[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100395788":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":34,"locations":42,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Göteborg University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","The child will firstly undergo phase A without the digital reporting and communication tool.\n\nThe child will secondly undergo phase B with the digital reporting and communication tool (i.e., A, B).",[13],"Device: Pictorial support in person-centred care for children (PicPecc)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2","The child will firstly undergo phase B with the digital reporting and communication tool.\n\nThe child will secondly undergo phase A without the digital reporting and communication tool (i.e., B, A).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Pictorial support in person-centred care for children (PicPecc)","Phase A: The child has the protocol for methotrexate treatment, the healthcare professionals have one workshop that containing person-centred care, universal design, distress, symptom management and the digital reporting and communication tool.\n\nPhase B: The child has everything in phase A. In addition, the child use the digital reporting and communication tool that has a thermometer (graded from zero (green) to ten (red)). The result of the assessment is visualized as a face (mimic and colour represents the intensity of the symptom and\u002For emotion (i.e., anxiety, appetite, fear\u002Fworries, how I´m feeling today, nausea, pain, sleep, and tiredness)). The digital reporting and communication tool has a body figure for location of pain, pictures for the type of pain, and an open question. There is an avatar and a gamification part, e.g., the child gets a pet after assessing the symptoms\u002Femotions. The child reports in the app, and the child decides the frequency of assessments.",[9,15],null,[26,30],{"name":27,"affiliation":28,"role":29},"Stefan Nilsson, PhD","Institute of Health and Care Sciences, University of Gothenburg, Sweden","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":33},"Jonas Bergquist, Professor","Dept of Chemistry Biomedical Centre, Uppsala University, Sweden","STUDY_DIRECTOR",[35,39],{"name":27,"role":36,"phone":37,"phoneExt":24,"email":38},"CONTACT","+46738538951","stefan.nilsson.4@gu.se",{"name":40,"role":36,"phone":24,"phoneExt":24,"email":41},"Joakim Öhlen, Professor","joakim.ohlen@fhs.gu.se",[43],{"facility":44,"status":45,"city":46,"state":24,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University of Gothenburg","RECRUITING","Gothenburg","40530","Sweden","SE",{"type":51,"coordinates":52},"Point",[53,54],11.96679,57.70716,{"lat":54,"lon":53},[57],{"name":27,"role":36,"phone":37,"phoneExt":24,"email":38},{"type":59,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[61],{"name":62,"class":63},"Swedish Childhood Cancer Fund","UNKNOWN","100395788","pictorial-support-in-person-centred-care-for-children-picpecc-100395788",false,"NCT04433650","Pictorial Support in Person-centred Care for Children (PicPecc)","A Person-centred Approach to Pictorial Support in Care for Children (PicPecc)","PicPecc","Inclusion Criteria:\n\n* Children with cancer, 5-17 years\n* The children´s legal guardians\n* Healthcare professionals who take care of these children\n* The child needs to have a cognitive level of approximately five years (i.e., be able to understand a numeric rating scale (NRS)).\n\nExclusion Criteria:\n\n\\- Children 0-4 years","ALL","5 Years","17 Years",{"count":76,"type":77},40,"ESTIMATED","INTERVENTIONAL",[80],"NA","Introduction: Person-centred care is based on the assumption that every person has resources that should be used in the care situation. In order for this to happen the patient has to be able to effectively communicate his\u002Fher symptoms. This protocol describes the analysis of a digital picture-based tool for communication support for children with cancer aged 5-17 years, who undergo high-dose methotrexate treatment. The advantage of a non-linguistic based platform, beside the expected clinical outcomes, is that it can be used in multiple national studies with minimal translation.\n\nMethods and analysis: Two studies will be conducted in a hybrid design, i.e., a crossover design will be used for the intervention (effects), and a mixed-methods design will be used for the process evaluation. Qualitative interviews will be carried out with children with cancer, their legal guardians and case-related healthcare professionals as part of the process evaluation.\n\nThe interviews will address the experiences of the intervention and frequency of use from the child's perspective. Interview transcripts will be analyzed qualitative descriptively. The digital communication tool will collect child self-reports of symptoms\u002Femotions. The children will be monitored for biomarkers of stress and pain (neuropeptides, neurosteroids and peripheral steroids) in venous blood samples, in-app estimation levels for the children, drug consumption. Person-centeredness will be evaluated with the questionnaire Visual CARE Measure.\n\nEthics: Ethical approval was obtained from the Swedish Ethical Review Authority (ref 2019-02392; 2020-02601).",[83,84,85],"Childhood Cancer","Communication","Symptoms and Signs",[87,84,88,89,90,85],"Childhood cancer","Digital application","Intervention","Pictorial support","2025-04-03",{"date":93,"type":94},"2025-04-06","ACTUAL",{"date":96,"type":94},"2021-04-01",{"date":98,"type":77},"2026-12-31",{"name":5,"class":6},1]