[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496945":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":110,"collaborators":24,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":24,"enrollmentInfo":121,"targetDuration":24,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":135,"whyStopped":24,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Institut Cancerologie de l'Ouest","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Specific nursing support","EXPERIMENTAL","The caregivers benefit from specific nursing support.",[13],"Other: Specific nursing support",{"label":15,"type":16,"description":17,"interventionNames":18},"No specific nursing support","ACTIVE_COMPARATOR","Caregivers do not receive any specific support from the nurses.",[19],"Other: Non-specific nursing support",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"* 3 mandatory on-site nursing consultations with the patient's caregiver at inclusion, 6 months and 12 months post-randomisation.The caregivers will complete the questionnaires (Zarit scale, Hospital Anxiety and Depression scale, Medical Outcome Study Short Form - 36, Caregiver's satisfaction).\n* interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.\n\nNurses assess the general health of the caregiver and Identify the socio-professional situation of the caregiver",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Non-specific nursing support","Caregivers will only have to complete on site Health indicators, Zarit scale, Hospital Anxiety and Depression scale, Medical Outcome Study Short Form - 36 at inclusion, 6 months and 12 months post-randomisation.",[15],[30],{"name":31,"affiliation":32,"role":33},"Céline THOMAS, Nurse","Institut de Cancérologie de l'Ouest","PRINCIPAL_INVESTIGATOR",[35,40],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","(0)2 40 67 97 49","+33","celine.thomas@ico.unicancer.fr",{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},"Emilie DEBEAUPUIS","(0)240679844","emilie.debeaupuis@ico.unicancer.fr",[45,61,74,87,97],{"facility":46,"status":24,"city":47,"state":24,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"CH Cholet","Cholet","49300","France","FR",{"type":52,"coordinates":53},"Point",[54,55],-0.87974,47.05893,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":24,"phoneExt":24,"email":60},"Margot NOBLECOURT, MD","margot.noblecourt@ch-cholet.fr",{"facility":62,"status":24,"city":63,"state":24,"zip":64,"country":49,"countryCode":50,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Centre Antoine Lacassagne","Nice","06 189",{"type":52,"coordinates":66},[67,68],7.26608,43.70313,{"lat":68,"lon":67},[71],{"name":72,"role":36,"phone":24,"phoneExt":24,"email":73},"julie OUDIN, Nurse","Julie.oudin@nice.unicancer.fr",{"facility":75,"status":24,"city":76,"state":24,"zip":77,"country":49,"countryCode":50,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Centre Henri Bequerel","Rouen","76038",{"type":52,"coordinates":79},[80,81],1.09932,49.44313,{"lat":81,"lon":80},[84],{"name":85,"role":36,"phone":24,"phoneExt":24,"email":86},"Amel CONSTANTIN, Nurse","amel.benchemam@chb.unicancer.fr",{"facility":32,"status":24,"city":88,"state":24,"zip":89,"country":49,"countryCode":50,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Saint-Herblain","44805",{"type":52,"coordinates":91},[92,93],-1.651,47.21154,{"lat":93,"lon":92},[96],{"name":31,"role":36,"phone":24,"phoneExt":24,"email":39},{"facility":98,"status":24,"city":99,"state":24,"zip":100,"country":49,"countryCode":50,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"CH Mémorial de Saint Lo","Saint-Lô","50000",{"type":52,"coordinates":102},[103,104],-1.09031,49.11624,{"lat":104,"lon":103},[107],{"name":108,"role":36,"phone":24,"phoneExt":24,"email":109},"Emillie LEFEVRE, Nurse","emilie.lefevre@ch-stlo.fr",{"type":111,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100496945","assessment-and-prevention-of-caregiver-burden-in-oncology-100496945",false,"NCT05750836","Assessment and Prevention of Caregiver Burden in Oncology","PREPAC-01","Inclusion Criteria:\n\n* Caregiver designated by the patient;\n* Caregiver of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month;\n* Caregiver of patient already cared for by a nurse before inclusion or going to start a nursing follow-up;\n* Caregiver of a patient with a score ≥2 of social fragility and\u002For psychological fragility and\u002For nutritional fragility and\u002For complexity;\n\nExclusion Criteria:\n\n* Patient whose life expectancy is assumed to be \\\u003C 6 months;\n* Patient living in an institution (EHPAD, MAS, SSR, MCO, USLD) at inclusion;\n* Caregiver declared as having a pathology that could alter his\u002Fher capacity to support (psychiatric history, dementia…) or under guardianship.","ALL","18 Years",{"count":122,"type":123},250,"ESTIMATED","INTERVENTIONAL",[126],"NA","The goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (APN, nurse coordinator in French health care organisations) compared to a support focused on the patient. At the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety and quality of life.\n\nParticipants will caregivers of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month.\n\nResearchers will compare 2 groups : a group where caregivers benefit from specific nursing support and a group of caregivers with no specific nursing support.\n\nThe specific support includes 3 mandatory on-site nursing consultations with the patient's caregiver and interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.",[129,130],"Oncology","Caregiver Burden",[132,133,134,130],"Nurse","Supportive Care","Zarit scale","NOT_YET_RECRUITING","2023-06-26",{"date":138,"type":139},"2023-06-28","ACTUAL",{"date":141,"type":123},"2023-07",{"date":143,"type":123},"2027-06",{"name":5,"class":6},5]