[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100409467":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":55,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":18,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":18,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Herlev Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","The intervention will be comprised of providing patients with supportive application with integrated PRO consisting of:\n\n* Weekly self-reporting of PRO-CTCAE with integrated preparation questionnaire available for staff\n* Daily monitoring of self-reporting by study staff\n* Intervention if required based on self-reporting\n* Reports to oncologists (at consultation)\n* Information module about treatment, side effects and contact information",[13],"Other: Supportive application with integrated weekly PRO",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Arm","NO_INTERVENTION","Standard care for patients will be included in no-intervention arm will consist of the standard procedures at Herlev Hospital, Department of Oncology for monitoring and documenting symptoms, which will be typical of oncology practice. Symptoms will be discussed and documented in the medical record during clinical encounters between patients and their oncologists. Patients will be encouraged to initiate telephone contact between visits for concerning symptoms, i.e. \"call early and often\".",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Supportive application with integrated weekly PRO","Patients will fill in a web-based application PRO-CTCAE with integrated preparation questionnaire every week. If their weekly reported symptoms exceed a predefined threshold of severity, this results in a notification on the staff application interface and a nurse will contact a patient for verification of symptoms. Nurse will review patient recent treatment and PRO reports and advise patient according to the local practice for symptom management and reinforce reporting. Nurse will consult with or refers to (if possible) treating physician if patient will require medical intervention and\u002For physician assistance.",[9],[25],{"name":26,"affiliation":27,"role":28},"Inna M Chen, MD","Herlev and Gentofte Hospital","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+45 38682898","Inna.Chen@regionh.dk",[35],{"facility":36,"status":37,"city":38,"state":18,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Herlev & Gentofte University Hospital, Denmark","RECRUITING","Herlev","2730","Denmark","DK",{"type":43,"coordinates":44},"Point",[45,46],12.43998,55.72366,{"lat":46,"lon":45},[49,51],{"name":50,"role":31,"phone":32,"phoneExt":18,"email":33},"Inna Chen, MD",{"name":52,"role":31,"phone":53,"phoneExt":18,"email":54},"Dorte Nielsen, MD DMSc","+45 38682344","Dorte.Nielsen.01@regionh.dk",{"type":56,"investigatorFullName":50,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","MD",[59],{"name":60,"class":61},"Roche Pharma AG","INDUSTRY","100409467","study-of-pro-in-patients-with-advanced-pancreatic-or-biliary-tract-cancer-bettereveryday-100409467",false,"NCT04611867","Study of PRO in Patients with Advanced Pancreatic or Biliary Tract Cancer (BetterEveryDay)","Study of Supportive Application with Integrated Patient-Reported Outcomes in Patients with Advanced Pancreatic or BiliaryTract Cancer (BetterEveryDay)","BetterEveryDay","Inclusion Criteria:\n\n* Adult (aged 18 and over)\n* Confirmed by cytology or histology advanced lung (NSCLC) or pancreatic cancer\n* Written informed consent before any study procedures\n* Planning to receive 1st line systemic anticancer therapy within ≤2 weeks\n* Performance status: ECOG 0-2\n* Access to the internet\n* Ability to read and respond to questions or able to complete questions with minimal assistance required from an interpreter or family member\n\nExclusion Criteria:\n\n* No mobile device\n* Exhibiting signs of overt psychopathology or cognitive dysfunction\n* Any medical condition that the Investigator considers significant to compromise the safety of the patient or that impairs the interpretation of study assessments\n* Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention. Participation in protocols related only to treatment will not preclude participation in the present study. Cases of doubt will be settled by the protocol responsible.","ALL","18 Years",{"count":73,"type":74},274,"ESTIMATED","INTERVENTIONAL",[77],"NA","Pancreatic and biliary tract cancer are ones of the leading causes of cancer-related deaths. During the course of illness, these patients often experience marked physical suffering, psychological distress and frequent unplanned resource-demanding hospitalized care. Patients with pancreatic and lung cancer have highest rates of unplanned hospitalizations. Investigator initiated prospective \"Study of Supportive Application with Integrated Patient-Reported Outcomes in Patients with Advanced Pancreatic or Biliary Tract Cancer (BetterEveryDay)\" is to be initiated based on the great need for optimizing treatment care, reducing hospitalizations and improving outcomes.",[80,81],"Pancreatic Cancer","Lung Cancer, Nonsmall Cell","2024-09-30",{"date":84,"type":85},"2024-10-02","ACTUAL",{"date":87,"type":85},"2021-08-17",{"date":89,"type":74},"2027-04-01",{"name":50,"class":6},1]