[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653457":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":32,"interventions":41,"overallOfficials":25,"centralContacts":50,"locations":59,"responsibleParty":176,"collaborators":179,"id":189,"slug":190,"hasResults":191,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":197,"sex":198,"minAge":199,"maxAge":25,"enrollmentInfo":200,"targetDuration":25,"studyType":203,"phases":204,"briefSummary":206,"conditions":207,"keywords":25,"overallStatus":93,"whyStopped":25,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},{"fullName":5,"class":6},"University of Regensburg","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Functioning, 17 items (EORTC QLQ-F17)","Quality of life of patient and support person is obtained using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Functioning, 17 items (EORTC QLQ-F17). Scores range from 0 to 100, with higher scores indicating better functioning\u002Fquality of life.","From enrollment to the use of treatment at 4 weeks, 3 months, 6 months and 12 months",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Cancer Behavior Inventory Brief Version (CBI-B-D-12)","Self-efficacy is measured as secondary outcome using the Cancer Behavior Inventory Brief Version (CBI-B-D-12), with total scores ranging from 12 to 108, where higher scores indicate greater self-efficacy.","From enrollment to the use of treatment at 4 weeks and 3,6 and 12 months",{"measure":19,"description":20,"timeFrame":17},"self-developed items on knowledge of health and care","Knowledge of health and care is measured as a secondary outcome using self-developed items. Items were developed based on a literature review, and were reviewed, refined, and pilot-tested with the PRISMA Patient Advisory Board.",{"measure":22,"description":23,"timeFrame":24},"Healthcare Utilization (Care Level, Hospital Admissions, Length of Stay, Supportive Care Services)","Healthcare utilization will be assessed by patients' need for long-term care (care level), number of hospital admissions and length of hospital stays (both obtained from hospital records), and documentation of supportive care services (assessed using self-developed items based on standardized instruments).","From enrollment to the use of treatment at 4 weeks and 3, 6 and 12 months",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE",[33,38],{"label":34,"type":35,"description":25,"interventionNames":36},"intervention","EXPERIMENTAL",[37],"Other: PRISMA-interventions",{"label":39,"type":40,"description":25,"interventionNames":25},"control","NO_INTERVENTION",[42],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"PRISMA-interventions","A multicomponent intervention including social prescriptions, web-based micro-learning modules, and stepwise care based on symptom monitoring.",[34],[47,48,49],"Social prescription","Micro-learning","Monitoring (stepwise care)",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":25,"email":55},"Anne Herrmann, Prof. Dr.","CONTACT","+49 941 944 5220","Anne.Herrmann@ur.de",{"name":57,"role":53,"phone":25,"phoneExt":25,"email":58},"Hansjoerg Baurecht, Dr.","Hansjoerg.Baurecht@ur.de",[60,78,91,120,126,141,149,164],{"facility":61,"status":62,"city":63,"state":64,"zip":25,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"University Hospital Augsburg","NOT_YET_RECRUITING","Augsburg","Bavaria","Germany","DE",{"type":68,"coordinates":69},"Point",[70,71],10.89851,48.37154,{"lat":71,"lon":70},[74],{"name":75,"role":53,"phone":76,"phoneExt":25,"email":77},"Nina Ditsch, Prof Dr","+49 821 400-01","nina.ditsch@uk-augsburg.de",{"facility":79,"status":62,"city":80,"state":64,"zip":25,"country":65,"countryCode":66,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"University Hospital Erlangen","Erlangen",{"type":68,"coordinates":82},[83,84],11.00783,49.59099,{"lat":84,"lon":83},[87],{"name":88,"role":53,"phone":89,"phoneExt":25,"email":90},"Andreas Mackensen, Prof Dr","+49 913185-35954","med5-direktion@uk-erlangen.de",{"facility":92,"status":93,"city":94,"state":64,"zip":95,"country":65,"countryCode":66,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"University Hospital Regensburg","RECRUITING","Regensburg","93053",{"type":68,"coordinates":97},[98,99],12.10161,49.01513,{"lat":99,"lon":98},[102,106,109,111,114,116,118],{"name":103,"role":53,"phone":104,"phoneExt":25,"email":105},"Wolfgang Herr, Prof Dr","+49 941 944-5501","wolfgang.herr@ukr.de",{"name":107,"role":108,"phone":25,"phoneExt":25,"email":25},"Tobias Pukrop, Prof Dr","PRINCIPAL_INVESTIGATOR",{"name":110,"role":108,"phone":25,"phoneExt":25,"email":25},"Daniel Heudobler, Prof Dr",{"name":112,"role":113,"phone":25,"phoneExt":25,"email":25},"Daniel Wolff, Prof Dr","SUB_INVESTIGATOR",{"name":115,"role":113,"phone":25,"phoneExt":25,"email":25},"Kathrin Reuthner",{"name":117,"role":113,"phone":25,"phoneExt":25,"email":25},"Michael Koller, Prof Dr",{"name":119,"role":113,"phone":25,"phoneExt":25,"email":25},"Florian Zeman",{"facility":121,"status":122,"city":94,"state":64,"zip":95,"country":65,"countryCode":66,"cosmosGeoPoint":123,"geoPoint":125,"contacts":25},"University Regensburg","ACTIVE_NOT_RECRUITING",{"type":68,"coordinates":124},[98,99],{"lat":99,"lon":98},{"facility":127,"status":62,"city":128,"state":64,"zip":25,"country":65,"countryCode":66,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"University Hospital Würzburg","Würzburg",{"type":68,"coordinates":130},[131,132],9.95121,49.79391,{"lat":132,"lon":131},[135,139],{"name":136,"role":53,"phone":137,"phoneExt":25,"email":138},"Hermann Einsele, Prof Dr","+49 931 201-40001","einsele_h@ukw.de",{"name":140,"role":108,"phone":25,"phoneExt":25,"email":25},"Imad Maatouk, Prof Dr",{"facility":142,"status":122,"city":143,"state":25,"zip":25,"country":65,"countryCode":66,"cosmosGeoPoint":144,"geoPoint":148,"contacts":25},"Faculty of Law, Business & Economics, Inst. for Healthcare Management & Health Sciences","Bayreuth",{"type":68,"coordinates":145},[146,147],11.57893,49.94782,{"lat":147,"lon":146},{"facility":150,"status":62,"city":151,"state":25,"zip":25,"country":65,"countryCode":66,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Charité - University Medicine Berlin","Berlin",{"type":68,"coordinates":153},[154,155],13.41053,52.52437,{"lat":155,"lon":154},[158,162],{"name":159,"role":53,"phone":160,"phoneExt":25,"email":161},"Ulrich Keller, Prof Dr","+49 30 450 513 382","ulrich.keller@charite.de",{"name":163,"role":108,"phone":25,"phoneExt":25,"email":25},"Susanne Rittig, Dr",{"facility":165,"status":62,"city":166,"state":25,"zip":25,"country":65,"countryCode":66,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"University Hospital Köln","Cologne",{"type":68,"coordinates":168},[169,170],6.95,50.93333,{"lat":170,"lon":169},[173],{"name":174,"role":53,"phone":25,"phoneExt":25,"email":175},"Freerk Baumann, Prof Dr","freerk.baumann@uk-koeln.de",{"type":108,"investigatorFullName":177,"investigatorTitle":178,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Anne Herrmann","Prof. Dr.",[180,182,183,185,186,187],{"name":181,"class":6},"Universitätsklinikum Köln",{"name":79,"class":6},{"name":184,"class":6},"Wuerzburg University Hospital",{"name":61,"class":6},{"name":92,"class":6},{"name":188,"class":6},"Charite University, Berlin, Germany","100653457","social-prescriptions-and-micro-learning-to-improve-care-for-cancer-patients-and-their-support-persons-100653457",false,"NCT07788729","Social Prescriptions and Micro-Learning to Improve Care for Cancer Patients and Their Support Persons","PRISMA - A Pilot Randomized Phase II Trial on Social Prescriptions and Micro- Learning to Improve Care for Cancer Patients and Their Support Persons","PRISMA","Inclusion Criteria for patients:\n\n* aged at least 18 years\n* primary diagnosis of early-stage or advanced-stage lung cancer, colorectal cancer, hematological neoplasm or malignant melanoma within the past 12 months\n* expected survival of at least 18 months\n* sufficient German language proficiency to complete questionnaires and interviews\n* attendance at the medical oncology units of participating hospitals\n* provision of written informed consent\n* ECOG Performance Status 0-2\n* ability to name an eligible SP.\n\nInclusion criteria for Support Persons:\n\n* being nominated by the patient as someone who provides support, encouragement or assistance in coping with their cancer\n* aged at least 18 years\n* proficiency in German\n* provision of written informed consent.\n\nExclusion Criteria:\n\nInability to\n\n* provide informed consent\n* independently complete interviews and\u002For questionnaires due to impaired speech, vigilance, or comprehension.",true,"ALL","18 Years",{"count":201,"type":202},384,"ESTIMATED","INTERVENTIONAL",[205],"NA","Optimal patient-centered care is often not being delivered to cancer patients, especially to vulnerable populations like those living in underserved rural areas. This body of work will develop and pilot test a multicomponent intervention approach designed to improve the care and outcomes of cancer patients and their support persons (SPs) during and following their therapeutic journey. The intervention will involve the provision of social prescriptions and web-based micro-learning modules, as well as stepwise care based on ongoing monitoring of symptom burden and health. This project uses the strengths of innovative, individually tailored communication strategies and a comprehensive low-cost approach that are likely to support fair and equal patient access to optimal care beyond the funding period. By using a patient-driven approach in an interdisciplinary setting, it is anticipated that the intervention will improve the health outcomes of various patient populations, especially those living in rural areas. To achieve this, a methodologically robust mixed-methods approach and an effectiveness-implementation hybrid design will be employed to move effective strategies towards implementation into clinical practice. A number of standardized patient-reported outcome and experience measures will be used, including quality of life and knowledge of health and care. As a result of this research, an implementation toolbox will be developed that could be used by clinicians working in different healthcare settings and services, both nationally and internationally, to help provide highest quality cancer care.",[208,209,210,211,212],"Cancer","Lung Cancer","Colorectal Cancer","Hematological Cancer","Malignant Melanoma","2026-08-24",{"date":215,"type":216},"2026-08-26","ACTUAL",{"date":218,"type":216},"2026-04-21",{"date":220,"type":202},"2028-11-30",{"name":5,"class":6},8]