[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625762":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Royal College of Surgeons, Ireland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Lifestyle Management Literature (Control)","ACTIVE_COMPARATOR","Participants receive standard written lifestyle management information regarding symptom management and self-care strategies and continue usual oncology care. No structured group intervention is provided.",[13],"Other: Standard Lifestyle Management Literature",{"label":15,"type":16,"description":17,"interventionNames":18},"OT SMILE Occupational Therapy Group Intervention","EXPERIMENTAL","Participants receive a structured six-week occupational therapy-led group intervention in addition to usual oncology care. The programme consists of six weekly 90-minute sessions delivered in small groups (6-8 participants per cohort).",[19],"Behavioral: OT SMILE Occupational Therapy Group Programme",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Standard Lifestyle Management Literature","Provision of written educational materials addressing symptom management, fatigue, activity pacing, and lifestyle strategies. Participants continue routine oncology care without structured occupational therapy group sessions.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"BEHAVIORAL","OT SMILE Occupational Therapy Group Programme","A structured six-week group-based occupational therapy programme delivered by registered occupational therapists. Sessions include fatigue management strategies, goal setting, activity pacing, cognitive strategies, relaxation techniques, exercise guidance, nutrition education, peer support, and strategies to support long-term self-management. Each session lasts approximately 90 minutes and is delivered weekly.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Caoilfhionn O Donovan","CONTACT","+35318093000","caoilfhionnodonovan@rcsi.ie",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Beaumont RCSI Cancer Centre","RECRUITING","Dublin","Beaumont","D09V2N0","Ireland","IE",{"type":47,"coordinates":48},"Point",[49,50],-6.24889,53.33306,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":25,"email":56},"Aisling Hegarty, PhD","018093000","Aislinghegarty@rcsi.ie",{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":70,"type":71},96,"ESTIMATED","INTERVENTIONAL",[74],"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.",[77,78,79],"Primary Brain Tumour","Glioblastoma","Brain Neoplasms",[81,82,83,84,85,86,87,88],"Occupational Therapy","Symptom Management","Brain Cancer","Neuro-Oncology","Supportive Care","Rehabilitation","Health Related Quality of Life","FACT-BR","2026-02-16",{"date":91,"type":92},"2026-02-23","ACTUAL",{"date":94,"type":92},"2025-12-18",{"date":96,"type":71},"2028-12-31",{"name":5,"class":6},1]