Social Cognition Assessment and Rehabilitation for Families living with Brain Tumour (SCARF-BT) : a Feasibility Study

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 – 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.