Evidence map›Paper›PMID 32620149›Full record

ArticleBMC cancer2020

Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial.

Lidia Delrieu, Amélie Anota, Olivier Trédan, Damien Freyssenet, Aurélia Maire, Brice Canada, Baptiste Fournier, Olivia Febvey-Combes, Frank Pilleul, Amine Bouhamama and 6 more

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

Article in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04354233 (A National, Multicenter, Randomized Controlled Trial to Assess the Efficacy of a Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Women With Metastatic Breast Cancer), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.4field-weighted citation impact, top 36% 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.

NCT04354233 nacompletednot on this map

A National, Multicenter, Randomized Controlled Trial to Assess the Efficacy of a Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Women With Metastatic Breast Cancer

TypeinterventionalSponsorCentre Leon BerardRan2020 to 2025Enrolled124ConditionsMetastatic Breast CancerArmsPhysical activity intervention with connected devices
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 10 citations in OpenAlex.

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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

16 authors at 5 institutions in 1 country.

Lidia DelrieuDepartment of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.
Amélie AnotaMethodology and Quality of Life in Oncology unit (INSERM UMR 1098), University Hospital of Besançon, Besançon, France.
Olivier TrédanDepartment of Medical Oncology, Léon Bérard Cancer Center, Lyon, France.
Damien FreyssenetInter-University Laboratory of Human Movement Biology EA7424, Univ Lyon, University Jean Monnet Saint-Etienne, Saint-Etienne, France.
Aurélia MaireDepartment of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.
Brice CanadaLaboratory on Vulnerabilities and Innovations in Sport, University Claude Bernard Lyon 1, University of Lyon, Villeurbanne, France.
Baptiste FournierDepartment of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.
Olivia Febvey-CombesDepartment of Clinical Research and Innovation, Léon Bérard Cancer Center, Lyon, France.
Frank PilleulDepartment of Interventional Radiology, Léon Bérard Cancer Center, Lyon, France.
Amine BouhamamaDepartment of Interventional Radiology, Léon Bérard Cancer Center, Lyon, France.
Christophe CauxUniv Lyon, Université Claude Bernard Lyon 1, INSERM 1052, CNRS 5286, Cancer Research Center of Lyon (CRCL), Léon Bérard Cancer Center, Lyon, France.
Florence JolyMedical Oncology Department, Centre François Baclesse, Caen, France.
Béatrice FerversDepartment of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.
Vincent PialouxInter-University Laboratory of Human Movement Biology EA7424, University Claude Bernard Lyon 1, University of Lyon, Villeurbanne, France.
David PérolDepartment of Clinical Research and Innovation, Léon Bérard Cancer Center, Lyon, France.
Olivia PérolDepartment of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France. olivia.perol@lyon.unicancer.fr.
Centre de Recherche en Cancérologie de Lyon · FRInserm · FRUniversité Claude Bernard Lyon 1 · FRUniversité Bourgogne Franche-Comté · FRUniversité Jean Monnet · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with a metastatic breast cancer suffer from a deteriorated health-related quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program using connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer.

methodsABLE02 is a prospective, national, multicenter, randomized, controlled and open-label study. A total of 244 patients with a metastatic breast cancer, with at least one positive hormone receptor and a first-line chemotherapy planned, will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 h a day during the whole intervention (6 months) with at least three weekly walking sessions and quizzes each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Health-related quality of life will be assessed every 6 weeks and main assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application. DISCUSSION: An activity program based on a smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors.

trial registrationNCT number: NCT04354233 .

Indexed as

Quality of LifeAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsExercise TherapyFatigueFemaleFitness TrackersHumansMiddle AgedMobile ApplicationsMulticenter Studies as TopicProgression-Free SurvivalRandomized Controlled Trials as TopicResearch DesignSmartphoneConnected devicesE-healthFatigueHealth-related quality of lifeMetastatic breast cancerPhysical activity

Identifiers

PMID32620149
PMCPMC7333295
OpenAlexW3038464601

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.