Defects of emotional recognition in brain tumour (glioblastoma) patients Mental and Behavioural Disorders
Conditions
Interventions
This study comprises two stages: Stage 1 where all patients will receive the FACES intervention and Stage 2 where patients will be randomised 1:1 to receive either the FACES intervention or a placebo
before stage 1, after stage 1 and after stage 2.
STAGE 1:
This is a non-randomised study. All patients will undergo the FACES Intervention. Patients will complete assessments to measure deficits in
half receiving the FACES intervention (active intervention) and the other half receiving the General Cognition Intervention (control intervention). As with Stage 1, patients will complete assessments
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1. Patients pre-screened as part of the CogENT and SIND studies, scoring 11 or less on the emotional recognition test within the OCS-Bridge screening tool done pre-operatively (consistent with having a deficit pre-operatively) 2. Signed Informed Consent to SCARF-BT study 3. Aged 18 years and older 4. Imaging evidence of a high-grade glioma as assessed by a neuro-oncology MDT 5. MDT and treating clinician recommend either biopsy or debulking of the tumour; 6. Patients scoring 11 or less on the emotional recognition test within the OCS-Bridge screening tool done post-operatively (consistent with having a deficit post-operatively) 7. Patients with WHO Performance status 0-2 8. Patients suitable for oncological intervention (involving radiotherapy/ chemotherapy/ combining radiotherapy and chemotherapy) 9. For Qualitative Study only: speaks fluent English as the use of interpreters can alter patients exact words 10. For Qualitative Study only: willing to participate in the interviews and/or focus groups Carers: 1. Written informed consent 2. Family member/someone they care for with Brain Tumour who is participating in this study 3. Able and willing to complete the caregiver Quality of Life questionnaire 4. For Qualitative Study only: speaks fluent English as the use of interpreters can alter patients exact words 5. For Qualitative Study only: willing to participate in interviews and/or focus groups
Exclusion criteria
Exclusion criteria: 1. Patients unable to give written consent or who lack capacity to consent 2. Patients for palliative/best supportive care only, following surgery 3. Pre-morbid developmental or acquired/traumatic neurologic disorder (e.g. autism, stroke, severe head injury or dementia/cognitive impairment) 4. Pre-morbid major psychiatric disorder (e.g., schizophrenia) Impaired vision and/or hearing that would interfere with task participation (determined by interacting with participant on screening and medical history) 5. Patients have impairment of facial recognition (i.e. prosopagnosia) using the OCS-Bridge screening tool score of >5 on immediate assessment 6. Impaired facial recognition (i.e. prosopagnosia) using a separate test from the OCS-Bridge screening tool, where a score of =5 on immediate assessment of neutral face recognition would suggest a deficit requiring exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1: the cohort study 1. Completion of the Faces intervention (defined as completing all 9 sessions) recorded at the end of the 3-week intervention (post-intervention) 2. Changes to the administration, conduct and content of the rehabilitation intervention measured by recording the data on a patient-by-patient basis at the end of the 3-week intervention (post-intervention) 3. The acceptability of the intervention measured during interviews/focus groups through a parallel qualitative study before the start of stage 1, after completion of stage 1 and after completion of stage 2 4. Percentage of patients completing the following validated outcome assessments at baseline and post-intervention: Emotional recognition measured using: 4.1. Diagnostic Assessment of Non-verbal Accuracy-2, Adult Faces (DANVA2-AF) 4.2. Emotion Recognition and Social Inference: The Awareness of Social Inference Test (TASIT), (part 1, EET subtest) 4.3. The Toronto Alexithymia Scale-20 (TAS-20) 5. The percentage of patients and carers able to complete the following quality of life questionnaires at baseline and post-intervention: 5.1. Patients: quality of life measured using EORTC QLQ30+BN20 5.2. Carers: effect on family measured using CQOLC Stage 2: placebo-controlled feasibility randomised controlled trial The outcome measures for this stage will be: 1. Screening rate: the number of patients who undergo screening (the numerator) and the number of potentially eligible patients that attend clinic (the denominator), recorded at screening 2. The screened patients meeting the eligibility criteria that provide informed consent for the study, measured by recording the percentage of screening at baseline 3. Patients who have completed all sessions for the FACES intervention (active intervention) and General Cognition Intervention (control intervention), measured post-intervention 4. Percentage of patients completing the following validated outcome assessments at baseline and post-Intervention: | — |
Secondary
| Measure | Time frame |
|---|---|
| To provide an early indicator that the intervention may make some difference and would be worth exploring in a larger multicentre study, the researchers will calculate the difference in scores pre and post intervention for the selected validated outcome assessments (listed in the primary outcome measures), for both the active (FACES) intervention group and the control group, measured at baseline and post intervention. | — |
Countries
England, United Kingdom
Outcome results
None listed