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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
During the ImPACT program, the brain cancer survivor and a carer collaborate on: 1. Becoming aware of the patient's core strengths and difficulties 2. Helping the patient to be optimally responsive to the guidance of the carer, and 3. Creating compensatory strategies to respond to real-world manifestations of the patient's difficulties and helping the patient implement these strategies at home.
Aarhus University Hospital
Aarhus, Denmark
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
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.
Time frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]
Carer-reported cognitive functioning
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)]