The FLaME Rehabilitation Study for Childhood Brain Tumour V1.0
Research type
Research Study
Full title
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
IRAS ID
327316
Contact name
Charlotte Malcolm
Contact email
Sponsor organisation
Great Ormond Street Hospital for Children NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research 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 a rehabilitation treatment for children affected by brain tumours. The treatment focuses on strategies to help cognition. We will see if adding strategies to manage fatigue helps. We 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, thinking skills, and wellbeing. The findings will be used to develop a UK-wide study.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
24/LO/0844
Date of REC Opinion
11 Dec 2024
REC opinion
Favourable Opinion