[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561390":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":88,"collaborators":90,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":31,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":57,"whyStopped":31,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"University Hospital of Ferrara","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual Reality-based Cognitive Remediation (VR-COG)","EXPERIMENTAL","Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as usual (TAU)\n\nThe \"VSail 3D\" experimental protocol includes scenarios (virtual environments) dedicated to the sport of sailing. It is based on the software CEREBRUM-VELA (Idego-Promind, srl, Rome, Italy).\n\nFrequency: 24 sessions, 2 times a week, for 12 consecutive weeks. The duration of each session is 50 minutes.",[13],"Device: Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU)",{"label":15,"type":10,"description":16,"interventionNames":17},"Repetitive transcranial magnetic stimulation (rTMS)","Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU)\n\nrTMS group will receive active rTMS using the MagVenture MagPro X100 System (MagVenture A\u002FS, Denmark) equipped with a MagVenture Cool-B65 A\u002FP double-faced coil and a neuronavigation system (Localite GmbH, Sankt Augustin, Germany).\n\nFrequency: 24 sessions, 2 times a week, for 12 consecutive weeks. The duration of each session is 60 minutes.",[18],"Device: Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU)",{"label":20,"type":21,"description":22,"interventionNames":23},"Treatment as Usual (TAU)","ACTIVE_COMPARATOR","Treatment as Usual (TAU)\n\nThe path, following the guidelines of the Italian Association of Medical Oncology (AIOM-SIPO: https:\u002F\u002Fwww.aiom.it), includes an initial psychiatric visit and eventual pharmacological therapy with psychiatric follow-up plus psychological counseling.\n\nFrequency: 12 weeks. Each counseling session lasts 45-50 minutes, and will be conducted on a monthly basis.",[24],"Other: Treatment as Usual (TAU)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU)","The \"CEREBRUM-VELA\" virtual reality software is made up of exercises designed to train different cognitive functions (i.e.: executive functions, motor ability, language). The different degrees of difficulty are designed to adapt to the user's functional diagnosis. Each session, after an initial part of welcome, psychoeducation and orientation to the instrument, involves alternating virtual reality exercises, positive and corrective feedback and suggestions of practical homework that the individual should try to do during his day.\n\nTreatment as usual (TAU) The path, following the guidelines of the Italian Association of Medical Oncology (AIOM-SIPO: https:\u002F\u002F www.aiom.it), includes an initial psychiatric visit aimed at assessing the presence of psychopathological conditions that may necessitate pharmacological therapy (antidepressants, hypnotic-sedatives) and subsequent psychiatric follow-up. The treatment also involves psychological counseling (monthly sessions).",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU)","Active rTMS stimulation will be delivered at 90% of the resting Motor Threshold (rMT), adjusted for the depth of the fcMRI-identified target. Personalized targets created for each individual will be located at various cortical depths. For safety reasons, the stimulation intensity will never exceed 120% of the rTMS.\n\nTreatment as usual (TAU) The path, following the guidelines of the Italian Association of Medical Oncology (AIOM-SIPO: https:\u002F\u002F www.aiom.it), includes an initial psychiatric visit aimed at assessing the presence of psychopathological conditions that may necessitate pharmacological therapy (antidepressants, hypnotic-sedatives) and subsequent psychiatric follow-up. The treatment also involves psychological counseling (monthly sessions).",[15],{"type":6,"name":20,"description":37,"armGroupLabels":38,"otherNames":31},"Treatment as usual (TAU) The path, following the guidelines of the Italian Association of Medical Oncology (AIOM-SIPO: https:\u002F\u002F www.aiom.it), includes an initial psychiatric visit aimed at assessing the presence of psychopathological conditions that may necessitate pharmacological therapy (antidepressants, hypnotic-sedatives) and subsequent psychiatric follow-up. The treatment also involves psychological counseling (monthly sessions).",[20],[40],{"name":41,"affiliation":42,"role":43},"Luigi Grassi, MD, PhD","Università degli Studi di Ferrara","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Martino Belvederi Murri, MD","CONTACT","00393335248720","martino.belvederimurri@unife.it",{"name":51,"role":47,"phone":52,"phoneExt":31,"email":53},"Barbara Zaccagnino, PsyD","00393288657355","barbara.zaccagnino@edu.unife.it",[55,74],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Health Trust, Ferrara","RECRUITING","Ferrara","FE","44124","Italy","IT",{"type":64,"coordinates":65},"Point",[66,67],11.62057,44.83804,{"lat":67,"lon":66},[70,72],{"name":46,"role":47,"phone":71,"phoneExt":31,"email":49},"0039 3335248720",{"name":51,"role":47,"phone":73,"phoneExt":31,"email":53},"0039 3288657355",{"facility":75,"status":57,"city":76,"state":31,"zip":77,"country":61,"countryCode":62,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"University Hospital of Cagliari","Cagliari","09124",{"type":64,"coordinates":79},[80,81],9.11917,39.23054,{"lat":81,"lon":80},[84],{"name":85,"role":47,"phone":86,"phoneExt":31,"email":87},"Federica Sancassiani, PsyD, PhD","0039 3493119215","federica.sancassiani@unica.it",{"type":89,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[91],{"name":75,"class":92},"UNKNOWN","100561390","non-pharmacological-care-for-depression-in-cancer-patients-using-vr-and-tms-100561390",false,"NCT06589544","Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS","Cost-effectiveness of Transcranial Magnetic Stimulation and Virtual Reality Based Cognitive Remediation on Depressive Symptoms Among Cancer Patients: a Three-arm Randomized Clinical Trial.","INCEPT","Inclusion Criteria:\n\n* Diagnosis of oncological disease in the last 5 years\n* Diagnosis of Major Depressive Disorder, without psychotic symptoms, according to DSM-5 criteria\n* 17-item Hamilton Rating Scale for Depression (HAM-D-17) (score ≥14)\n* Age: 18 years or older\n* Oncological disease in a non-advanced stage (Karnofsky Performance Status \\> 80)\n\nExclusion Criteria:\n\n* Current or prior hospitalization in the next 6 months\n* Planned surgery in the next 6 months\n* Suicidal ideation\n* Substance use\n* History of significant head trauma, neurological disorders, intellectual deficits\n* Recurrent seizures resulting from head trauma or conditions lowering seizure threshold\n* Concurrent use of medications that increase the risk of epileptic seizures (e.g., antipsychotics, tricyclics, theophylline)\n* Glaucoma, retinal detachment, or other serious vision impairments that may prevent the use of virtual reality technology\n* Severe problems with autonomous ambulation","ALL","18 Years","100 Years",{"count":105,"type":106},100,"ESTIMATED","INTERVENTIONAL",[109],"NA","Despite its significant impact on individuals and healthcare systems, substantial gaps remain in the clinical and rehabilitative management of depression in oncology patients.\n\nDepression in cancer patients is often under-recognized and untreated, and screening tools and structured healthcare pathways are lacking. Even when depression is identified in oncology patients, evidence of effective treatments is limited. There are no specific guidelines for psychotropic drug use in cancer patients, and antidepressant efficacy is uncertain despite their frequent use.\n\nEmerging strategies like transcranial magnetic stimulation and cognitive rehabilitation show promising findings. However, the cost-effectiveness of therapeutic strategies is understudied.\n\nRepetitive transcranial magnetic stimulation (rTMS) is already used for the treatment and relapse prevention of depression both as monotherapy and as an add-on to antidepressant pharmacotherapy, and it appears effective in improving cognitive performance. However, it has not yet been applied to treat depressive disorders in oncology patients.\n\nVirtual reality-based cognitive behavioral intervention (VR-COG) is designed to improve cognitive functioning, a central feature of depression in oncological conditions. VR-COG enhances learning and skill acquisition with better ecological efficiency than traditional cognitive remediation programs. VR approaches are well-received by oncology patients and show promise in reducing anxiety and depressive symptoms.\n\nThe trial aims to evaluate the effectiveness of highly specialized, nonpharmacological interventions on depressive symptoms and quality of life in oncology patients. Specifically, repetitive Transcranial Magnetic Stimulation (rTMS) and Virtual Reality-based Cognitive Remediation (VR-COG) will be analyzed, alongside standard Treatment as Usual (TAU), in comparison to TAU alone. This trial also aims at evaluate cognitive functioning, depression-related conditions and the cost-effectiveness of the interventions under study.",[112,113,114],"Depressive Symptoms","Quality of Life","Cognitive Impairment",[116,117,113,118,119,120],"Depression","Cognitive functions","Cancer","Virtual reality","Repetitive Transcranial Magnetic Stimulation","2024-09-09",{"date":123,"type":124},"2024-09-19","ACTUAL",{"date":126,"type":124},"2024-08-21",{"date":128,"type":106},"2027-12-31",{"name":5,"class":6},2]