[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458765":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":53,"collaborators":57,"id":60,"slug":18,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Herlev and Gentofte Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Patients in the intervention arm will receive follow-up conducted by melanoma nurses, where the patients will get tools to cope with the melanoma diagnosis and structured training in skin self-examination",[13],"Other: The MelaCare intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Patients in the control arm will receive clinical follow-up according to the current standard of care for their clinical stage.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"The MelaCare intervention","The primary principles applied will be:\n\n* Meta-cognitive strategies and normalization of emotions\n* Self efficacy related to SSE and knowledge on when to seek a doctor for clinical examination\n\nThe intervention will include 4 components:\n\n* An educational booklet\n* Doctor consultation to ensure correct SSE skills and compliance to the protocol\n* 3-5 sessions with a experienced and specially trained melanoma nurse\n* Use of patients' answers from the Patient Reported Outcome 'Functional Assessment of Cancer Treatment - Melanoma' (FACT-M) at the nurse sessions to address current emotional and\u002For physical sequelae.",[9],[25],{"name":26,"affiliation":5,"role":27},"Lisbet R Hölmich, Professor","STUDY_CHAIR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Sara M Hansen, MD","CONTACT","+4538681296","sara.moelgaard.hansen@regionh.dk",{"name":26,"role":31,"phone":35,"phoneExt":18,"email":36},"+4538681243","lisbet.rosenkrantz.hoelmich@regionh.dk",[38],{"facility":5,"status":39,"city":40,"state":18,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Copenhagen","2730","Denmark","DK",{"type":45,"coordinates":46},"Point",[47,48],12.56553,55.67594,{"lat":48,"lon":47},[51,52],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":26,"role":31,"phone":35,"phoneExt":18,"email":36},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Sara Molgaard Hansen","Principal investigator",[58],{"name":59,"class":6},"Danish Cancer Society","100458765",false,"NCT05253872","The MELAcare Study: A New Method for Surveillance of Melanoma Patients","The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients","Inclusion Criteria:\n\n* Ability to read and understand Danish language\n* Willing and able to give written informed consent\n* Surgical treatment of a clinical stage IA-IIA melanoma within 3 months of inclusion\n\nExclusion Criteria:\n\n* Advanced melanoma, clinical stages IIB, IIC, III, or IV\n* Patients with high risk of a new primary melanoma (dysplastic nevus syndrome, or family history of melanoma)\n* History of melanoma skin cancer prior to the index diagnosis\n* Previous cancer, excluding non-melanoma skin cancer\n* Comorbidity that makes skin self-examination impossible (e.g. physical or mental disabilities, dementia or decreased cognitive function)\n* non-detection of sentinel node in IB and IIA patients","ALL","18 Years",{"count":69,"type":70},378,"ESTIMATED","INTERVENTIONAL",[73],"NA","The aim of this study is to evaluate a new method of follow-up for patients with low and intermediate risk (stages IA-IIA) melanoma. The investigators will compare different tools for patient support and education combined with clinician supported skin self-examination (SSE) to the current standard-of-care. The hypothesis is that meta-cognitive strategies and clinician supported SSE can lower fear of cancer recurrence (FCR) and promote effective SSE on a regular basis without compromising the detection of new primary melanomas and\u002For metastases.",[76],"Cutaneous Melanoma",[78,79,80,81,82],"cutaneous melanoma","follow-up","nurse-led follow-up","skin self-examination","survivorship","2023-06-23",{"date":85,"type":86},"2023-06-26","ACTUAL",{"date":88,"type":86},"2022-03-09",{"date":90,"type":70},"2028-03",{"name":5,"class":6},1]