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

Journal article


Hiensch, Anouk, Monninkhof, Evelyn, Schmidt, Martina, Zopf, Eva Maria, Bolam, Kate, Aaronson, Neil, Belloso, Jon, Bloch, Wilhelm, Clauss, Dorothea, Depenbusch, Johanna, Lachowicz, Milena, Pelaez, Mireia, Rundqvist, Helene, Senkus, Elzbieta, Stuiver, Martijn, Trevaskis, Mark, Urruticoechea, Ander, Rosenberger, Friederike, van der Wall, Elsken, ... May, Anne. (2022). 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. Trials. 23(1), pp. 1-14. https://doi.org/10.1186/s13063-022-06556-7
AuthorsHiensch, Anouk, Monninkhof, Evelyn, Schmidt, Martina, Zopf, Eva Maria, Bolam, Kate, Aaronson, Neil, Belloso, Jon, Bloch, Wilhelm, Clauss, Dorothea, Depenbusch, Johanna, Lachowicz, Milena, Pelaez, Mireia, Rundqvist, Helene, Senkus, Elzbieta, Stuiver, Martijn, Trevaskis, Mark, Urruticoechea, Ander, Rosenberger, Friederike, van der Wall, Elsken, de Wit, G. Ardine, Zimmer, Philipp, Wengstrom, Yvonne, Steindorf, Karen and May, Anne
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.govNCT04120298. Registered on October 9, 2019.

KeywordsExercise; Fatigue; Metastatic breast cancer; Quality of life; Randomized controlled trial
Year01 Jan 2022
JournalTrials
Journal citation23 (1), pp. 1-14
PublisherBioMed Central
ISSN1745-6215
Digital Object Identifier (DOI)https://doi.org/10.1186/s13063-022-06556-7
Web address (URL)https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06556-7
Open accessPublished as ‘gold’ (paid) open access
Research or scholarlyResearch
Page range1-14
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Output statusPublished
Publication dates
Online29 Jul 2022
Publication process dates
Accepted16 Jul 2022
Deposited27 May 2024
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ARC Funded ResearchThis output has been funded, wholly or partially, under the Australian Research Council Act 2001
Grant IDGNT1170698
Additional information

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

https://clinicaltrials.gov/ct2/show/NCT04120298

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).

These funding bodies do not have any role during the execution, analyses, interpretation of the data, or decision to submit the results of this study.

© The Author(s) 2022.

This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Place of publicationUnited Kingdom
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