Evidence map›Paper›PMID 37198562›Full record

ArticleBMC cancer2023

A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study.

Chloé Drozd, Elsa Curtit, Quentin Jacquinot, Charlène Marquine, Laura Mansi, Loïc Chaigneau, Erion Dobi, Julien Viot, Guillaume Meynard, Marie-Justine Paillard and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04867096 (Effects of a Supervised Exercise on Sleep in Patients With Non Metastatic Breast Cancer During Chemotherapy), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% 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.

NCT04867096 naunknown statusnot on this map

Effects of a Supervised Exercise on Sleep in Patients With Non Metastatic Breast Cancer During Chemotherapy

TypeinterventionalSponsorCentre Hospitalier Universitaire de BesanconRan2021 to 2023Enrolled60ConditionsBreast CancerArmsPhysical activity
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Cardiovascular training for fatigue in people with cancer.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
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

18 authors at 4 institutions in 1 country.

Chloé DrozdSports Science Faculty, University of Franche-Comté, Besançon, 25000, France. chloe.drozd@hotmail.fr.
Elsa CurtitDepartment of Medical Oncology, University Hospital, Besançon, 25000, France.
Quentin JacquinotResearch Unit EA3920, University of Franche-Comté, Besançon, 25000, France.
Charlène MarquineSports Science Faculty, University of Franche-Comté, Besançon, 25000, France.
Laura MansiDepartment of Medical Oncology, University Hospital, Besançon, 25000, France.
Loïc ChaigneauDepartment of Medical Oncology, University Hospital, Besançon, 25000, France.
Erion DobiDepartment of Medical Oncology, University Hospital, Besançon, 25000, France.
Julien ViotDepartment of Medical Oncology, University Hospital, Besançon, 25000, France.
Guillaume MeynardDepartment of Medical Oncology, University Hospital, Besançon, 25000, France.
Marie-Justine PaillardDepartment of Medical Oncology, University Hospital, Besançon, 25000, France.
Morgan GoujonDepartment of Medical Oncology, University Hospital, Besançon, 25000, France.
Pauline RouxDepartment of Physiology-Functional Explorations, University Hospital, Besançon, 25000, France.
Dewi VernereyMethodology and Quality of Life Unit, UMR 1098, University Hospital, Besançon, 25000, France.
Valérie GilletSleep Medicine Center, Ellipse, Besançon, 25000, France.
Hubert BourdinResearch Unit EA481, Unit of Sleep Disorder, University of Franche-Comté, Besançon, 25000, France.
Silvio GalliDepartment of Neurology, University Hospital, Besançon, 25000, France.
Nathalie MeneveauDepartment of Medical Oncology, University Hospital, Besançon, 25000, France.
Fabienne MouginSports Science Faculty, University of Franche-Comté, Besançon, 25000, France.
Centre Hospitalier Universitaire de Besançon · FRUniversité de franche-comté · FRInserm · FRMethodology and Quality of Life Unit in Oncology · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUp to 70% of breast cancer patients report symptoms of insomnia during and after treatment. Despite the ubiquity of insomnia symptoms, they are under-screened, under-diagnosed and poorly managed in breast cancer patients. Sleep medications treat symptoms but are ineffective to cure insomnia. Other approaches such as cognitive behavioral therapy for insomnia, relaxation through yoga and mindfulness are often not available for patients and are complex to implement. An aerobic exercise program could be a promising treatment and a feasible option for insomnia management in breast cancer patients, but few studies have investigated the effects of such a program on insomnia.

methodsThis multicenter, randomized clinical trial evaluate the effectiveness of a moderate to high intensity physical activity program (45 min, 3 times per week), lasting 12 weeks, in minimizing insomnia, sleep disturbances, anxiety/depression, fatigue, and pain, and in enhancing cardiorespiratory fitness. Patients with breast cancer be recruited from six hospitals in France and randomly allocated to either the "training" or the "control" group. Baseline assessments include questionnaires [Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index questionnaire (PSQI), Hospital Anxiety Depression Scale (HADS), Epworth Sleepiness Scale (ESS)], home polysomnography (PSG), and 7-day actigraphy coupled with completion of a sleep diary. Assessments are repeated at the end of training program and at six-month follow-up. DISCUSSION: This clinical trial will provide additional evidence regarding the effectiveness of physical exercise in minimizing insomnia during and after chemotherapy. If shown to be effective, exercise intervention programs will be welcome addition to the standard program of care offered to patients with breast cancer receiving chemotherapy.

trial registrationNational Clinical Trials Number (NCT04867096).

Indexed as

Breast NeoplasmsSleep Initiation and Maintenance DisordersExerciseExercise TherapyFemaleHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicSleepTreatment OutcomeBreast cancerExerciseFatigueInsomniaPolysomnographySleepStudy protocolSupportive care

Identifiers

PMID37198562
PMCPMC10189975
OpenAlexW4377010529

What OpenQuestion holds

Textmetadata
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.