The aim of the present pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for childhood cancer survivors and their families.
Cognitive impairment is the most common late effect in childhood cancer survivors, and despite the negative effects of these symptoms on quality of life, scholastic achievement and long-term socioeconomic outcomes, there continues to be no "gold standard" treatment for childhood cancer survivors with cognitive impairment. Indeed, there is a dearth of research on interventions to treat cognitive impairment in childhood 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 parents 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: Parents and Children Together (ImPACT)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of this program in childhood cancer survivors with cognitive impairment in preparation for a large-scale randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
During the ImPACT program, the childhood cancer survivor and at least one parent collaborates on: 1. Becoming aware of the child's core strengths and difficulties 2. Helping the child to be optimally responsive to the guidance of the parent(s), and 3. Creating compensatory strategies to respond to real-world manifestations of the child's difficulties and helping the child implement these strategies at home.
Aarhus University
Aarhus, Denmark
RECRUITINGParent-reported neurobehavioral functioning
The parent-report screening version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 12 items: answer format range: 1-3; total score range: 12-36. Higher score indicates more impairment.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported cognitive functioning
The parent-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported neurobehavioral functioning
The parent-report version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 63 items: answer format range: 1-3; total score range: 63-189. Higher score indicates more impairment.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported cognitive functioning
The parent-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported neurobehavioral functioning
The child-report version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 55 items: answer format range: 1-3; total score range: 55-165. Higher score indicates more impairment.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
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Child-reported neurobehavioral functioning
The child-report version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 55 items: answer format range: 1-3; total score range: 55-165. Higher score indicates more impairment.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported cognitive functioning
The child-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported cognitive functioning
The child-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported pediatric quality of life
The parent-report version of the Pediatric Quality of Life (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate more impairment.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported pediatric quality of life
The parent-report version of the Pediatric Quality of Life Inventory (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate lower quality of life.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported pediatric quality of life
The child-report version of the Pediatric Quality of Life (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate more impairment.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported pediatric quality of life
The child-report version of the Pediatric Quality of Life (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate more impairment.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported pediatric anxiety and depression
The parent-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported pediatric anxiety and depression
The parent-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported pediatric anxiety and depression
The child-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported pediatric anxiety and depression
The child-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported pediatric fatigue
The parent-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported pediatric fatigue
The parent-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported pediatric fatigue
The child-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported pediatric fatigue
The child-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent sense of competence
The Parenting Sense of Competence Scale (PSC scale).17 items: answer format range 1-6; total score range: 16-102. Higher score indicates more competence.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent sense of competence
The Parenting Sense of Competence Scale (PSC scale). 17 items: answer format range 1-6; total score range: 16-102. Higher score indicates more competence.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-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: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Child-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: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3))
Parent-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: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Child-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: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Objective cognitive functioning (Child only)
Standard neuropsychological test battery. Different scoring formats.
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Objective cognitive functioning (Child only)
Standard neuropsychological test battery. Different scoring formats.
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)