Clinical Trial

The FLaME Cognitive Rehabilitation Study for Childhood Brain Tumour

Study acronym: FLaME
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT06770335
Lead Sponsor Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators: National Institute for Health Research, United Kingdom, Success Charity, Child Brain Injury Trust, Cambridge University Hospitals NHS Foundation Trust, The UCL Great Ormond Street Institute of Child Health, Nottingham University Hospitals NHS Trust
Conditions Childhood Brain Tumor, Childhood Brain Tumors, Pediatric Brain Neoplasms, Pediatric Brain Tumor
Enrollment 36 participants
Start Date 2025-03-10
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-01-13