[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-brain-tumour\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-brain-tumour":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100625762","ot-smile-occupational-therapy-group-intervention-for-primary-brain-tumour-patients-100625762",false,"NCT07426848","OT SMILE: Occupational Therapy Group Intervention for Primary Brain Tumour Patients","Occupational Therapy Symptom Management Through Innovative Lifestyle Engagement (OT SMILE): A Randomised Controlled Trial in Patients With Primary Brain Tumours","OTSMILE","Inclusion Criteria:\n\nAge ≥ 18 years Diagnosis of primary brain tumour Currently receiving systemic anti-cancer treatment (SACT) Experiencing difficulty with occupational performance (self-reported or clinician-identified) Sufficient cognitive and communication ability to participate in group sessions (assessed clinically and\u002For via screening tool) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Able to provide written informed consent\n\nExclusion Criteria:\n\nECOG performance status ≥ 3 Current inpatient status Major depressive episode or significant psychiatric condition preventing participation in group sessions Significant language barrier preventing participation in English-language sessions\n\nInability to provide informed consent\n\n\\-","ALL","18 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"NA","People diagnosed with primary brain tumours often experience significant symptoms such as fatigue, cognitive changes, anxiety, and reduced ability to carry out everyday activities. These symptoms may be related to the tumour itself or to ongoing systemic anti-cancer treatment. In Ireland, access to structured rehabilitation and symptom management programmes for this population is limited.\n\nThe OT SMILE study is evaluating whether a structured occupational therapy-led group programme can improve quality of life and daily functioning in adults with primary brain tumours receiving active treatment.\n\nParticipants attending Beaumont Hospital who meet eligibility criteria and provide informed consent will be randomly assigned (like flipping a coin) to one of two groups:\n\nA six-week occupational therapy group programme (OT SMILE), or\n\nUsual care, consisting of written lifestyle management information.\n\nThe OT SMILE programme consists of six weekly 90-minute group sessions delivered by occupational therapists. Sessions focus on fatigue management, activity modification, cognitive strategies, relaxation techniques, goal setting, exercise, nutrition, and peer support.\n\nParticipants in both groups will complete questionnaires before the programme begins and again after six weeks. These questionnaires measure quality of life, fatigue, and daily functioning.\n\nThe main goal of the study is to determine whether the occupational therapy group programme improves health-related quality of life compared to usual care. The results may help inform supportive care services for people living with primary brain tumours.",[27,28,29],"Primary Brain Tumour","Glioblastoma","Brain Neoplasms",[31,32,33,34,35,36,37,38],"Occupational Therapy","Symptom Management","Brain Cancer","Neuro-Oncology","Supportive Care","Rehabilitation","Health Related Quality of Life","FACT-BR","RECRUITING","2026-02-16",{"date":42,"type":43},"2026-02-23","ACTUAL",{"date":45,"type":43},"2025-12-18",{"date":47,"type":21},"2028-12-31",{"name":49,"class":50},"Royal College of Surgeons, Ireland","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100386031","cognitive-function-after-radiation-therapy-for-primary-brain-tumours-100386031","NCT04306432","Cognitive Function After Radiation Therapy for Primary Brain Tumours","Inclusion Criteria:\n\n* 18 years or older and Danish speaking.\n* Performance status WHO 0-2\n* Capable of cooperating on testing\n* Tumour histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligodendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas\n\nExclusion Criteria:\n\n* Glioblastoma\n* Performance status 3-4 (Karnofsky Performances of 60 or less)",true,"100 Years",{"count":61,"type":21},300,"OBSERVATIONAL","This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. All types of brain tumours apart from glioblastoma will be included.",[27,65,66],"Radiation Toxicity","Cognitive Impairment",[68,69,70,71,72],"Brain tumour","Radiation therapy","Cognitive function","Hippocampus","Patient reported outcomes","2021-11-19",{"date":75,"type":43},"2021-12-02",{"date":77,"type":43},"2019-01-03",{"date":79,"type":21},"2034-03-31",{"name":81,"class":50},"University of Aarhus",5]