[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553237":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":144,"collaborators":146,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":153,"sex":159,"minAge":160,"maxAge":25,"enrollmentInfo":161,"targetDuration":25,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":119,"whyStopped":25,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"University Hospital Schleswig-Holstein","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","Standard skin care supported by a reminder app",[13,14],"Other: Standard skin care","Device: Reminder App",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm B","ACTIVE_COMPARATOR","Standard skin care alone",[13],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Standard skin care","From the start of radiotherapy, standard skin care has to be performed by the patient. This may vary at the participating centers. At the site in Lübeck, it includes fatty cream with 2-10% urea (fatty cream alone, if patients do not tolerate urea) and, in case of pruritus, addition of mometasone furoate cream. In case of grade ≥2 moist desquamation or grade ≥3 radiation dermatitis, each day antiseptic agents will be administered for wound cleansing followed by administration of silicon or calcium alginate bandage. This treatment will be continued until moist desquamation radiation disappears and radiation dermatitis improves to grade 2. Fatty cream with 2-10% urea is applied to the irradiated skin four times daily. Mometasone furoate cream: In addition to the fatty cream with 2-10% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.",[9,16],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DEVICE","Reminder App","In addition to standard skin care, patients are supported by a Reminder App. The purpose of the app is to remind the patients in an intuitive, unobtrusive and supportive way to perform skin care. By default, patients are reminded four times a day, but they will also be able to define a notification schedule that best suits their personal needs. The patients may postpone each required care procedure for up to 2 hours. With each procedure, the patients are guided through the skin care with simple and self-explanatory illustrations. To increase the patients' motivation, they will additionally earn points for regular and punctual performed care procedures. The patients receive a hand-out including instructions how to properly perform skin care, but they can also find an information page within the application that includes similar instructions.",[9],[32],{"name":33,"affiliation":34,"role":35},"Dirk Rades, MD, FASTRO","Dept. of Radiation Oncology, University of Lubeck, Germany","PRINCIPAL_INVESTIGATOR",[37,42],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","0049-451-500","45400","DIRK.RADES@UKSH.DE",{"name":43,"role":38,"phone":39,"phoneExt":44,"email":45},"Carlos A. Narvaez-Wolf, MD","45420","Carlos.Narvaez-Wolf@uksh.de",[47,67,85,101,117],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Vejle Hospital, University Hospital of Southern Denmark","NOT_YET_RECRUITING","Vejle","Southern Denmark","7100","Denmark","DK",{"type":56,"coordinates":57},"Point",[58,59],9.5357,55.70927,{"lat":59,"lon":58},[62],{"name":63,"role":38,"phone":64,"phoneExt":65,"email":66},"Charlotte Kristiansen, MD","0045-7940","6094","charlotte.kristiansen@rsyd.dk",{"facility":68,"status":49,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Medical Practice for Radiotherapy and Radiation Oncology","Hanover","Lower Saxony","30161","Germany","DE",{"type":56,"coordinates":75},[76,77],9.73322,52.37052,{"lat":77,"lon":76},[80],{"name":81,"role":38,"phone":82,"phoneExt":83,"email":84},"Stefan Janssen, MD","0049-511-220","60420","stefan.janssen@uksh.de",{"facility":86,"status":49,"city":87,"state":88,"zip":89,"country":72,"countryCode":73,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Medical School Hamburg, Schwerin Campus","Schwerin","Mecklenburg-Vorpommern","19055",{"type":56,"coordinates":91},[92,93],11.41316,53.62937,{"lat":93,"lon":92},[96],{"name":97,"role":38,"phone":98,"phoneExt":99,"email":100},"Marciana N Duma, MD","0049-385-520","5070","Marciana.Duma@helios-gesundheit.de",{"facility":102,"status":49,"city":103,"state":104,"zip":105,"country":72,"countryCode":73,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Malteser Hospital St. Franziskus","Flensburg","Schleswig-Holstein","24939",{"type":56,"coordinates":107},[108,109],9.43722,54.78805,{"lat":109,"lon":108},[112],{"name":113,"role":38,"phone":114,"phoneExt":115,"email":116},"Carmen Timke, MD","0049-461-816","2518","carmen.timke@malteser.org",{"facility":118,"status":119,"city":120,"state":25,"zip":121,"country":72,"countryCode":73,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein","RECRUITING","Lübeck","23562",{"type":56,"coordinates":123},[124,125],10.68729,53.86893,{"lat":125,"lon":124},[128,132,135,136,138,140,142],{"name":129,"role":38,"phone":130,"phoneExt":40,"email":131},"Dirk Rades, Prof. Dr.","+49-451-500","dirk.rades@uksh.de",{"name":133,"role":38,"phone":130,"phoneExt":44,"email":134},"Carlos Andres Narvaez","carlosandres.narvaez@uksh.de",{"name":129,"role":38,"phone":25,"phoneExt":25,"email":25},{"name":137,"role":38,"phone":25,"phoneExt":25,"email":25},"Liesa Dziggel, Dr.",{"name":139,"role":38,"phone":25,"phoneExt":25,"email":25},"Calos A Narvaez-Wolf, Dr.",{"name":141,"role":38,"phone":25,"phoneExt":25,"email":25},"Maike Radtke, Dr.",{"name":143,"role":38,"phone":25,"phoneExt":25,"email":25},"Christian Staackmann, Dr.",{"type":145,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[147,149],{"name":148,"class":6},"University of Southern Denmark",{"name":150,"class":6},"Medical School Hamburg","100553237","dermatitis-during-adjuvant-irradiation-for-breast-cancer-100553237",false,"NCT06483477","Dermatitis During Adjuvant Irradiation for BREAst Cancer:","Dermatitis During Adjuvant Irradiation for BREAst Cancer: Grade ≥2 Radiation Dermatitis in Breast Cancer Patients with or Without a Mobile Application (Reminder-App)","DAI-BREAC","Inclusion Criteria:\n\n1. Histologically proven invasive breast cancer\n2. Indication for adjuvant hypo-fractionated radiotherapy\n3. Possession of and ability to use a smartphone\n4. Female gender\n5. Age ≥18 years\n6. Written informed consent\n7. Capacity of the patient to contract\n\nExclusion Criteria:\n\n1. Pregnancy, Lactation\n2. Expected non-compliance","FEMALE","18 Years",{"count":162,"type":163},268,"ESTIMATED","INTERVENTIONAL",[166],"NA","In the randomized DAI-BREAC trial, a reminder app will be prospectively tested that reminds breast cancer patients four times each day to perform the required skin care. This will likely contribute to the reduction of grade ≥2 radiation dermatitis in these patients. A total of 268 patients will be randomized to receive standard skin care supported by a reminder app (Arm A) or standard skin care alone (Arm B). Stratification will be done using the three factors treatment volume, radiation boost, and at least one risk factor of dermatitis. Secondary aims include pain (radiation fields), patient satisfaction with the reminder app (Arm A only), impact of the app on the use of health technology (Arm A only), and benefit from support by staff members of the treating Department of Radiation Oncology and\u002For the UKSH academy regarding the use of the app (Arm A only).",[169],"Breast Cancer Female",[171,172,173,174],"Breast cancer","Radiotherapy","Dermatitis","Mobile application","2025-01-14",{"date":177,"type":178},"2025-01-16","ACTUAL",{"date":180,"type":178},"2024-12-23",{"date":182,"type":163},"2026-09-30",{"name":5,"class":6},5]