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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ImPACT program | Experimental | The ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions. |
|
| Waitlist | No Intervention | Waitlist control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ImPACT program | Behavioral | During the ImPACT program, the brain cancer survivor and a carer collaborate on:
|
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Interviews | 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:
Exclusion Criteria:
• Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Wu, PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8270 | Denmark |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Randomized waitlist controlled trial
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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. |
| 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)] |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |