The FLaME Cognitive Rehabilitation Study for Childhood Brain Tumour

Launched by GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST · Jan 7, 2025

Keywords

ClinConnect Summary

The FLaME Cognitive Rehabilitation Study is looking at how to help children aged 7 to 17 who have been treated for brain tumors. While medical treatments have improved survival rates, many children face ongoing challenges with thinking skills, like remembering things and focusing, as well as feelings of mental tiredness, known as cognitive fatigue. This study will explore whether a program called cognitive rehabilitation, which teaches strategies to improve thinking skills, is helpful for these children. It will also see if adding strategies to manage fatigue can make the program even more effective.

To participate, children must have been diagnosed and treated for a brain tumor and be at least six months post-treatment. They will be randomly placed into one of three groups: one group will receive cognitive rehabilitation with fatigue management, another will receive cognitive rehabilitation alone, and the last group will receive usual care. Throughout the study, participants and their families will answer questionnaires and take part in interviews to share their experiences. This research aims to understand whether these treatments are practical and beneficial, paving the way for a larger study in the UK.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age range: 7 years to 17 years, 11 months.
• • 2. Received diagnosis and/or treatment/surveillance at GOSH for a childhood tumour that involved the CNS (brain) and/or oncology treatment to brain.
• • 3. 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.
• • 4. At least 6 months post-diagnosis/acute treatment (surgery and/or radiotherapy), and 3 months post-return to school, with stable disease.
• • 5. 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).
• • 6. Report impairment (z-score \> -0.67) in fatigue on one or more subscales of the PedsQL Multidimensional Fatigue Scale.
• • 7. Capacity/competence of patient or parent/carer to provide informed
• Exclusion Criteria:
• • 1. Completed or having another targeted formal psychological intervention for cognitive rehabilitation or fatigue in the past 6 months.
• • 2. Sensorimotor (e.g., visual-motor) impairment only on neuropsychological assessment without additional cognitive difficulty.
• • 3. Current substance misuse from self-report.
• • 4. 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).
• • 5. 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.
• • 6. Patient and parent/carer is unable to communicate verbally and in written form in English.