[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487445":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":49,"interventions":60,"overallOfficials":66,"centralContacts":78,"locations":86,"responsibleParty":102,"collaborators":105,"id":107,"slug":38,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":38,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":38,"enrollmentInfo":115,"targetDuration":38,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":88,"whyStopped":38,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Lovisenberg Diakonale Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"General Health literacy measured with the Health Literacy Questionnaire (HLQ)","Change of Health Literacy questionnaire","6 months, 9 months",[14,17,20,23,26,29,32,35],{"measure":15,"description":16,"timeFrame":12},"Electronic Health Literacy measured with the electronic Health Literacy Questionnaire (eHLQ)","Change of electronic Health Literacy questionnaire",{"measure":18,"description":19,"timeFrame":12},"General symptoms measured with the Edmonton Symptom Assessment System (ESAS)","Change of symptom burden questionnaire",{"measure":21,"description":22,"timeFrame":12},"Oral symptoms measured with four items selected from the European Organization for REsearch and Treatment of Cancer-oral health 15 (EORTC-OH 15)","Change in oral symptoms",{"measure":24,"description":25,"timeFrame":12},"Self-management measured with the Health Education Impact Questionnaire (HeiQ)","Change of self-management questionnaire",{"measure":27,"description":28,"timeFrame":12},"Self-Efficacy measured with the General Self-efficacy Scale (GSE)","Change of Self-efficacy questionnaire",{"measure":30,"description":31,"timeFrame":12},"Disease specific Quality of Life measured with the The functional Assessment of Cancer Therapy-General (FACT-G)","Change of quality of life questionnaire",{"measure":33,"description":34,"timeFrame":12},"Generic health-related quality of life\u002Fquality adjusted life years measured by the EQ-5D","Change in health related quality of life and adjusted life years",{"measure":36,"description":37,"timeFrame":12},"Health care costs measured through collecting data from patient medical records, patient self-report, and data registers","Change of health care costs",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","Randomized controlled trial","SUPPORTIVE_CARE",{"masking":45,"maskingDescription":46,"whoMasked":47},"SINGLE","The main researcher and PhD candidate will be blinded to the randomizing procedure. However, in this project, it is not feasible to blind the participants, HCPs or PhD candidate to the participants' group. The participants will be randomized right after the first assessment.",[48],"INVESTIGATOR",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"The Intervention Group","EXPERIMENTAL","The intervention group will receive a tailored intervention based on each individuals health literacy needs. A project nurse with broad experience in cancer care will be trained in Motivational Interviewing techniques to provide follow-up for the patients in the intervention group in a period of 9 months.",[55],"Behavioral: Tailored Health Literacy follow-up in cancer",{"label":57,"type":58,"description":59,"interventionNames":38},"Usual care group","NO_INTERVENTION","Usual care group will receive usual follow-up.",[61],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":38},"BEHAVIORAL","Tailored Health Literacy follow-up in cancer","1. Participants are invited to a consultation with the project nurse where the project nurse will use baseline data to identify the patient's HL needs, QOL, symptom burden and issues related to self-management of their cancer and treatment. These data will be used together with an interview questionnaire specifically developed to communicate HL needs (i.e. CHAT), which form the basis for the individualized HL support.\n2. Actions: Based on results of the consultation, the project nurse and the patient will use a worksheet of possible actions to identify those most relevant to the patient's individual needs. Based on this, different self-management tasks and actions will be offered, and an individual tailored follow-up plan will be made. The patient and the project nurse will use a workbook containing information on the follow-up plan that will be added into medical record.\n3. Telephone\u002Fdigital conversations with the project every second month for a period of 9 months.",[51],[67,71,75],{"name":68,"affiliation":69,"role":70},"Christine R Borge, PhD","Lovisenberg Diaconal Hospital and University of Oslo","PRINCIPAL_INVESTIGATOR",{"name":72,"affiliation":73,"role":74},"Astrid K Wahl, PhD","University of Oslo","STUDY_CHAIR",{"name":76,"affiliation":77,"role":74},"Simen A Steindal, PhD","VID",[79,83],{"name":68,"role":80,"phone":81,"phoneExt":38,"email":82},"CONTACT","+47 23225000","chrr@lds.no",{"name":84,"role":80,"phone":81,"phoneExt":38,"email":85},"Marit Leine, master","marit.leine@lds.no",[87],{"facility":5,"status":88,"city":89,"state":38,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"RECRUITING","Oslo","0440","Norway","NO",{"type":94,"coordinates":95},"Point",[96,97],10.74609,59.91273,{"lat":97,"lon":96},[100],{"name":101,"role":80,"phone":38,"phoneExt":38,"email":85},"Marit Leine",{"type":70,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Christine Råheim Borge","Researcher",[106],{"name":73,"class":6},"100487445",false,"NCT05627180","Tailored Health Literacy Follow-up in Cancer","Tailored Health Literacy Follow-up in Cancer - the Tail HealthLit Cancer Trial","Inclusion Criteria:\n\n* Diagnosed with cancer\n* Above 18 years old\n* Receiving treatment at the main intervention hospital\n\nExclusion Criteria:\n\n* Not diagnosed with cancer\n* Not above 18 years old\n* Not in treatment at the intervention hospital","ALL","18 Years",{"count":116,"type":117},150,"ESTIMATED","INTERVENTIONAL",[120],"NA","Health literacy refers to personal and relational factors affecting a persons ability to aquire, understand and use health information and health services. In a need assessment study, it was found that there is a need to focus on health literacy factors in the follow-up of people with cancer in the health care services.\n\nThus, this project evaluate the effect of a health literacy intervention in cancer. The intervention provides patients with nurse-led tailored follow-up by phone\u002Fdigital\u002Fpersonal meetings that addresses their individual HL needs, particularly those needs that impact their quality of life, symptom burden, self-management, and health economic costs. Our main goal is to improve the patients' health literacy, with secondary goals of improving their quality of life, symptom burden, and self-management, and reducing their health care costs.",[123],"Cancer",[125],"Health literacy","2023-03-30",{"date":128,"type":129},"2023-04-03","ACTUAL",{"date":126,"type":129},{"date":132,"type":117},"2026-12-31",{"name":5,"class":6},1]