Title: Social Cognition Assessment and Rehabilitation for Families living with Brain Tumour (SCARF-BT) : a Feasibility Study
Funder: Department of Health and Social Care

Abstract: Research question: This study will ask is it feasible to use a computer-delivered rehabilitation strategy for defects of emotional recognition (developed for traumatic brain injury patients) in patients with malignant brain tumours? Background: As malignant brain tumours are currently not cured. Our aim is to maintain patients quality of life. Cognitive deficits are a major issue for patients &ndash; many find difficulties with relationships and become isolated. As most of our communication is non-verbal, emotional recognition is a key element of this social cognition and interaction with others. Initial data shows over half of patients have deficits and slow processing speeds at diagnosis. Rehabilitation can help improve cognitive deficits. The FACES intervention was developed to manage the 3 mechanisms of emotional recognition. A randomised trial of this intervention has shown improvement in emotional recognition. Brain tumour patients are different, however. Fatigue and the progressive disease may impact efficacy and method of administering the rehabilitation in brain tumour patients. At present there is a paucity of evidence for targeted rehabilitation in brain tumours patients. Aims and objectives: This study aims to explore the feasibility of targeted rehabilitation of social cognition in brain tumour patients. Objectives will explore the feasibility of: Screening suitable patients; Administering intervention; Explore compliance with intervention; Acceptability of intervention and assessment tools; Assess effect size to guide and power potential efficacy studies. Methods: Patients will be screened pre-operatively and patients with emotional recognition deficits who are to undergo surgery for high-grade gliomas who have no significant medical or psychiatric problems that would interfere with the rehabilitation will be recruited post-operatively. The rehabilitation intervention will be performed before radiotherapy in 3 hourly sessions over a three week period. Validated assessment tools will be used at baseline and after the rehabilitation. The study is in two Stages with a parallel qualitative study exploring acceptability and guide the best way of running the study. Stage 1: this will recruit approximately 10 patients to test the screening method, recruitment rate and rehabilitation intervention. We will learn the best way of administering the intervention and assessing it. Stage 2: this will randomise patients between an intervention group (FACES intervention) and a control group (general cognitive tests) as we know there is a placebo effect. Parallel qualitative study:will involve group and individual sessions before Stage 1 (to assess potential barriers as well as lived experience) after Stage 1 (to develop the method for Stage 2) and then after Stage 2 (assess outcomes). Timelines for delivery: This is a 3-year study. After a lead-in period where we explore the best way of administering the intervention, we aim to complete Stage 1 before the end of Year 1, learn from patients before commencing Stage 2 by year 2. We are estimating 2 patients per month recruitment. Anticipated Impact and Dissemination: This study will determine best method for using this rehabilitation intervention, how to assess the intervention as well as effect size for brain tumour patients. We will use our PPI panel to help with patient/public dissemination.

Lay abstract: Why is this research important? Brain tumours are unlike other cancers. They can change the things that make us who we are, such as our memory, thinking, personality and how we interact with others. People living with a brain tumour are more likely to have these problems than problems with movement, speech or vision. These are the things our treatment services concentrate on. Maintaining quality of life must be our aim, as these people are rarely cured. Detecting emotions in friends and family is a key part of relationships. We recognise emotions using hints (cues) such as facial expression and body language. When patients can t engage with others it leaves them, and their carers, isolated and alone. Our studies suggest that over half of our patients with malignant brain tumours have problems with this emotional recognition. How will this research help? Similar problems can occur following head injuries and strokes. Rehabilitation helps improve emotional recognition. We think rehabilitation can help the brain to re-organise and recover the skills it has lost. We want to see if rehabilitation methods that work in patients following head injuries or stroke also work in patients with brain tumours. The method we will use is called FACES and helps patients re-learn how to recognise emotions in others. What will we do? Patients visiting our brain tumour clinic will be asked if they wish to take part in this study. Those who agree will have a screening test. If the test shows problems with detecting emotions in others, we will invite them to join the study. Only those who give their consent will take part. The study will be in two stages: Stage 1: A small group of patients (~10) will try the FACES rehabilitation. This involves 3 training sessions of 60 minutes each week for 3 weeks, done at home using a computer. Patients will be supported by a trained assistant psychologist. We will compare results from tests at the beginning and end of the study to see if the rehabilitation works, and ask patients and carers how they found the study. This will let us know how to best run a larger study in Stage 2. Stage 2: In this larger study, at least 19 patients testing the FACES rehabilitation programme will be compared with a similar number of patients testing a general computer-based programme. The choice of rehabilitation programme will be made at random by a computer. Again, patients will be tested before and after their rehabilitation. Our goal is to develop a clinical service that can treat common emotional and cognitive problems in brain tumour patients. This will enable them to feel less isolated and better able to be involved in society.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: CANCER AND NEOPLASMS