Clinical trial · Interventional
The FLaME Cognitive Rehabilitation Study for Childhood Brain Tumour
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Brain Tumor | Childhood Brain Neoplasm | ALIAS | 0.90 |
| Pediatric Brain Neoplasms | Childhood Brain Neoplasm | ALIAS | 0.90 |
| Pediatric Brain Tumor | Childhood Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Cognitive rehabilitation only | Behavioral | — | UNRESOLVED |
| THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Full intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cognitive rehabilitation with fatigue management
- description
- A 12-week block of intervention (strategy-based cognitive rehabilitation with fatigue management)
- interventionNames
- Behavioral: THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Full intervention
- type
- EXPERIMENTAL
- label
- Cognitive rehabilitation only
- description
- A 6-week block of intervention (strategy-based cognitive rehabilitation alone)
- interventionNames
- Behavioral: THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Cognitive rehabilitation only
- type
- NO_INTERVENTION
- label
- Standard care
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDIrestorm E, Ora I, Linge H, Tonning Olsson I. Cognitive Fatigue and Processing Speed in Children Treated for Brain Tumours. J Int Neuropsychol Soc. 2021 Oct;27(9):865-874. doi: 10.1017/S1355617720001332. Epub 2021 Jan 14. PMID 33441219
- BACKGROUNDPatel SK, Katz ER, Richardson R, Rimmer M, Kilian S. Cognitive and problem solving training in children with cancer: a pilot project. J Pediatr Hematol Oncol. 2009 Sep;31(9):670-7. doi: 10.1097/MPH.0b013e3181b25a1d. PMID 19707159
- BACKGROUNDButler RW, Copeland DR, Fairclough DL, Mulhern RK, Katz ER, Kazak AE, Noll RB, Patel SK, Sahler OJ. A multicenter, randomized clinical trial of a cognitive remediation program for childhood survivors of a pediatric malignancy. J Consult Clin Psychol. 2008 Jun;76(3):367-78. doi: 10.1037/0022-006X.76.3.367. PMID 18540731
- BACKGROUNDSimons DJ, Boot WR, Charness N, Gathercole SE, Chabris CF, Hambrick DZ, Stine-Morrow EA. Do "Brain-Training" Programs Work? Psychol Sci Public Interest. 2016 Oct;17(3):103-186. doi: 10.1177/1529100616661983. PMID 27697851
- BACKGROUNDHocking MC, Paltin I, Quast LF, Barakat LP. Acceptability and Feasibility in a Pilot Randomized Clinical Trial of Computerized Working Memory Training and Parental Problem-Solving Training With Pediatric Brain Tumor Survivors. J Pediatr Psychol. 2019 Jul 1;44(6):669-678. doi: 10.1093/jpepsy/jsz015. PMID 30874803
- BACKGROUNDTreadgold B, Kennedy C, Spoudeas H, Sugden E, Walker D, Bull K. Paediatric neuro-oncology rehabilitation in the UK: carer and provider perspectives. BMJ Paediatr Open. 2019 Dec 15;3(1):e000567. doi: 10.1136/bmjpo-2019-000567. eCollection 2019. PMID 31909222
- BACKGROUNDLassaletta A, Bouffet E, Mabbott D, Kulkarni AV. Functional and neuropsychological late outcomes in posterior fossa tumors in children. Childs Nerv Syst. 2015 Oct;31(10):1877-90. doi: 10.1007/s00381-015-2829-9. Epub 2015 Sep 9.