[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544313":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":42,"studyPopulation":11,"armGroups":43,"interventions":55,"overallOfficials":64,"centralContacts":76,"locations":83,"responsibleParty":104,"collaborators":11,"id":106,"slug":11,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":11,"eligibilityCriteria":110,"healthyVolunteers":107,"sex":111,"minAge":112,"maxAge":11,"enrollmentInfo":113,"targetDuration":11,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":11,"overallStatus":86,"whyStopped":11,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"University of Erlangen-Nürnberg Medical School","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change in rates of weight loss with additional app-based Patient Care",null,"during trial, about 24 months",[14,16,18,20,22,24,26,28,30,32],{"measure":15,"description":11,"timeFrame":12},"Frequency of deteriorations in health status subjectively reported by patients and recorded via the app.",{"measure":17,"description":11,"timeFrame":12},"Frequency of additional app-triggered contacts of the clinic with the patients",{"measure":19,"description":11,"timeFrame":12},"Frequency of critical health conditions (physician-verified) detected earlier by the app.",{"measure":21,"description":11,"timeFrame":12},"Change in quality of life measured per questionnaires",{"measure":23,"description":11,"timeFrame":12},"Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy.",{"measure":25,"description":11,"timeFrame":12},"Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy.",{"measure":27,"description":11,"timeFrame":12},"Rate of therapy interruptions\u002Fdiscontinuations",{"measure":29,"description":11,"timeFrame":12},"Overall survival",{"measure":31,"description":11,"timeFrame":12},"Disease-free\u002Fprogression-free survival",{"measure":33,"description":11,"timeFrame":12},"Change of Loco-regional tumor control",{"allocation":35,"interventionModel":36,"interventionModelDescription":11,"primaryPurpose":37,"observationalModel":11,"timePerspective":11,"maskingInfo":38},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":39,"maskingDescription":11,"whoMasked":40},"SINGLE",[41],"PARTICIPANT","Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.\n\nPatients in the experimental arm receive the daily reminder message via app (Emento) that they should pay attention to adequate caloric intake. In addition, these patients receive 3 screening questions about their current health and nutritional status twice a week.\n\nIn case of relevant deterioration (any negative value in the screening questions is explained under study procedure), additional further questions are asked, which are specifically aimed at the side effects of the tumor therapy (mainly dysphagia, pain). The answers will be transmitted to the radiation clinic.\n\nIf a question is answered positively, this is reported to the radiotherapy clinic on the one hand and on the other hand, the patient is asked to consult the doctor in the clinic as soon as possible.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"App Usage","EXPERIMENTAL","Patients receive the daily reminder message via app (Emento) that they should pay attention to sufficient calorie intake. In addition, these patients receive 3 screening questions about their current health and nutritional status twice a week.",[49],"Procedure: App Usage",{"label":51,"type":6,"description":52,"interventionNames":53},"Standard","Patients in the control arm receive supportive care during and after radio(chemo)therapy according to hospital standards.",[54],"Other: Standard of Care",[56,60],{"type":57,"name":45,"description":58,"armGroupLabels":59,"otherNames":11},"PROCEDURE","Conducting patient surveys with app",[45],{"type":6,"name":61,"description":62,"armGroupLabels":63,"otherNames":11},"Standard of Care","supportive care during and after radio(chemo)therapy according to hospial standards",[51],[65,69,71,74],{"name":66,"affiliation":67,"role":68},"Marlen Haderlein, PD","Universitätsklinikum Erlangen, Radiation Oncology","STUDY_DIRECTOR",{"name":70,"affiliation":67,"role":68},"Luitpold Distel, Prof.",{"name":72,"affiliation":67,"role":73},"Allison Lamrani","PRINCIPAL_INVESTIGATOR",{"name":75,"affiliation":67,"role":73},"Charlotte Schmitter, Dr.",[77],{"name":78,"role":79,"phone":80,"phoneExt":81,"email":82},"Studiensekretariat","CONTACT","+49913185","33968","studiensekretariat.ST@uk-erlangen.de",[84],{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Universitätsklinikum Erlangen, Strahlenklinik","RECRUITING","Erlangen","Bavaria","91054","Germany","DE",{"type":93,"coordinates":94},"Point",[95,96],11.00783,49.59099,{"lat":96,"lon":95},[99,101,102,103],{"name":66,"role":79,"phone":80,"phoneExt":81,"email":100},"marlen.haderlein@uk-erlangen.de",{"name":78,"role":79,"phone":80,"phoneExt":81,"email":82},{"name":72,"role":73,"phone":11,"phoneExt":11,"email":11},{"name":75,"role":73,"phone":11,"phoneExt":11,"email":11},{"type":105,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100544313",false,"NCT06367257","App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy","Inclusion Criteria:\n\n* Patients with squamous cell carcinoma in the head and neck region, who receive a postsurgical or definitive radio(chemo)therapy\n* Patients who have a smartphone on which the Emento app can be installed\n* Minimum age 18 years\n\nExclusion Criteria:\n\n* Patients who are represented by a legal guardian\n* Patients who are not suitable for participation in the study due to a language barrier","ALL","18 Years",{"count":114,"type":115},148,"ESTIMATED","INTERVENTIONAL",[118],"NA","Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.",[121],"Squamous Cell Carcinoma of Head and Neck","2025-04-07",{"date":124,"type":125},"2025-04-10","ACTUAL",{"date":127,"type":125},"2024-02-29",{"date":129,"type":115},"2026-06-30",{"name":5,"class":6},1]