Evidence map›Paper›PMID 34427806›Full record

Trial reportBreast cancer research and treatment2021

Effects of exercise in breast cancer patients: implications of the trials within cohorts (TwiCs) design in the UMBRELLA Fit trial.

Roxanne Gal, Evelyn M Monninkhof, Carla H van Gils, Rolf H H Groenwold, Sjoerd G Elias, Desirée H J G van den Bongard, Petra H M Peeters, Helena M Verkooijen, Anne M May

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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

9 authors.

Roxanne GalJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands.
Evelyn M MonninkhofJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands.
Carla H van GilsJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands.
Rolf H H GroenwoldDepartment of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
Sjoerd G EliasJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands.
Desirée H J G van den BongardDepartment of Radiation Oncology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Petra H M PeetersJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands.
Helena M VerkooijenDivision of Imaging and Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Anne M MayJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands. A.M.May@umcutrecht.nl.ORCID http://orcid.org/0000-0003-0643-3790

Funding

ZonMw 016.156.050
6 · The paper itself

Abstract

purposeThe Trials within Cohorts (TwiCs) design aims to overcome problems faced in conventional RCTs. We evaluated the TwiCs design when estimating the effect of exercise on quality of life (QoL) and fatigue in inactive breast cancer survivors.

methodsUMBRELLA Fit was conducted within the prospective UMBRELLA breast cancer cohort. Patients provided consent for future randomization at cohort entry. We randomized inactive patients 12-18 months after cohort enrollment. The intervention group (n = 130) was offered a 12-week supervised exercise intervention. The control group (n = 130) was not informed and received usual care. Six-month exercise effects on QoL and fatigue as measured in the cohort were analyzed with intention-to-treat (ITT), instrumental variable (IV), and propensity scores (PS) analyses.

resultsFifty-two percent (n = 68) of inactive patients accepted the intervention. Physical activity increased in patients in the intervention group, but not in the control group. We found no benefit of exercise for dimensions of QoL (ITT difference global QoL: 0.8, 95% CI = - 2.2; 3.8) and fatigue, except for a small beneficial effect on physical fatigue (ITT difference: - 1.1, 95% CI = - 1.8; - 0.3; IV: - 1.9, 95% CI = - 3.3; - 0.5, PS: - 1.2, 95% CI = - 2.3; - 0.2).

conclusionTwiCs gave insight into exercise intervention acceptance: about half of inactive breast cancer survivors accepted the offer and increased physical activity levels. The offer resulted in no improvement on QoL, and a small beneficial effect on physical fatigue.

trial registrationNetherlands Trial Register (NTR5482/NL.52062.041.15), date of registration: December 07, 2015.

Indexed as

Breast NeoplasmsExercise TherapyFemaleHumansProspective StudiesQuality of LifeResearch DesignBreast cancerFatiguePhysical activityQuality of lifeTrials within cohortsTwiCs

Identifiers

PMID34427806
PMCPMC8557193

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.