[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423455":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":203,"collaborators":205,"id":211,"slug":212,"hasResults":213,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":213,"sex":219,"minAge":220,"maxAge":221,"enrollmentInfo":222,"targetDuration":18,"studyType":225,"phases":226,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},{"fullName":5,"class":6},"Centre Hospitalier Emile Roux","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group with the therapeutic education and nursing support program","EXPERIMENTAL","In addition to the conventional oncology follow-up, patients will participate in an initial educational assessments day.",[13],"Other: Therapeutic Education and Nursing Support Program for Supportive Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Patients will have the conventional oncology follow-up.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Therapeutic Education and Nursing Support Program for Supportive Care","In addition to the conventional oncology follow-up, patients will participate in an initial educational assessment day within 15 days before or after their first dose of hormone therapy.\n\nA discussion between the patient and the pivot nurse will then make it possible to define personalized objectives, thus guiding the choice of workshops in the outpatient educational program.",[9],[25],{"name":26,"affiliation":5,"role":27},"Séverine Breysse","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Émilie GADEA, PhD","CONTACT","+33 4 71 04 35 38","projetetaph@ch-lepuy.fr",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Camille FARCY, PhD","+33 4 71 04 31 27","camille.farcy@ch-lepuy.fr",[39,62,81,99,119,132,147,166,185],{"facility":40,"status":41,"city":42,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Centre Hospitalier de Bourg-en-Bresse \u002F Fleyriat","RECRUITING","Bourg-en-Bresse","01000","France","FR",{"type":47,"coordinates":48},"Point",[49,50],5.2258,46.20574,{"lat":50,"lon":49},[53,57,61],{"name":54,"role":31,"phone":55,"phoneExt":18,"email":56},"Patrick ARNAUD-COFFIN, MD","+33 4 74 45 43 38","parnaudcoffin@ch-bourg01.fr",{"name":58,"role":31,"phone":59,"phoneExt":18,"email":60},"Mélanie CHAGROS","+33 4 74 45 41 34","mchagros@ch-bourg01.fr",{"name":54,"role":27,"phone":18,"phoneExt":18,"email":18},{"facility":63,"status":41,"city":64,"state":18,"zip":65,"country":44,"countryCode":45,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Clinique De L'infirmerie Protestante De Lyon","Caluire-et-Cuire","69300",{"type":47,"coordinates":67},[68,69],4.8464,45.79462,{"lat":69,"lon":68},[72,76,80],{"name":73,"role":31,"phone":74,"phoneExt":18,"email":75},"Christine DOLMAZON, MD","+33 4 72 00 71 30","medecineinterne@infirmerie-protestante.com",{"name":77,"role":31,"phone":78,"phoneExt":18,"email":79},"Polina KUKLINA","+33 4 26 29 79 27","Polina.KUKLINA@infirmerie-protestante.com",{"name":73,"role":27,"phone":18,"phoneExt":18,"email":18},{"facility":82,"status":41,"city":83,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"CH de Carcassonne","Carcassonne",{"type":47,"coordinates":85},[86,87],2.34863,43.21649,{"lat":87,"lon":86},[90,94,98],{"name":91,"role":31,"phone":92,"phoneExt":18,"email":93},"Samir HACENE, MD","+33 4 68 24 29 77","samir.hacene@ch-carcassonne.fr",{"name":95,"role":31,"phone":96,"phoneExt":18,"email":97},"Pauline BAILLETTE-TEXIER","+33 4 68 24 23 72","pauline.baillette@ch-carcassonne.fr",{"name":91,"role":27,"phone":18,"phoneExt":18,"email":18},{"facility":100,"status":101,"city":102,"state":18,"zip":103,"country":44,"countryCode":45,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"CHAL - 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Hôpital Nord","Saint-Priest-en-Jarez","42270",{"type":47,"coordinates":171},[172,173],4.37678,45.4739,{"lat":173,"lon":172},[176,180,184],{"name":177,"role":31,"phone":178,"phoneExt":18,"email":179},"Elodie GUILLAUME, MD","+33 4 77 91 71 02","elodie.guillaume@chu-st-etienne.fr",{"name":181,"role":31,"phone":182,"phoneExt":18,"email":183},"Kenza KALI","+33 4 77 82 29 74","Kenza.KALI@chu-st-etienne.fr",{"name":177,"role":27,"phone":18,"phoneExt":18,"email":18},{"facility":186,"status":41,"city":187,"state":18,"zip":188,"country":44,"countryCode":45,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Médipôle Lyon-Villeurbanne","Villeurbanne","69100",{"type":47,"coordinates":190},[191,192],4.8795,45.76601,{"lat":192,"lon":191},[195,199,202],{"name":196,"role":31,"phone":197,"phoneExt":18,"email":198},"Victor PASSERAT, MD","+33 4 26 68 67 67","v.passerat@free.fr",{"name":200,"role":31,"phone":18,"phoneExt":18,"email":201},"Caroline JAFFRE","C.JAFFRE@resamut.fr",{"name":196,"role":27,"phone":18,"phoneExt":18,"email":18},{"type":204,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[206,208],{"name":207,"class":6},"University Hospital, Clermont-Ferrand",{"name":209,"class":210},"Walisco","UNKNOWN","100423455","therapeutic-education-and-nursing-support-program-for-supportive-care-in-patients-treated-with-hormone-therapy-for-non-metastatic-breast-cancer-100423455",false,"NCT04794075","Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer","Programme d'Éducation Thérapeutique et d'Accompagnement Infirmier Vers Les Soins de Support, Chez Les Patientes Sous Hormonothérapie Pour un Cancer du Sein Non métastatique","ETAPH","Inclusion Criteria:\n\n* Female patients aged 18 to 75 years inclusive\n* Patients with non-metastatic breast cancer for whom adjuvant hormone therapy (anti-oestrogen or anti-aromatase) is indicated, depending on the decision of the multidisciplinary consultation meeting.\n* Performance status (ECOG) ≤ 2\n* Patient able to read and understand French (common use)\n* Patient with access to an internet connection (for collection of adverse events and responses to questionnaires on the electronic platform)\n* Patient who has been informed and has given written consent to participate in the study\n* Patient affiliated to the French social security system or equivalent\n\nExclusion Criteria:\n\n* Patient with metastatic cancer (stage IV)\n* Patient undergoing neoadjuvant hormone therapy\n* Patient who started hormone therapy prior to inclusion in the study\n* Patient with a history of other cancer treated by radiotherapy, chemotherapy or hormone therapy, with an end of treatment less than 2 years ago.\n* For patients in the experimental group: Inability of the patient to travel to the hospital to attend the initial assessment day and the proposed group outpatient workshops; follow-up of the program difficult for geographical, physical or other reasons (at the discretion of the investigator).\n* For patients in the control group: patients for whom telephone nursing follow-up is planned for 2 months or more or more than 4 sessions of therapeutic education.\n* Pregnant and breastfeeding women\n* Patient with a documented history of cognitive or psychiatric disorders\n* Refusal to participate, protected adult patient, under guardianship or curatorship","FEMALE","18 Years","75 Years",{"count":223,"type":224},300,"ESTIMATED","INTERVENTIONAL",[227],"NA","To compare the efficacy of the addition of a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone, on the management of adverse events (AEs) related to adjuvant hormone therapy during the first year of treatment in patients with non-metastatic breast cancer.",[230],"Neoplasm of Breast",[232,233,234,235,236],"Therapeutic Education","Nursing Support Program","Hormone Therapy","Non-metastatic Breast Cancer","Breast Cancer","2025-07-30",{"date":239,"type":240},"2025-08-03","ACTUAL",{"date":242,"type":240},"2021-08-09",{"date":244,"type":224},"2027-08",{"name":5,"class":6},9]