Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Brain Cancer, Cognitive Impairment

Intervention / Treatment
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* Behavioral: ImPACT program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized waitlist controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ImPACT program<br>The ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions. | Behavioral: ImPACT program<br>* 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.<br>|
| No Intervention: Waitlist<br>Waitlist control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported cognitive functioning | 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Carer-reported cognitive functioning | 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Self-reported neurobehavioral functioning | 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Carer-reported neurobehavioral functioning | 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported cognitive functioning | 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Carer-reported cognitive functioning | 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Self-reported neurobehavioral functioning | 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Carer-reported neurobehavioral functioning | 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Objective cognitive functioning (Neuropsychological tests; Patient only) | 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Objective cognitive functioning (Neuropsychological tests; Patient only) | 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Premorbid intellectual functioning (Patient only) | WAIS-IV Information subtest. 26 items; answer format range 0-1; total score range: 0-26. Higher score indicates higher premorbid intellectual functioning. | Baseline (T1) | 
| Self-reported 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Carer-reported 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Self-reported 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Carer-reported 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Self-reported 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Carer-reported 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Self-reported 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Carer-reported 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Depression (patient only) | 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Depression (patient only) | 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Self-reported 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Carer-reported 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Self-reported 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Carer-reported 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Self-reported 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Carer-reported 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Self-reported 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Carer-reported 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Insomnia | The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Insomnia | The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Self-reported participant satisfaction | The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Carer-reported participant satisfaction | The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Self-reported participant satisfaction | The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Carer-reported participant satisfaction | The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Self-reported participant 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Carer-reported participant 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. | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | 
| Self-reported participant 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 
| Carer-reported participant 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. | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Cancer, Brain Tumor, Neurobehavioral Impairment, Neuropsychological Rehabilitation, Cognitive Impairment