Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study
- Conditions
- Pediatric CancerCognitive Dysfunction
- Interventions
- Behavioral: ImPACT
- Registration Number
- NCT05483166
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Cancer diagnosis of a leukemia, lymphoma, or central nervous system tumor
- Completed primary treatment at least 6 months ago
- Not terminally ill
- Attend school
- Living with one or more parents who speak Danish and are willing to co-participate
- Screened as having parent-reported cognitive and/or neurobehavioral impairment
• Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment that might contribute to cognitive or neurobehavioral impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ImPACT program ImPACT The ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions.
- Primary Outcome Measures
Name Time Method Parent-reported neurobehavioral functioning Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3) 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.
Parent-reported cognitive functioning Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3) 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.
- Secondary Outcome Measures
Name Time Method Parent-reported participant motivation After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3) 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.
Parent-reported neurobehavioral functioning Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) 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.
Parent-reported cognitive functioning Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) 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.
Child-reported neurobehavioral functioning Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) 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.
Child-reported cognitive functioning Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) 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.
Child-reported pediatric quality of life Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) 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.
Parent-reported pediatric anxiety and depression Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) 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.
Child-reported pediatric fatigue Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) 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.
Parent sense of competence Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) 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.
Child-reported participant motivation After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)) 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.
Objective cognitive functioning (Child only) Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) Standard neuropsychological test battery. Different scoring formats.
Parent-reported pediatric quality of life Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) 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.
Child-reported pediatric anxiety and depression Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) 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.
Parent-reported pediatric fatigue Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4) 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.
Parent-reported participant satisfaction After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3) The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Child-reported participant satisfaction After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3) The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Trial Locations
- Locations (1)
Aarhus University
🇩🇰Aarhus, Denmark