The FLaME Cognitive Rehabilitation Study for Childhood Brain Tumour
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
SponsorGreat Ormond Street Hospital for Children NHS Foundation Trust
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Full intervention
BehavioralA novel strategy-based cognitive rehabilitation intervention that can be delivered with or without cognitive fatigue management. Skills are targeted sequentially based on a developmental hierarchical model where cognitive fatigue can be addressed first, followed by adult-supported compensatory strategies, with independent use of strategies for specific impairments delivered only once these earlier levels have been addressed. The 'FLaME' program incorporates strategies that have been trialled and found successful in fatigue (e.g., pacing and activity scheduling) and cognitive rehabilitation (e.g., chunking, elaborative encoding techniques) interventions for children. The intervention address two key issues: 1) to deliver strategy-based cognitive rehabilitation as an alternative to prevailing drill-based approaches, and 2) to integrate fatigue management to improve feasibility and acceptability of cognitive rehabilitation. This arm include the full intervention.
THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Cognitive rehabilitation only
BehavioralA novel strategy-based cognitive rehabilitation intervention that can be delivered with or without cognitive fatigue management. Skills are targeted sequentially based on a developmental hierarchical model where cognitive fatigue can be addressed first, followed by adult-supported compensatory strategies, with independent use of strategies for specific impairments delivered only once these earlier levels have been addressed. The 'FLaME' program incorporates strategies that have been trialled and found successful in fatigue (e.g., pacing and activity scheduling) and cognitive rehabilitation (e.g., chunking, elaborative encoding techniques) interventions for children. The intervention address two key issues: 1) to deliver strategy-based cognitive rehabilitation as an alternative to prevailing drill-based approaches, and 2) to integrate fatigue management to improve feasibility and acceptability of cognitive rehabilitation. This arm includes the cognitive rehabilitation only.
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Cognitive rehabilitation with fatigue managementExperimental treatment 1 intervention
Group B: Cognitive rehabilitation onlyExperimental treatment 1 intervention
Group C: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Goal Based Outcome for management of fatigue
The GBO tool is a way of evaluating progress towards goals in clinical work with children, young people, and their families and carers. The GBO compares how far a child or young person feels they have moved towards reaching a goal that they have set for themselves at the beginning of an intervention, on a scale between 0 and 10. 1-3 therapeutic goals are developed collaboratively with a psychologist
Time frame
From enrolment to week 142
Goal Based Outcome for management of cognitive difficulty
The GBO tool is a way of evaluating progress towards goals in clinical work with children, young people, and their families and carers. The GBO compares how far a child or young person feels they have moved towards reaching a goal that they have set for themselves at the beginning of an intervention, on a scale between 0 and 10. 1-3 therapeutic goals are developed collaboratively with a psychologist
Time frame
From enrolment to week 14Secondary outcomes
1
Multidimensional Fatigue Scale
A self-report symptom-specific instrument to measure fatigue in patients with acute and chronic health conditions. Multiple dimensions of fatigue are measured including general fatigue, sleep/rest fatigue, and cognitive fatigue.
Time frame
From enrolment to week 142
Individual daily fatigue analogue scale
Rating of subjective fatigue from 0-10 (0 = no fatigue, 10 = severe fatigue) for the morning and afternoon
Time frame
From enrolment to week 143
% School attendance
UK Govt. method: each day = 2 sessions and averaged per term and conventional threshold of \>=10% of sessions missed as persistent absence)
Time frame
From enrolment to week 144
Behaviour Rating Inventory of Executive Function, Second Edition (BRIEF2)
The BRIEF2 screens for executive function skills/difficulties in children and adolescents ages 5 to 18 years. Three domains evaluate cognitive, behavioural, and emotional regulation, and a Global Executive Composite score provides and overall evaluation of executive functioning
Time frame
From enrolment to week 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov
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