Not yet recruitingNAINTERVENTIONAL

The FLaME Cognitive Rehabilitation Study for Childhood Brain Tumour

The FLaME study is for children with brain tumours who often have difficulties with memory, attention, and mental tiredness after treatment. These issues can affect their learning and well-being. While guidelines suggest specific therapies, these are often hard to find. This study aims to see if a program called FLaME, which teaches coping skills for thinking difficulties, is helpful and practical for families. It also explores if adding ways to manage tiredness makes the program even better. Children aged 7-17 from Great Ormond Street Hospital will either receive the FLaME program with fatigue help, the FLaME program without it, or usual care. Researchers will gather feedback to develop a wider UK study.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Enrolment target

Start

10 Mar 2025

Estimated completion

31 Dec 2026

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

What is this study about?

When children are treated for brain tumours, it's wonderful that many more are surviving. However, a common challenge many families face afterwards is that children can struggle with 'thinking skills' – things like remembering new information, paying attention in class, or processing things quickly. On top of this, many children experience something called 'cognitive fatigue,' which isn't just being physically tired, but a deep mental tiredness that makes concentrating or thinking hard.

These thinking difficulties and mental tiredness can really impact a child's schoolwork, their friendships, and how they feel about themselves. Experts in the UK suggest a type of therapy called 'cognitive rehabilitation' to help children learn strategies to manage these challenges. However, these helpful therapies are often not widely available because there hasn’t been enough research into how effective they are for children with brain tumours, and how to deliver them so they are easy for families to participate in. Also, sometimes this mental tiredness can make it hard for children to even benefit from rehabilitation.

This study, called FLaME (Fatigue, Learning, and Memory Enrichment), wants to find out if providing specialized cognitive rehabilitation is helpful and practical for children and their families. It will also investigate if adding specific strategies to manage mental tiredness makes the rehabilitation even more effective. The goal is to gather important information so that eventually, these helpful therapies can be offered to more children across the UK.

Key takeaways

Study aims to help children with brain tumours manage thinking difficulties and mental tiredness.
It tests a new program called FLaME, focusing on memory, attention, and fatigue strategies.
Children will be randomly assigned to receive FLaME plus fatigue help, FLaME only, or usual care.
Family feedback is key to understanding if the program is helpful and practical.
The study findings will help develop wider support for children across the UK.

Who may be eligible?

This study is looking for children aged between 7 and 17 years and 11 months who have been treated for a brain tumour at Great Ormond Street Hospital (GOSH). They should have had surgery or radiotherapy at least 6 months ago, and have returned to school for at least 3 months. Their doctors should feel their condition is stable.

To be considered, children must also have had a recent assessment at GOSH that showed some difficulties with thinking skills, such as memory or attention, or difficulties with mental tiredness based on a questionnaire. They or their parents/carers must also be able to understand and speak English well enough to take part.

Children won't be able to join if they have already had a similar therapy for thinking problems or fatigue in the last six months. Also, if their only difficulty is with movement or sight, or if they have certain severe mental health conditions, or a diagnosed intellectual disability. If a child has ADHD and is being treated for it, they might still be able to take part.

Quick self-check

Is your child aged between 7 and 17 years, 11 months?
Has your child been treated for a brain tumour at Great Ormond Street Hospital (GOSH)?
Has it been at least 6 months since your child's main treatment (surgery/radiotherapy) and 3 months since they returned to school?
Has an assessment showed your child has some difficulties with thinking skills (memory, attention) or mental tiredness?
Are you and your child able to communicate in English (verbally and in writing)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part in this study, the first step involves a random assignment to one of three groups, much like picking names out of a hat. Your child will either receive the FLaME program with extra help for managing tiredness (lasting 12 weeks), or the FLaME program focusing only on thinking skills (lasting 6 weeks), or they will continue with their usual care. The therapy sessions will involve learning practical strategies and skills.

Throughout the study, both your child and you, as their carer, will be asked to fill out questionnaires before the therapy starts, during the therapy, and again after it finishes. At the very end of the study, you'll also have an interview with the researchers. These questionnaires and interviews will help the researchers understand how helpful and practical the program was, and how it affected your child's thinking, tiredness, and overall well-being. There won't be any medication involved, and the total duration will depend on which group your child is in, as well as the follow-up assessments.

Potential risks and benefits

Taking part in this study may offer your child the potential to learn new strategies to cope with thinking difficulties and mental tiredness, which could improve their daily life and learning. However, as with any study, there are no guaranteed benefits, and some families might find the commitment to appointments and questionnaires takes time and effort. There are no known physical risks from participating in this type of therapy. It's crucial to remember that you and your child are entirely free to withdraw from the study at any time, for any reason, without needing to explain why, and this will not affect your child's ongoing care at GOSH.

Locations (1)

Great Ormond Street Hospital for Children
London, United Kingdom

Common questions

What is 'cognitive rehabilitation'?

It's a type of therapy that teaches strategies to help improve or manage difficulties with thinking skills like memory and attention.

What is 'cognitive fatigue'?

This is a severe mental tiredness that makes it hard to concentrate, think, or learn, often experienced by children after brain tumour treatment.

Will my child definitely get the FLaME therapy?

Participants are randomly put into one of three groups, so your child might receive the FLaME therapy or continue with usual care.

How long will the study last for my child?

Depending on the group, the therapy part of the study will last either 6 or 12 weeks, plus the time for assessments and follow-up.

What happens after the study?

The information gathered will help researchers develop a program that could be offered more widely to children with brain tumours across the UK.

How to find out more

Charlotte P Malcolm, DClinPsy

charlotte.malcolm@gosh.nhs.uk +442074059200 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.