TY - JOUR
T1 - 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
T2 - the EFFECT study
AU - Hiensch, Anouk E
AU - Monninkhof, Evelyn M
AU - Schmidt, Martina E
AU - Zopf, Eva M
AU - Bolam, Kate A
AU - Aaronson, Neil K
AU - Belloso, Jon
AU - Bloch, Wilhelm
AU - Clauss, Dorothea
AU - Depenbusch, Johanna
AU - Lachowicz, Milena
AU - Pelaez, Mireia
AU - Rundqvist, Helene
AU - Senkus, Elzbieta
AU - Stuiver, Martijn M
AU - Trevaskis, Mark
AU - Urruticoechea, Ander
AU - Rosenberger, Friederike
AU - van der Wall, Elsken
AU - de Wit, G Ardine
AU - Zimmer, Philipp
AU - Wengström, Yvonne
AU - Steindorf, Karen
AU - May, Anne M
N1 - Funding Information:
The EFFECT study is part of the PREFERABLE project and has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 825677. The study is also funded by the National Health and Medical Research Council of Australia (2018/GNT1170698).
Funding Information:
We would like to thank all members of our advisory committee, including Fatima Cordoso, Michael van den Berg, Dorte Gyrd-Hansen, Anna Campbell, Kathryn Schmitz, Mats Börjesson, and Monique Simons, for their advice regarding the design of the EFFECT study. We would like to thank Julius Clinical for providing us with protocol assistance and supporting the ethical approval procedure in all centers. We would like to thank Prue Cormie and Joachim Wiskemann for their valuable input regarding the design of the study. Finally, we would like to thank Europa Donna for being involved in the design of the EFFECT study, ensuring that patients’ and caregivers’ perspectives are accurately represented.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/7/29
Y1 - 2022/7/29
N2 - 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.
AB - 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.
KW - Exercise
KW - Fatigue
KW - Metastatic breast cancer
KW - Quality of life
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85135197381&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06556-7
DO - 10.1186/s13063-022-06556-7
M3 - Article
C2 - 35906659
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
M1 - 610
ER -