Evidence map›Paper›PMID 35906659›Full record

ArticleTrials2022

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, Evelyn M Monninkhof, Martina E Schmidt, Eva M Zopf, Kate A Bolam, Neil K Aaronson, Jon Belloso, Wilhelm Bloch, Dorothea Clauss, Johanna Depenbusch and 14 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
3.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04120298 naactive not recruitingnot on this map

Effects of Structured and Individualized Exercise in Patients With Metastatic Breast Cancer on Fatigue and Quality of Life

TypeinterventionalSponsorUMC UtrechtRan2020 to 2027Enrolled357ConditionsMetastatic Breast CancerArmsSupervised exercise
NCT06138223 narecruitingnot on this mapstarted 2024, after this paper: background citation

The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2024 to 2028Enrolled196ConditionsGastroEsophageal Cancer, Incurable DiseaseArmsExercise intervention, Nutrition intervention
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 34 citations in OpenAlex.

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  4. Supervised Exercise for Patients With Metastatic Breast Cancer: A Cost-Utility Analysis Alongside the PREFERABLE-EFFECT Randomized Controlled Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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  19. Perspectives of patients with metastatic breast cancer on physical exercise programs: results from a survey in five European countries.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
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  20. PERSPECTIVEs on supervised exercise programs in people with metastatic breast cancer- a qualitative study in four European countries.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 11 institutions in 6 countries.

Anouk E Hiensch *Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.ORCID http://orcid.org/0000-0002-6216-2609
Evelyn M Monninkhof *Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.
Martina E Schmidt *Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany.
Eva M Zopf *Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.
Kate A Bolam *Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
Neil K AaronsonDivision of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Jon BellosoR&D department, Fundación Onkologikoa, Donostia-San Sebastian, Spain.
Wilhelm BlochDepartment of Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.
Dorothea ClaussDivision of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany.
Johanna DepenbuschDivision of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany.
Milena LachowiczDepartment of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.
Mireia PelaezR&D department, Fundación Onkologikoa, Donostia-San Sebastian, Spain.
Helene RundqvistDepartment of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.
Elzbieta SenkusDepartment of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.
Martijn M StuiverCenter for Quality of Life and Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Mark TrevaskisMary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.
Ander UrruticoecheaR&D department, Fundación Onkologikoa, Donostia-San Sebastian, Spain.
Friederike RosenbergerDepartment of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany.
Elsken van der WallDepartment of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
G Ardine de WitJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.
Philipp ZimmerDepartment of Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.
Yvonne Wengström *Cabrini Cancer Institute, The Szalmuk Family Department of Medical Oncology, Cabrini Health, Melbourne, Victoria, Australia.
Karen Steindorf *Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany.
Anne M May *Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands. A.M.May@umcutrecht.nl.
Utrecht University · NLGerman Cancer Research Center · DEGerman Sport University Cologne · DEOnkologikoa · ESGdańsk Medical University · PLKarolinska Institutet · SEThe Netherlands Cancer Institute · NLAustralian Catholic University · AUCabrini Hospital · AUHeidelberg University · DEKarolinska University Hospital · SE

Funding

H2020 European Research Council 825677
6 · The paper itself

Abstract

backgroundMany 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.

methodsThe 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 registrationClinicalTrials.gov NCT04120298 . Registered on October 9, 2019.

Indexed as

Breast NeoplasmsQuality of LifeActivities of Daily LivingExerciseExercise TherapyFatigueFemaleHumansRandomized Controlled Trials as TopicExerciseFatigueMetastatic breast cancerQuality of lifeRandomized controlled trial

Identifiers

PMID35906659
PMCPMC9335464
OpenAlexW4288693328

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.