[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575288":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":40,"locations":49,"responsibleParty":68,"collaborators":70,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":23,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":108,"overallStatus":118,"whyStopped":23,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Great Ormond Street Hospital for Children NHS Foundation Trust","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive rehabilitation with fatigue management","EXPERIMENTAL","A 12-week block of intervention (strategy-based cognitive rehabilitation with fatigue management)",[13],"Behavioral: THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Full intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Cognitive rehabilitation only","A 6-week block of intervention (strategy-based cognitive rehabilitation alone)",[18],"Behavioral: THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Cognitive rehabilitation only",{"label":20,"type":21,"description":22,"interventionNames":23},"Standard care","NO_INTERVENTION","Standard care only",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"BEHAVIORAL","THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Full intervention","A novel strategy-based cognitive rehabilitation intervention that can be delivered with or without cognitive fatigue management. Skills are targeted sequentially based on a developmental hierarchical model where cognitive fatigue can be addressed first, followed by adult-supported compensatory strategies, with independent use of strategies for specific impairments delivered only once these earlier levels have been addressed. The 'FLaME' program incorporates strategies that have been trialled and found successful in fatigue (e.g., pacing and activity scheduling) and cognitive rehabilitation (e.g., chunking, elaborative encoding techniques) interventions for children. The intervention address two key issues: 1) to deliver strategy-based cognitive rehabilitation as an alternative to prevailing drill-based approaches, and 2) to integrate fatigue management to improve feasibility and acceptability of cognitive rehabilitation. This arm include the full intervention.",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":23},"THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Cognitive rehabilitation only","A novel strategy-based cognitive rehabilitation intervention that can be delivered with or without cognitive fatigue management. Skills are targeted sequentially based on a developmental hierarchical model where cognitive fatigue can be addressed first, followed by adult-supported compensatory strategies, with independent use of strategies for specific impairments delivered only once these earlier levels have been addressed. The 'FLaME' program incorporates strategies that have been trialled and found successful in fatigue (e.g., pacing and activity scheduling) and cognitive rehabilitation (e.g., chunking, elaborative encoding techniques) interventions for children. The intervention address two key issues: 1) to deliver strategy-based cognitive rehabilitation as an alternative to prevailing drill-based approaches, and 2) to integrate fatigue management to improve feasibility and acceptability of cognitive rehabilitation. This arm includes the cognitive rehabilitation only.",[15],[35,38],{"name":36,"affiliation":5,"role":37},"Charlotte P Malcolm, DClinPsy","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Faraneh Vargha-Khadem, PhD",[41,46],{"name":36,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","+442074059200","0146","charlotte.malcolm@gosh.nhs.uk",{"name":47,"role":42,"phone":43,"phoneExt":44,"email":48},"Tara Murphy, DClinPsy","tara.murphy@gosh.nhs.uk",[50],{"facility":51,"status":23,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Great Ormond Street Hospital for Children","London","WC1N 3JH","United Kingdom","UK",{"type":57,"coordinates":58},"Point",[59,60],-0.12574,51.50853,{"lat":60,"lon":59},[63,65,66,67],{"name":36,"role":42,"phone":64,"phoneExt":44,"email":45},"+4402074059200",{"name":47,"role":42,"phone":43,"phoneExt":44,"email":48},{"name":36,"role":42,"phone":23,"phoneExt":23,"email":23},{"name":39,"role":42,"phone":23,"phoneExt":23,"email":23},{"type":69,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[71,74,77,79,81,83],{"name":72,"class":73},"National Institute for Health Research, United Kingdom","OTHER_GOV",{"name":75,"class":76},"Success Charity","UNKNOWN",{"name":78,"class":76},"Child Brain Injury Trust",{"name":80,"class":6},"Cambridge University Hospitals NHS Foundation Trust",{"name":82,"class":6},"The UCL Great Ormond Street Institute of Child Health",{"name":84,"class":6},"Nottingham University Hospitals NHS Trust","100575288","the-flame-cognitive-rehabilitation-study-for-childhood-brain-tumour-100575288",false,"NCT06770335","The FLaME Cognitive Rehabilitation Study for Childhood Brain Tumour","Strategy-based Cognitive Rehabilitation with Integrated Fatigue Management for Patients with Paediatric Brain Tumour (PBT): an Acceptability and Feasibility Study of the Fatigue, Learning and Memory Enrichment (FLaME) Intervention","FLaME","Inclusion Criteria:\n\n1. Age range: 7 years to 17 years, 11 months.\n2. Received diagnosis and\u002For treatment\u002Fsurveillance at GOSH for a childhood tumour that involved the CNS (brain) and\u002For oncology treatment to brain.\n3. Received or receiving a neuropsychological assessment\u002Fconsultation at GOSH over the course of the study period or in the 48 months prior to the study period, or under active surveillance with the neuro-oncology multidisciplinary team during the study period.\n4. At least 6 months post-diagnosis\u002Facute treatment (surgery and\u002For radiotherapy), and 3 months post-return to school, with stable disease.\n5. One or more scores outside of normal limits (i.e. 1 SD above or below the mean in the direction indicating difficulty) in at least one neuropsychological domain (on performance-based tests or questionnaire-based rating scales).\n6. Report impairment (z-score \\> -0.67) in fatigue on one or more subscales of the PedsQL Multidimensional Fatigue Scale.\n7. Capacity\u002Fcompetence of patient or parent\u002Fcarer to provide informed\n\nExclusion Criteria:\n\n1. Completed or having another targeted formal psychological intervention for cognitive rehabilitation or fatigue in the past 6 months.\n2. Sensorimotor (e.g., visual-motor) impairment only on neuropsychological assessment without additional cognitive difficulty.\n3. Current substance misuse from self-report.\n4. Currently receiving formal psychiatric care for a diagnosed mental health disorder (including active suicidal ideation), excluding ADHD treatment (if a child has a diagnosis of ADHD they should be treated).\n5. Intellectual Disability based on a standard score of more than 2 standard deviations below the mean on a general adaptive behaviour composite and, where available, the General Ability Index of intellect.\n6. Patient and parent\u002Fcarer is unable to communicate verbally and in written form in English.","ALL","7 Years","18 Years",{"count":97,"type":98},36,"ESTIMATED","INTERVENTIONAL",[101],"NA","Medical treatments have improved survival rates for children with brain tumours. However, most children experience long-term difficulties with 'cognition' (thinking skills such as memory and paying attention) and cognitive fatigue (excessive mental tiredness) after treatment. Thinking difficulties and fatigue can affect a child's ability to learn, and their social and emotional wellbeing. National guidance recommends treatment called 'cognitive rehabilitation' which teaches skills to improve or manage cognitive difficulties. Families often request this, but it is not usually available due to little research. Fatigue may also get in the way of children using and benefiting from cognitive rehabilitation. No research study has offered a fatigue treatment for children recovering from brain tumours. The study aims to see if it is practical and helpful to families to provide cognitive rehabilitation for children affected by brain tumours. The treatment focuses on strategies to help cognition. The investigators will see if adding strategies to manage fatigue helps. The study will include thirty-six 7-17-year-olds who have been treated for brain tumour at Great Ormond Street Hospital. All participants will have had an assessment describing cognitive strengths and weaknesses as part of usual care. Participants will be randomly allocated to one of three groups: 1) cognitive rehabilitation with fatigue management (12 weeks), 2) cognitive rehabilitation only (6 weeks), or 3) usual care. Each child and their carer will complete questionnaires before, during, and after the treatment, and an interview at the end of the treatment. This information will help the researchers see if families find the treatment helpful and practical to take part in, and if adding fatigue strategies is beneficial. Researchers will look at information such as the number of appointments attended, feedback about the treatment, and information about fatigue levels, cognition, and wellbeing. The findings will be used to develop a UK-wide study.",[104,105,106,107],"Childhood Brain Tumor","Childhood Brain Tumors","Pediatric Brain Neoplasms","Pediatric Brain Tumor",[109,110,111,112,113,114,115,116,117],"Paediatric brain tumour","cognitive rehabilitation","cognition","fatigue","feasibility","acceptability","neuropsychology","neurocognitive","childhood brain tumour","NOT_YET_RECRUITING","2025-01-07",{"date":121,"type":122},"2025-01-13","ACTUAL",{"date":124,"type":98},"2025-03-10",{"date":126,"type":98},"2026-12-31",{"name":5,"class":6},1]