Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Jul 29;23(1):610.
doi: 10.1186/s13063-022-06556-7.

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

Anouk E Hiensch #  1 , Evelyn M Monninkhof #  1 , Martina E Schmidt #  2 , Eva M Zopf #  3   4 , Kate A Bolam #  5 , Neil K Aaronson  6 , Jon Belloso  7 , Wilhelm Bloch  8 , Dorothea Clauss  2   8 , Johanna Depenbusch  2   9 , Milena Lachowicz  10 , Mireia Pelaez  7 , Helene Rundqvist  11 , Elzbieta Senkus  10 , Martijn M Stuiver  12   13 , Mark Trevaskis  3 , Ander Urruticoechea  7 , Friederike Rosenberger  14 , Elsken van der Wall  15 , G Ardine de Wit  1 , Philipp Zimmer  8   16 , Yvonne Wengström #  4   17 , Karen Steindorf #  2 , Anne M May #  18
Affiliations
Randomized Controlled Trial

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

Anouk E Hiensch et al. Trials. .

Abstract

Background: Many patients with metastatic breast cancer experience cancer- and treatment-related side effects that impair activities of daily living and negatively affect the quality of life. There is a need for interventions that improve quality of life by alleviating fatigue and other side effects during palliative cancer treatment. Beneficial effects of exercise have been observed in the curative setting, but, to date, comparable evidence in patients with metastatic breast cancer is lacking. The aim of this study is to assess the effects of a structured and individualized 9-month exercise intervention in patients with metastatic breast cancer on quality of life, fatigue, and other cancer- and treatment-related side effects.

Methods: The EFFECT study is a multinational, randomized controlled trial including 350 patients with metastatic breast cancer. Participants are randomly allocated (1:1) to an exercise or control group. The exercise group participates in a 9-month multimodal exercise program, starting with a 6-month period where participants exercise twice a week under the supervision of an exercise professional. After completing this 6-month period, one supervised session is replaced by one unsupervised session for 3 months. In addition, participants are instructed to be physically active for ≥30 min/day on all remaining days of the week, while being supported by an activity tracker and exercise app. Participants allocated to the control group receive standard medical care, general written physical activity advice, and an activity tracker, but no structured exercise program. The primary outcomes are quality of life (EORTC QLQ-C30, summary score) and fatigue (EORTC QLQ-FA12), assessed at baseline, 3, 6 (primary endpoint), and 9 months post-baseline. Secondary outcomes include physical fitness, physical performance, physical activity, anxiety, depression, pain, sleep problems, anthropometric data, body composition, and blood markers. Exploratory outcomes include quality of working life, muscle thickness, urinary incontinence, disease progression, and survival. Additionally, the cost-effectiveness of the exercise program is assessed. Adherence and safety are monitored throughout the intervention period.

Discussion: This large randomized controlled trial will provide evidence regarding the (cost-) effectiveness of exercise during treatment of metastatic breast cancer. If proven (cost-)effective, exercise should be offered to patients with metastatic breast cancer as part of standard care.

Trial registration: ClinicalTrials.gov NCT04120298 . Registered on October 9, 2019.

Keywords: Exercise; Fatigue; Metastatic breast cancer; Quality of life; Randomized controlled trial.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Recruitment and study procedures
See this image and copyright information in PMC

References

    1. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. doi: 10.3322/caac.21660. - DOI - PubMed
    1. Lu J, Steeg PS, Price JE, et al. Breast cancer metastasis: challenges and opportunities. Cancer Res. 2009;69(12):4951–4953. doi: 10.1158/0008-5472.CAN-09-0099. - DOI - PubMed
    1. Cardoso F, Spence D, Mertz S, et al. Global analysis of advanced/metastatic breast cancer: Decade report (2005–2015) Breast. 2018;39:131–138. doi: 10.1016/j.breast.2018.03.002. - DOI - PubMed
    1. Butt Z, Rosenbloom SK, Abernethy AP, et al. Fatigue is the most important symptom for advanced cancer patients who have had chemotherapy. J Natl Compr Cancer Netw. 2008;6(5):448–455. doi: 10.6004/jnccn.2008.0036. - DOI - PMC - PubMed
    1. Palesh OG, Collie K, Batiuchok D, et al. A longitudinal study of depression, pain, and stress as predictors of sleep disturbance among women with metastatic breast cancer. Biol Psychol. 2007;75(1):37–44. doi: 10.1016/j.biopsycho.2006.11.002. - DOI - PMC - PubMed

Publication types

Associated data