About this trial
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.
Eligibility criteria
Qualifiers
Age range: 7 years to 17 years, 11 months.
Received diagnosis and/or treatment/surveillance at GOSH for a childhood tumour that involved the CNS (brain) and/or oncology treatment to brain.
Received or receiving a neuropsychological assessment/consultation 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.
At least 6 months post-diagnosis/acute treatment (surgery and/or radiotherapy), and 3 months post-return to school, with stable disease.
Disqualifiers
Completed or having another targeted formal psychological intervention for cognitive rehabilitation or fatigue in the past 6 months.
Sensorimotor (e.g., visual-motor) impairment only on neuropsychological assessment without additional cognitive difficulty.
Current substance misuse from self-report.
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).
Trial design
Treatments tested in this trial
- THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Full intervention
- THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Cognitive rehabilitation only
Treatment groups
Sponsors and collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
Success Charity
Collaborator
Child Brain Injury Trust
Collaborator
Cambridge University Hospitals NHS Foundation Trust
Collaborator
The UCL Great Ormond Street Institute of Child Health
Collaborator
Nottingham University Hospitals NHS Trust
Collaborator