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The primary objective of the \u2018dispositif connect\u00e9\u2019, that is,\n connected device in English trial is to evaluate the efficacy of two\n 6-month exercise interventions, either single or combined, concomitant\n to adjuvant treatments, on the physical activity level of patients with\n breast cancer, compared with usual care: an exercise programme using a\n connected device (activity tracker, smartphone application, website) and\n a therapeutic patient education intervention. Secondary objectives are\n to evaluate adherence to interventions, their impact at 6 and 12 months,\n representations and acceptability of interventions, and to assess the\n cost-effectiveness of the interventions using quality-adjusted\n life-years.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n This is a 2\u00d72 factorial, multicentre, phase III randomised\n controlled trial. The study population (with written informed consent)\n will consist of 432\u2009women diagnosed with primary localised invasive\n breast carcinoma and eligible for adjuvant chemotherapy, hormonotherapy\n and\/or radiotherapy. They will be randomly allocated between one of four\n arms: (1) web-based connected device (evolving target number of daily\n steps and an individualised, semisupervised, adaptive programme of two\n walking and one muscle strengthening sessions per week in autonomy), (2)\n therapeutic patient education (one educational diagnosis, two collective\n educational sessions, one evaluation), (3) combination of both\n interventions and (4) control. All participants will receive the\n international physical activity recommendations. Assessments (baseline,\n 6 and 12 months) will include physical fitness tests, anthropometrics\n measures, body composition (CT scan, bioelectrical impedance),\n self-administered questionnaires (physical activity profile (Recent\n Physical Activity Questionnaire), quality of life (European Organization\n for Research and Treatment of Cancer Quality-Of-Life Questionnaire-30,\n EQ-5D-5L), fatigue (Piper Fatigue Scale-12), social deprivation\n (Evaluation of Deprivation and Inequalities in Health Examination\n Centres), lifestyle, physical activity barriers, occupational status)\n and biological parameters (blood draw).<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n This study was reviewed and approved by the French Ethics Committee.\n The findings will be disseminated to the scientific and medical\n community via publications in peer-reviewed journals and conference\n presentations.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n NCT03529383<\/jats:ext-link>; Pre-results.<\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-045448","type":"journal-article","created":{"date-parts":[[2022,11,4]],"date-time":"2022-11-04T15:12:15Z","timestamp":1667574735000},"page":"e045448","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["Connected device and therapeutic patient education to promote physical\n activity among women with localised breast cancer (DISCO trial): protocol\n for a multicentre 2\u00d72 factorial randomised controlled trial"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct03529383","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9900-5861","authenticated-orcid":false,"given":"Marina","family":"Touillaud","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1309-5390","authenticated-orcid":false,"given":"Baptiste","family":"Fournier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"P\u00e9rol","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1240-5390","authenticated-orcid":false,"given":"Lidia","family":"Delrieu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aur\u00e9lia","family":"Maire","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elodie","family":"Belladame","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"P\u00e9rol","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4487-8723","authenticated-orcid":false,"given":"Lionel","family":"Perrier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Preau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanguy","family":"Leroy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Baptiste","family":"Fassier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florie","family":"Fillol","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e9bastien","family":"Pascal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thierry","family":"Durand","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B\u00e9atrice","family":"Fervers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,9,13]]},"reference":[{"key":"2022110304312643000_11.9.e045448.1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21492"},{"key":"2022110304312643000_11.9.e045448.2","unstructured":"Defossez G , Le Guyader-Peyrou S , Uhry Z .\n Estimations nationales de l\u2019incidence et de la mortalit\u00e9 par cancer en\n France m\u00e9tropolitaine entre 1990 et 2018. \u00c9tude partir des registres des\n cancers du r\u00e9seau Francim. 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