Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The "I'm Aware: Parents and Children Together" (ImPACT) Program - A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Parent-reported neurobehavioral functioning
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment that might contribute to cognitive or neurobehavioral impairment
Outcomes
Primary Outcomes
Parent-reported neurobehavioral functioning
Time Frame: 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
Time Frame: 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 Outcomes
- Child-reported pediatric fatigue(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Parent-reported pediatric anxiety and depression(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Parent-reported neurobehavioral functioning(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Parent-reported cognitive functioning(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Child-reported neurobehavioral functioning(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Child-reported cognitive functioning(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Child-reported pediatric quality of life(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Parent sense of competence(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Child-reported participant motivation(After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)))
- Objective cognitive functioning (Child only)(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Parent-reported pediatric quality of life(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Child-reported pediatric anxiety and depression(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Parent-reported pediatric fatigue(Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4))
- Parent-reported participant motivation(After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3))
- Parent-reported participant satisfaction(After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3))
- Child-reported participant satisfaction(After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3))
Investigators
Lisa Maria Wu
Associate Professor
University of Aarhus