[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563239":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":97,"collaborators":100,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":19,"enrollmentInfo":123,"targetDuration":19,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":78,"whyStopped":19,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Implementation of home-based follow-up","EXPERIMENTAL","All patients within the PROMISE study are included in the 'experimental' arm. The study is set up as an implementation study, meaning that the home-based method of follow-up is applied to all patients in the study.",[13],"Other: Home-based follow-up",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Home-based follow-up","Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Dirk J. Grunhagen, MD, PhD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Elise M.H.E. van Driel, MD","CONTACT","+310107042125","m.h.e.vandriel@erasmusmc.nl",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"Lissa Wullaert, MD","0031 0107042125","l.wullaert@erasmusmc.nl",[35,52,65,77,88],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Amphia Hospital","NOT_YET_RECRUITING","Breda","North Brabant","4818CK","Netherlands","NL",{"type":44,"coordinates":45},"Point",[46,47],4.77596,51.58656,{"lat":47,"lon":46},[50],{"name":51,"role":27,"phone":19,"phoneExt":19,"email":19},"Paul Gobardhan, MD, PhD",{"facility":53,"status":37,"city":54,"state":55,"zip":56,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"IJsselland Hospital","Capelle aan den IJssel","South Holland","2906ZC",{"type":44,"coordinates":58},[59,60],4.57778,51.92917,{"lat":60,"lon":59},[63],{"name":64,"role":27,"phone":19,"phoneExt":19,"email":19},"Pascal Doornebosch, MD, PhD",{"facility":66,"status":37,"city":67,"state":55,"zip":68,"country":41,"countryCode":42,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Leiden University Medical Center","Leiden","2333ZA",{"type":44,"coordinates":70},[71,72],4.49306,52.15833,{"lat":72,"lon":71},[75],{"name":76,"role":27,"phone":19,"phoneExt":19,"email":19},"Koen C.M.J. Peeters, MD, PhD",{"facility":5,"status":78,"city":79,"state":55,"zip":80,"country":41,"countryCode":42,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"RECRUITING","Rotterdam","3015GD",{"type":44,"coordinates":82},[83,84],4.47917,51.9225,{"lat":84,"lon":83},[87],{"name":22,"role":27,"phone":19,"phoneExt":19,"email":19},{"facility":89,"status":78,"city":79,"state":55,"zip":90,"country":41,"countryCode":42,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Franciscus Gasthuis and Vlietland","3045PM",{"type":44,"coordinates":92},[83,84],{"lat":84,"lon":83},[95],{"name":96,"role":27,"phone":19,"phoneExt":19,"email":19},"Maria Verseveld, MD, PhD",{"type":23,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"D.J. (Dirk) Grünhagen","Surgical oncologist, MD, PhD",[101,104,106,108,109,111],{"name":102,"class":103},"Lifesignals Inc.","UNKNOWN",{"name":105,"class":103},"YourBio Health",{"name":107,"class":103},"TU Delft",{"name":36,"class":6},{"name":110,"class":103},"Leiden University Medical Center (LUMC)",{"name":112,"class":6},"Franciscus Gasthuis & Vlietland (Hospital)","100563239","patient-led-follow-up-from-home-after-surgery-for-colorectal-carcinoma-100563239",false,"NCT06613581","Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma","Patient-empowered Remote Oncology: the Prospective, Multicentre Implementation Study - the PROMISE","PROMISE","inclusion criteria\n\n* Age ≥ 21 years\n* Histologically confirmed colorectal adenocarcinoma without distant metastasis and treated with curative intent surgical resection less than 6 months ago\n* Scheduled or currently undergoing postoperative surveillance according to national guidelines\n* Written informed consent by the patient\n* Access to a smartphone\n\nExclusion criteria\n\n* Patients with a severely complicated postoperative course, needing in hospital follow- up longer than 6 months postoperatively\n* Patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging - yearly or more frequent - of the abdomen and\u002For thorax\n* Patients with comorbidity or other malignancy that requires imaging of the abdomen and\u002For thorax every year or more frequent\n* Patients with active implantable devices - e.g. pacemaker or implantable defibrillator\n* Inability to complete the questionnaires due to illiteracy and\u002For insufficient proficiency of the Dutch language","ALL","21 Years",{"count":124,"type":125},200,"ESTIMATED","INTERVENTIONAL",[128],"NA","The primary goal of the patient-led follow-up from home, is the improvement of quality of life and the reduction of stress in patients, while obtaining a more complete picture of their health status.\n\nA series of assessments are performed in the home setting:\n\n* Blood withdrawal for CEA determination\n* Quality of life questionnaires to assess both mental and physical symptoms\n* Vital parameters using a Smart Sensor",[131],"Colorectal Carcinoma (CRC)",[133,16,134,135,136,137],"Colorectal carcinoma","Patient-led","Capillary blood sampling","Biosensor","EORTC","2024-09-23",{"date":140,"type":141},"2024-09-26","ACTUAL",{"date":143,"type":141},"2024-07-18",{"date":145,"type":125},"2031-09",{"name":5,"class":6},5]