[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100207433":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":12,"locations":30,"responsibleParty":52,"collaborators":12,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":12,"enrollmentInfo":64,"targetDuration":12,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":84,"whyStopped":12,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Centre Antoine Lacassagne","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"A: Standard medical care","NO_INTERVENTION","Arm A: standard supervision and medical care during an adjuvant chemotherapy treatment in France",null,{"label":14,"type":15,"description":16,"interventionNames":17},"B: telephonic monitoring","EXPERIMENTAL","Arm B: telephonic monitoring during inter-treatment intervals + personalized medical care.",[18],"Other: Clinical and psychosocial phone calls",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Clinical and psychosocial phone calls","The standard medical supervision is defined as follows:\n\n* Prescription of prophylactics medication (corticoid, antiemetic, cream, mouthwash, etc) at each cycle of chemotherapy.\n* Nominative notebook containing details of chemotherapy administered and medical contacts.\n* Consultations with psycho-oncologist or psychiatrist (if necessary).\n\nThe intervention further comprises: nurse phone calls the 3rd and the 8th day of the first three cycles of treatment, and personalized medical care according to toxicities reported.",[14],[25],"medical care including social and psychological domains",[27],{"name":28,"affiliation":5,"role":29},"Philippe FOLLANA, Dr.","PRINCIPAL_INVESTIGATOR",[31,43],{"facility":5,"status":12,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":12},"Nice","Cedex 2","06189","France","FR",{"type":38,"coordinates":39},"Point",[40,41],7.26608,43.70313,{"lat":41,"lon":40},{"facility":44,"status":12,"city":45,"state":12,"zip":46,"country":35,"countryCode":36,"cosmosGeoPoint":47,"geoPoint":51,"contacts":12},"Polyclinique St Jean","Cagnes-sur-Mer","06800",{"type":38,"coordinates":48},[49,50],7.1479,43.66352,{"lat":50,"lon":49},{"type":53,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100207433","impact-of-a-telephonic-monitoring-during-inter-treatment-intervals-on-emotional-state-quality-of-life-and-toxicities-on-neo-adjuvant-or-adjuvant-chemotherapy-treated-patients-100207433",false,"NCT01977053","Impact of a Telephonic Monitoring During Inter-treatment Intervals on Emotional State, Quality of Life and Toxicities, on Neo Adjuvant or Adjuvant Chemotherapy-treated Patients","Impact of a Telephonic Monitoring During Neo Adjuvant or Adjuvant Chemotherapy","EMOTION","Inclusion Criteria:\n\n* Patient older than 18.\n* Patient surgically-treated or no for non inflammatory breast cancer or for colon cancer or rectal cancer.\n* Patient to be treated by neo-adjuvant or adjuvant chemotherapy by 5-fluorouracil, epirubicin and cyclophosphamide (FEC)-docetaxel, docetaxel-cyclophosphamide, 5-fluorouracil\u002Fleucovorin with oxaliplatin(FOLFOX) or XELOX. A treatment with trastuzumab is allowed in association.\n* Patient never treated by chemotherapy.\n* Patient with Performance Status under or equal to 2.\n* Patient with adequate hematopoietic, hepatic and cardiac functions according to the investigator.\n* Patient having read with the information note and having signed the informed consent.\n* Patient beneficiating from French health insurance cover.\n\nExclusion Criteria:\n\n* Patient with psychological state, geographical remote or social problems that contraindicated the participation into the study according to the investigator.\n* Patient that must be treated for a metastatic disease.\n* Patient not able to attend all study visits.\n* Patient not understanding French.\n* Patient who don't have a phone.\n* Vulnerable patient: pregnant or breast-feeding women, person deprived of freedom by an administrative or judicial decision, person older than 18 being the object of a legal protection measure or outside state to express their consent.","ALL","18 Years",{"count":65,"type":66},274,"ACTUAL","INTERVENTIONAL",[69],"NA","In health care, the phone has emerged as a clinical tool in its own right, especially for the development of psychological support to patients and that, in many pathologies. Its potential in the development of psycho-social support was quickly identified.\n\nHowever, to our knowledge, no prospective, randomized studies have evaluated the impact of a telephone call to both the anxiety and the management of side effects of neoadjuvant or adjuvant chemotherapy.\n\nThe patient incomplete care by the hospital system and the general practitioner during chemotherapy, as well as the lack of information and poor preparation and \u002F or management of side effects, are a source of distress and lead to a decrease quality of life for the patient and his family.\n\nWe propose to determine on a population of 280 patients, the impact of two phone calls during 3 first inter-treatment intervals on the overall measure of mood states of the patient and his principal caregiver (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation). We will also study the gain in quality of life, on anxiety level, frequency and severity of toxicities, as well as emotional comfort of the procedure.",[72,73,74,75],"Non-metastatic Patients With Breast Cancer","Non-metastatic Patients With Colon Cancer","Non-metastatic Patients With Rectal Cancer","Patients Undergoing Adjuvant Chemotherapy",[77,78,79,80,81,82,83],"breast cancer","colon cancer","rectal cancer","adjuvant chemotherapy","phone calls","emotional states","quality of life","COMPLETED","2026-04-20",{"date":87,"type":66},"2026-04-23",{"date":89,"type":12},"2013-09",{"date":91,"type":66},"2018-12",{"name":5,"class":6},2]