[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575057":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":37,"responsibleParty":69,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":18,"enrollmentInfo":84,"targetDuration":18,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Those assigned to the intervention condition will start EMDR treatment immediately after enrolment. The intervention will consist of an intake (90 min) and a maximum of 4 EMDR sessions (90 min each). After inclusion, baseline characteristic (sociodemographic and clinical variables) will be assessed. Moreover, before start EMDR treatment, after the last EMDR session and 2 weeks- and 3 months after ending EMDR treatment FCR and quality of life will be assessed.",[13],"Other: eye movement desensitization and reprocessing (EMDR)",{"label":15,"type":16,"description":17,"interventionNames":18},"Waiting-list","NO_INTERVENTION","Those assigned to the waiting-list will wait for 6 weeks. After these 6 weeks those assigned to the waiting list condition are able to receive the same treatment and the same assessment schedule when FCR is still present.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"eye movement desensitization and reprocessing (EMDR)","EMDR is a psychological intervention that has historically been applied to the treatment of Post-Traumatic Stress Disorder (PTSD), but has since then been shown to be effective for a variety of anxiety disorders (e.g. fear of illness and specific phobia) (Logie \\& de Jongh, 2014) and somatic complaints such as post-operative pain, medically unexplained symptoms and seizure-related post-traumatic stress (Dautovic, de Roos, van Rood, Dommerholt, \\& Rodenburg, 2016; van Rood \\& de Roos, 2009; Maroufi, Zamani, Izadikhah, Marofi, \\& O'Connor, 2016).\n\nWith more than 25 randomized clinical trials, EMDR has been established as an evidence-based intervention for PTSD and PTSD symptomatology including physical symptoms and fear of future catastrophes (Balkom van et al., 2013).",[9],[25],{"name":26,"affiliation":27,"role":28},"Chris Hinnen, Dr.","Leiden University Medical Centre","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Sanne K. de Bie, Drs.","CONTACT","0031 71 526 3615","s.k.de_bie@lumc.nl",{"name":26,"role":32,"phone":33,"phoneExt":18,"email":36},"s.c.h.hinnen@lumc.nl",[38,55],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Leiden","South Holland","2333ZA","Netherlands","NL",{"type":46,"coordinates":47},"Point",[48,49],4.49306,52.15833,{"lat":49,"lon":48},[52],{"name":53,"role":32,"phone":18,"phoneExt":18,"email":54},"Sanne Bee","s.de_bie@lumc.nl",{"facility":27,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},{"type":46,"coordinates":57},[48,49],{"lat":49,"lon":48},[60,64,66,67],{"name":61,"role":32,"phone":62,"phoneExt":18,"email":63},"Sanne K. de Bie, drs.","(+31) 071 526 3615","fame.studie@lumc.nl",{"name":61,"role":32,"phone":65,"phoneExt":18,"email":34},"(+31) 0616658186",{"name":61,"role":32,"phone":18,"phoneExt":18,"email":18},{"name":68,"role":32,"phone":18,"phoneExt":18,"email":18},"Chris Hinnen, dr.",{"type":28,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"schhinnen","dr. Chris (S.C.H.) Hinnen, Principal Investigator, Clinical Psychologist",[73],{"name":74,"class":6},"Erasmus Medical Center","100575057","emdr-for-fear-of-cancer-recurrence-in-patients-with-familial-melanoma-a-waiting-list-control-trial-100575057",false,"NCT06767332","EMDR for Fear of Cancer Recurrence in Patients with Familial Melanoma: a Waiting List Control Trial","FAME","Inclusion Criteria:\n\n* a score of 16 or higher on the FCRI-NL-SF\n* 18 years or older\n* diagnosed with familial melanoma\n\nExclusion Criteria:\n\n* insufficient knowledge of the Dutch language.\n* acute psychiatric disease (psychosis, suicidal ideation)\n* variable dosis of anxiolytics","ALL","18 Years",{"count":85,"type":86},30,"ESTIMATED","INTERVENTIONAL",[89],"NA","High fear of cancer recurrence (FCR) impacts patient's quality of life (QoL) and is prevalent among patients with familial melanoma. The main objective is to investigate whether EMDR is effective in treating high FCR in patients with familial melanoma. The study design is a non-blinded, randomized waiting-list controlled trial. Patients aged 18 years or older with familial melanoma can be included. Patients with high FCR will receive a maximum of 4, 90 minutes, EMDR-sessions. The main study parameter is the decrease and level of FCR measured with the Cancer Worry Scale (CWS). The secondary study parameter is quality of life, measured with the EORTC.",[92,93,94,95],"Familial Melanoma","Fear of Cancer Recurrence","Eye Movement Desensitization and Reprocessing","Psychological Intervention",[97,93,92,94,98,99,100,101],"EMDR","Psychological intervention","Anxiety","Psycho-oncology","FCR","2025-01-08",{"date":104,"type":105},"2025-01-09","ACTUAL",{"date":107,"type":105},"2023-11-01",{"date":109,"type":86},"2025-12-31",{"name":5,"class":6},2]