The FLaME Cognitive Rehabilitation Study for Childhood Brain Tumour

NCT06770335 | Not Yet Recruiting

• 1 other identifier: 22BO24
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 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

Childhood Brain Tumor; Childhood Brain Tumors; Pediatric Brain Neoplasms; Pediatric Brain Tumor

Keywords

Paediatric brain tumour; cognitive rehabilitation; cognition; fatigue; feasibility; acceptability; neuropsychology; neurocognitive; childhood brain tumour

Outcome Measures

Primary Outcomes (2)

• 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

  From enrolment to week 14

• 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

  From enrolment to week 14

Secondary Outcomes (6)

• Multidimensional Fatigue Scale

  From enrolment to week 14

• Individual daily fatigue analogue scale

  From enrolment to week 14

• % School attendance

  From enrolment to week 14

• Behaviour Rating Inventory of Executive Function, Second Edition (BRIEF2)

  From enrolment to week 14

• Paediatric Quality of Life Inventory (PedsQL) Core + Brain Tumour Module Cognitive Problems scale

  From enrolment to week 14

Study Arms (3)

Cognitive rehabilitation with fatigue management

EXPERIMENTAL

A 12-week block of intervention (strategy-based cognitive rehabilitation with fatigue management)

Behavioral: THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Full intervention

Cognitive rehabilitation only

EXPERIMENTAL

A 6-week block of intervention (strategy-based cognitive rehabilitation alone)

Behavioral: THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Cognitive rehabilitation only

Standard care

NO INTERVENTION

Standard care only

Interventions

THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Full intervention BEHAVIORAL

A 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.

Cognitive rehabilitation with fatigue management

THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Cognitive rehabilitation only BEHAVIORAL

A 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.

Cognitive rehabilitation only

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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).
• Report impairment (z-score \> -0.67) in fatigue on one or more subscales of the PedsQL Multidimensional Fatigue Scale.
• Capacity/competence of patient or parent/carer to provide informed

You may not qualify if:

• 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).
• 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.
• Patient and parent/carer is unable to communicate verbally and in written form in English.

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• 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

Study Sites (1)

Great Ormond Street Hospital for Children

London, London, WC1N 3JH, United Kingdom

Location

Related Publications (7)

• Irestorm 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 BACKGROUND

• Patel 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 BACKGROUND

• Butler 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 BACKGROUND

• Simons 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 BACKGROUND

• Hocking 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 BACKGROUND

• Treadgold 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 BACKGROUND

• Lassaletta 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.

  PMID: 26351237 BACKGROUND

Related Links

• NIHR funding awards information

MeSH Terms

Conditions

Fatigue

Interventions

Educational Status; CASP8 and FADD-Like Apoptosis Regulating Protein

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Death Domain Receptor Signaling Adaptor Proteins; Adaptor Proteins, Signal Transducing; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Tumor Necrosis Factor Receptor-Associated Peptides and Proteins; Apoptosis Regulatory Proteins; Carrier Proteins; Proteins

Study Officials

• Charlotte P Malcolm, DClinPsy

  Great Ormond Street Hospital for Children NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Faraneh Vargha-Khadem, PhD

  Great Ormond Street Hospital for Children NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte P Malcolm, DClinPsy

CONTACT

+442074059200; charlotte.malcolm@gosh.nhs.uk

Tara Murphy, DClinPsy

CONTACT

+442074059200; tara.murphy@gosh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The feasibility study employs a randomised, parallel arm design with a standard care control group

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 13, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)