Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program
- Conditions
- Brain CancerCognitive Impairment
- Interventions
- Behavioral: ImPACT program
- Registration Number
- NCT05858359
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
• Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ImPACT program ImPACT program The ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions.
- Primary Outcome Measures
Name Time Method Self-reported cognitive functioning Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) 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.
Carer-reported cognitive functioning Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) 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.
Carer-reported neurobehavioral functioning Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) 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.
Self-reported neurobehavioral functioning Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) 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.
- Secondary Outcome Measures
Name Time Method Carer-reported mental fatigue Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Carer-reported health-related quality of life Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Self-reported community integration Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Self-reported cognitive functioning Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Premorbid intellectual functioning (Patient only) Baseline (T1) WAIS-IV Information subtest. 26 items; answer format range 0-1; total score range: 0-26. Higher score indicates higher premorbid intellectual functioning.
Self-reported fatigue Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Carer-reported cognitive functioning Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Carer-reported neurobehavioral functioning Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Objective cognitive functioning (Neuropsychological tests; Patient only) Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Depression (patient only) Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Self-reported health-related quality of life Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Self-reported participant satisfaction Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Self-reported neurobehavioral functioning Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Self-reported mental fatigue Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] The Mental Fatigue Scale (MFS). 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue.
Carer-reported community integration Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Self-reported participant motivation Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Carer-reported fatigue Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Insomnia Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia.
Carer-reported participant satisfaction Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Carer-reported participant motivation Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] 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.
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus, Denmark