Strategy-based cognitive rehabilitation for childhood brain tumour: Protocol for an acceptability and feasibility trial of the Fatigue, Learning, and Memory Enrichment (FLaME) intervention.

Background: Medical treatments have improved survival rates for paediatric brain tumour (PBT), but the condition and treatment continue to be associated with significant cognitive morbidity. Nearly all survivors will experience some degree of cognitive impairment (neurocognitive 'late effects') that has a cascading impact on the development of intellectual and academic skills, quality of life, mental health, vocational attainment, and functional independence. Longstanding cognitive fatigue is also a prevalent symptom for survivors of PBT and further impacts engagement with therapeutic interventions and quality of life. Cognitive rehabilitation is recommended in national healthcare guidance and frequently requested by patients and families but rarely implemented due to a limited evidence base and poor feasibility and acceptability. There are currently no therapeutic interventions for cognitive fatigue for PBT survivors.

Aims & objectives: We aim to establish feasibility, acceptability, and preliminary efficacy for strategy-based cognitive rehabilitation for PBT. The study will determine if there is benefit to feasibility and acceptability when cognitive fatigue management is integrated to cognitive rehabilitation.

Methods: Thirty-six 7-17 years olds diagnosed with PBT will be recruited from Great Ormond Street Hospital. Participants will be randomised to either 1) a 12-week cognitive rehabilitation intervention with integrated cognitive fatigue management, 2) a 6-week cognitive rehabilitation intervention alone, or 3) standard care. All participants will have received neuropsychological assessment identifying difficulties with cognition and fatigue. Feasibility (e.g., attrition, retention, adherence) will be assessed through the trial. Acceptability will be measured throughout using questionnaires and interviews based on the Theoretical Framework for Acceptability and satisfaction rating scale. Preliminary effectiveness data will be gathered pre- and post-intervention using standardised measures of cognitive skills, fatigue, quality of life, % school attendance, and goal-based outcomes.

Outcome: The findings will be used to determine the appropriate rehabilitation intervention for a larger, multicentre randomised controlled trial.