[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100125782":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":11,"locations":29,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":11,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":85,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Centre Leon Berard","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Action Group","EXPERIMENTAL",null,[13],"Other: Action Group",{"label":15,"type":6,"description":11,"interventionNames":16},"Standard care",[17],"Other: Standard care",[19,22],{"type":6,"name":9,"description":20,"armGroupLabels":21,"otherNames":11},"On inclusion, a visit will be organized between the patient and at least 2 members of the DISSPO staff. It will allow an evaluation of supportive care needs and the proposition of a personalized care plan.\n\nThen, a consultation between the referring oncologist and the DISSPO will be organized once a month, so that the personalized care plan could be adapted if necessary.",[9],{"type":6,"name":15,"description":23,"armGroupLabels":24,"otherNames":11},"No specific intervention",[15],[26],{"name":27,"affiliation":5,"role":28},"CHVETZOFF Gisèle, MD","PRINCIPAL_INVESTIGATOR",[30,42,51],{"facility":31,"status":11,"city":32,"state":11,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":11},"Centre Léon Bérard","Lyon","69008","France","FR",{"type":37,"coordinates":38},"Point",[39,40],4.84789,45.74906,{"lat":40,"lon":39},{"facility":43,"status":11,"city":44,"state":11,"zip":45,"country":34,"countryCode":35,"cosmosGeoPoint":46,"geoPoint":50,"contacts":11},"Institut Curie","Paris","75005",{"type":37,"coordinates":47},[48,49],2.3488,48.85341,{"lat":49,"lon":48},{"facility":43,"status":11,"city":52,"state":11,"zip":53,"country":34,"countryCode":35,"cosmosGeoPoint":54,"geoPoint":58,"contacts":11},"Saint-Cloud","92210",{"type":37,"coordinates":55},[56,57],2.20289,48.84598,{"lat":57,"lon":56},{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100125782","study-of-impact-of-routine-clinical-cancer-departmentsupportive-care-department-consultation-on-the-prescription-of-an-additional-line-of-chemotherapy-100125782",false,"NCT00905281","Study of Impact of Routine \"Clinical Cancer Department\u002FSupportive Care Department\" Consultation on the Prescription of an Additional Line of Chemotherapy","Randomized Controlled Trial Assessing the Impact of Routine \"Oncologist-supportive Care Team\" Consultation on the Use of an Additional Line of Chemotherapy in Metastatic Breast Cancer Patients","Inclusion Criteria:\n\n* Woman aged \\>= 18 years\n* Metastatic breast cancer with visceral involvement\n* Patient requiring a 3rd or a 4th line of chemotherapy\n* Patient followed at Léon Bérard Cancer Center\n* Patient affiliated with social security\n* Patient able to read and write French\n* Written, voluntary, informed consent\n\nExclusion Criteria:\n\n* Ongoing chemotherapy other than third or fourth line\n* Only skin or bone metastasis\n* Follow-up impossible for social, geographical, familial or psychological reasons\n* Patient deprived of freedom\n* Pregnant or lactating woman","FEMALE","18 Years",{"count":71,"type":72},100,"ACTUAL","INTERVENTIONAL",[75],"NA","The purpose of this study is to assess the impact of systematic \"clinical cancer department\u002Fsupportive care department\" consultation meetings, versus standard care, on the prescription of an additional line of chemotherapy in patients with metastatic breast cancer and visceral involvement after 3 or 4 lines of chemotherapy.\n\nThis is a prospective paucicentric open label randomized controlled study with 2 parallel arms.\n\nEligible patients will be randomly assigned to either arm \"Study group\" or \"Standard care\".\n\nThe number of patients required to demonstrate a 30% reduction of the number of prescriptions for an additional line chemotherapy, assuming an alpha risk of 5% and 80% power, is 100 (50 in each arm).",[78],"Metastatic Breast Cancer",[80,81,82,83,84],"Metastatic breast cancer","Supportive care","Third or fourth line of chemotherapy","Quality of life","Treatment preferences","COMPLETED","2015-02-06",{"date":88,"type":89},"2015-02-09","ESTIMATED",{"date":91,"type":11},"2008-11",{"date":93,"type":72},"2014-06",{"name":5,"class":6},3]