Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program (ImPACT)

Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The "I'm Aware: Patients and Carers Together" (ImPACT) Program"

The aim of the present randomized-controlled study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for brain cancer survivors.

Cognitive impairment is the most common late effect in brain cancer survivors, with profound negative effects on quality of life, work ability, and socioeconomic outcomes. Still, there is no gold standard approach to treating cognitive impairment in brain cancer survivors. Furthermore, there is a dearth of research on interventions to treat cognitive impairment in brain cancer survivors, and the relatively few studied interventions have proven limited effects. Arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of carers that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions. The "I'M aware: Patients and Carers Together (ImPACT)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present feasibility randomized-controlled study aims to evaluate the feasibility, acceptability, and preliminary efficacy of this program in brain cancer survivors with cognitive impairment in preparation for a subsequent large-scale randomized controlled trial.

Brain Cancer, Brain Tumor, Cognitive Impairment, Neurobehavioral Impairment, Neuropsychological Rehabilitation

During the ImPACT program, the brain cancer survivor and a carer collaborate on: Becoming aware of the patient's core strengths and difficulties Helping the patient to be optimally responsive to the guidance of the carer, and Creating compensatory strategies to respond to real-world manifestations of the patient's difficulties and helping the patient implement these strategies at home.

The Patients Assessment of Own Functioning Inventory (PAOFI). 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment.

The Patients Assessment of Own Functioning Inventory (PAOFI) modified to informant version. 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment.

The self-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment.

The carer-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment.

The Patients Assessment of Own Functioning Inventory (PAOFI). 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment.

The Patients Assessment of Own Functioning Inventory (PAOFI) modified to informant version. 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment.

The self-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment.

The carer-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment.

Global composite z-score based on the HVLT-R; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Verbal Fluency; Conner's Continuous Performance Test III.

Global composite z-score based on the HVLT-R; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Verbal Fluency; Conner's Continuous Performance Test III.

WAIS-IV Information subtest. 26 items; answer format range 0-1; total score range: 0-26. Higher score indicates higher premorbid intellectual functioning.

The Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue). 13 items: answer format range 0-4; total score range: 0-52. Lower score indicates more fatigue.

The Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue) modified to informant version. 13 items: answer format range 0-4; total score range: 0-52. Lower score indicates more fatigue.

The Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue). 13 items: answer format range 0-4; total score range: 0-52. Lower score indicates more fatigue.

The Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue) modified to informant version. 13 items: answer format range 0-4; total score range: 0-52. Lower score indicates more fatigue.

The Mental Fatigue Scale (MFS). 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.

The Mental Fatigue Scale (MFS) modified to informant version. 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.

The Mental Fatigue Scale (MFS). 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.

The Mental Fatigue Scale (MFS) modified to informant version. 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.

The Center for Epidemiologic Studies Depression Scale (CESD). 20 items: answer format range 0-3; total score range: 0-60. Higher score indicates more depression.

The Center for Epidemiologic Studies Depression Scale (CESD). 20 items: answer format range 0-3; total score range: 0-60. Higher score indicates more depression.

The Functional Assessment of Cancer Therapy-Brain (FACT-Br). 50 items; answer format range 0-4; total score range: 0-200. Higher score indicates better health-related quality of life.

The Functional Assessment of Cancer Therapy-Brain (FACT-Br) modified to informant version. 50 items; answer format range 0-4; total score range: 0-200. Higher score indicates better health-related quality of life.

The Functional Assessment of Cancer Therapy-Brain (FACT-Br). 50 items; answer format range 0-4; total score range: 0-200. Higher score indicates better health-related quality of life.

The Functional Assessment of Cancer Therapy-Brain (FACT-Br) modified to informant version. 50 items; answer format range 0-4; total score range: 0-200. Higher score indicates better health-related quality of life.

The self-report version of the Community Integration Questionnaire Revised (CIQ-R). 18 items: answer format range 0-2; total score range: 0-35. Higher score indicates more community integration.

The carer-report version of the Community Integration Questionnaire Revised (CIQ-R). 18 items: answer format range 0-2; total score range: 0-35. Higher score indicates more community integration.

The self-report version of the Community Integration Questionnaire Revised (CIQ-R). 18 items: answer format range 0-2; total score range: 0-35. Higher score indicates more community integration.

The self-report version of the Community Integration Questionnaire Revised (CIQ-R). 18 items: answer format range 0-2; total score range: 0-35. Higher score indicates more community integration.

The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia.

The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia.

The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.

The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.

The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.

The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.

The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.

The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.

The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.

The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.

Following the T4 assessment, participants included in the intervention arm will be invited to participate in a 30-minutes semi-structured, audio recorded interview.

8 weeks after post-intervention (approximately 16 weeks after Baseline assessment (T1): Follow-up, T4)

Inclusion Criteria: Diagnosis of brain cancer Completed primary treatment at least 6 months ago Medically stable Speaks and understand Danish Living with a carer aged 18 or over, who also speaks and understands Danish and consents to participate in the study alongside the patient Exclusion Criteria: • Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment