found on the official website

Study coordination:

Prof. Dr. Anne May (UMC Utrecht)

Study center Heidelberg:

Prof. Dr. Karen Steindorf, Prof. Dr. Friederike Rosenberger, Dr. Martina Schmidt, Prof. Dr. Andreas Schneeweiss, PD Dr. Joachim Wiskemann


Numerous studies suggest that physical activity can lead to a reduction in treatment-related side effects such as fatigue, a reduction in depression symptoms and an increase in self-esteem among breast cancer patients receiving adjuvant therapy. The evidence for breast cancer patients with advanced disease is still scarce. However, due to the strong association between fatigue and reduced quality of life and impairment of everyday life, there is an urgent need for effective interventions that aim to reduce fatigue symptoms in metastatic breast cancer patients.

The aim of the EFFECT study is to investigate the role of targeted physical exercise for improvement of fatigue and quality of life among patients with metastatic breast cancer.

The EFFECT study is a randomized controlled trial. The intervention group participates in a 9-month multimodal exercise program, which consists of aerobic, strength and balance exercises. During the first six months, the participants attend a one-hour supervised exercise program twice a week and are encouraged to perform unsupervised exercise in addition. At the end of the six months, one supervised session per week is replaced by one unsupervised session, which is supported by an activity tracker (Fitbit) and a training app specially developed for the study. The control group is advised to avoid inactivity and to exercise at least 150 minutes per week depending on individual possibilities and circumstances. Patients in the control group also receive an activity tracker.

The primary endpoints of the study are cancer-related physical fatigue and health-related quality of life, which are collected after a period of six months and for sustainability of the effects also in a follow-up survey after nine months. In addition, breast cancer-specific quality of life, anxiety and depression, sleep, pain, treatment-related toxicities grade≥3, physical fitness, body composition, self-reported and objective physical activity levels, biomarkers as well as the cost-effectiveness and safety of the exercise intervention are investigated.

Current status

The recruitment has been completed in July 2022.


Dr. Martina Schmidt
phone: +49 6221 42 2220


PREFERABLE has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 825677.


Design of a multinational randomized controlled trial to assess the effects of structured and individualized exercise in patients with metastatic breast cancer on fatigue and quality of life: the EFFECT study.
Hiensch AE, Monninkhof EM, Schmidt ME, Zopf EM, Bolam KA, Aaronson NK, Belloso J, Bloch W, Clauss D, Depenbusch J, Lachowicz M, Pelaez M, Rundqvist H, Senkus E, Stuiver MM, Trevaskis M, Urruticoechea A, Rosenberger F, van der Wall E, de Wit GA, Zimmer P, Wengström Y, Steindorf K, May AM. Trials. 2022 Jul 29;23(1):610. doi: 10.1186/s13063-022-06556-7

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