Evidence map›Paper›PMID 34518245›Full record

ArticleBMJ open2021

Connected device and therapeutic patient education to promote physical activity among women with localised breast cancer (DISCO trial): protocol for a multicentre 2×2 factorial randomised controlled trial.

Marina Touillaud, Baptiste Fournier, Olivia Pérol, Lidia Delrieu, Aurélia Maire, Elodie Belladame, David Pérol, Lionel Perrier, Marie Preau, Tanguy Leroy and 5 more

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

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03529383 (Randomized Controlled Trial Evaluating the Efficacy of an Adapted Physical Activity Program Using a Connected Device With Activity Trackers and a Therapeutic Education Program Among Women With Localized Breast Cancer), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 34% 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.

NCT03529383 nacompletednot on this map

Randomized Controlled Trial Evaluating the Efficacy of an Adapted Physical Activity Program Using a Connected Device With Activity Trackers and a Therapeutic Education Program Among Women With Localized Breast Cancer

TypeinterventionalSponsorCentre Leon BerardRan2018 to 2022Enrolled436ConditionsBreast CancerArmsConnected device, Therapeutic education
3 · Its place in the literature

Who cites it

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

  1. Non-medical interventions to enhance return to work for people with cancer.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
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

15 authors at 4 institutions in 3 countries.

Marina TouillaudDepartment of Prevention Cancer Environment, Centre Léon Bérard, Lyon, France.ORCID 0000-0001-9900-5861
Baptiste FournierDepartment of Prevention Cancer Environment, Centre Léon Bérard, Lyon, France.ORCID 0000-0002-1309-5390
Olivia PérolDepartment of Prevention Cancer Environment, Centre Léon Bérard, Lyon, France.
Lidia DelrieuDepartment of Prevention Cancer Environment, Centre Léon Bérard, Lyon, France.ORCID 0000-0003-1240-5390
Aurélia MaireDepartment of Prevention Cancer Environment, Centre Léon Bérard, Lyon, France.
Elodie BelladameDepartment of Prevention Cancer Environment, Centre Léon Bérard, Lyon, France.
David PérolDepartment of of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.
Lionel PerrierDepartment of of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.ORCID 0000-0003-4487-8723
Marie PreauGRePS EA4163 Institute of Psychology, Lumière University Lyon 2, Bron, France.
Tanguy LeroyGRePS EA4163 Institute of Psychology, Lumière University Lyon 2, Bron, France.
Jean-Baptiste FassierUMRESTTE UMR T9405, Université Claude Bernard Lyon 1, Hospices Civils de Lyon, Lyon, France.
Florie FillolHospital Information, Biomouv, Paris, France.
Sébastien PascalHospital Information, Biomouv, Paris, France.
Thierry DurandDepartment of Hospital Information, Centre Léon Bérard, Lyon, France.
Béatrice FerversDepartment of Prevention Cancer Environment, Centre Léon Bérard, Lyon, France beatrice.fervers@lyon.unicancer.fr.
Université Claude Bernard Lyon 1 · FRCentre Léon Bérard · FRInserm · FRHealth Information Management · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDespite safety and benefits of physical activity during treatment of localised breast cancer, successful exercise strategies remain to be determined. The primary objective of the 'dispositif connecté', that is, connected device in English trial is to evaluate the efficacy of two 6-month exercise interventions, either single or combined, concomitant to adjuvant treatments, on the physical activity level of patients with breast cancer, compared with usual care: an exercise programme using a connected device (activity tracker, smartphone application, website) and a therapeutic patient education intervention. Secondary objectives are to evaluate adherence to interventions, their impact at 6 and 12 months, representations and acceptability of interventions, and to assess the cost-effectiveness of the interventions using quality-adjusted life-years. METHODS AND ANALYSIS: This is a 2×2 factorial, multicentre, phase III randomised controlled trial. The study population (with written informed consent) will consist of 432 women diagnosed with primary localised invasive breast carcinoma and eligible for adjuvant chemotherapy, hormonotherapy and/or radiotherapy. They will be randomly allocated between one of four arms: (1) web-based connected device (evolving target number of daily steps and an individualised, semisupervised, adaptive programme of two walking and one muscle strengthening sessions per week in autonomy), (2) therapeutic patient education (one educational diagnosis, two collective educational sessions, one evaluation), (3) combination of both interventions and (4) control. All participants will receive the international physical activity recommendations. Assessments (baseline, 6 and 12 months) will include physical fitness tests, anthropometrics measures, body composition (CT scan, bioelectrical impedance), self-administered questionnaires (physical activity profile (Recent Physical Activity Questionnaire), quality of life (European Organization for Research and Treatment of Cancer Quality-Of-Life Questionnaire-30, EQ-5D-5L), fatigue (Piper Fatigue Scale-12), social deprivation (Evaluation of Deprivation and Inequalities in Health Examination Centres), lifestyle, physical activity barriers, occupational status) and biological parameters (blood draw). ETHICS AND DISSEMINATION: This study was reviewed and approved by the French Ethics Committee. The findings will be disseminated to the scientific and medical community via publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT03529383; Pre-results.

Indexed as

Breast NeoplasmsQuality of LifeClinical Trials, Phase III as TopicExerciseFatigueFemaleHumansMulticenter Studies as TopicPatient Education as TopicRandomized Controlled Trials as Topicbreast tumoursmedical education & trainingsports medicine

Identifiers

PMID34518245
PMCPMC8438826
OpenAlexW3199469906

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.