- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05483166
Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study
Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The "I'm Aware: Parents and Children Together" (ImPACT) Program - A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cecilie R Buskbjerg, PhD
- Phone Number: +4529842526
- Email: cdrc@psy.au.dk
Study Contact Backup
- Name: Lisa M Wu, PhD
- Phone Number: +45 87 15 37 48
- Email: lisa.wu@oncology.au.dk
Study Locations
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-
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Aarhus, Denmark, 8000
- Recruiting
- Aarhus University
-
Contact:
- Cecilie R Buskbjerg, Ph.D.
- Phone Number: +45 29842526
- Email: cdrc@psy.au.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ImPACT program
The ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions.
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During the ImPACT program, the childhood cancer survivor and at least one parent collaborates on:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
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.
|
Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent-reported neurobehavioral functioning
Time Frame: 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.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Parent-reported cognitive functioning
Time Frame: 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.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Child-reported neurobehavioral functioning
Time Frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
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.
|
Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Child-reported neurobehavioral functioning
Time Frame: 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.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Child-reported cognitive functioning
Time Frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
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.
|
Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Child-reported cognitive functioning
Time Frame: 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.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Parent-reported pediatric quality of life
Time Frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
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.
|
Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Parent-reported pediatric quality of life
Time Frame: 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.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Child-reported pediatric quality of life
Time Frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
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.
|
Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Child-reported pediatric quality of life
Time Frame: 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.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Parent-reported pediatric anxiety and depression
Time Frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
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.
|
Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Parent-reported pediatric anxiety and depression
Time Frame: 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.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Child-reported pediatric anxiety and depression
Time Frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
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.
|
Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Child-reported pediatric anxiety and depression
Time Frame: 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.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Parent-reported pediatric fatigue
Time Frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
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.
|
Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Parent-reported pediatric fatigue
Time Frame: 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.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Child-reported pediatric fatigue
Time Frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
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.
|
Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Child-reported pediatric fatigue
Time Frame: 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.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Parent sense of competence
Time Frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
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.
|
Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Parent sense of competence
Time Frame: 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.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Parent-reported participant motivation
Time Frame: 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.
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After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
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Child-reported participant motivation
Time Frame: 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.
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After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3))
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Parent-reported participant satisfaction
Time Frame: 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.
|
After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
|
Child-reported participant satisfaction
Time Frame: 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.
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After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
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Objective cognitive functioning (Child only)
Time Frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Standard neuropsychological test battery.
Different scoring formats.
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Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
|
Objective cognitive functioning (Child only)
Time Frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Standard neuropsychological test battery.
Different scoring formats.
|
Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative Interviews
Time Frame: 9 week after post-intervention (approximately 18 weeks after Baseline assessment (T1): Follow-up, T4)
|
Following the T4 assessment, the child and parent(s) will be invited to participate in a 30-minutes semi-structured, audio recorded interview.
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9 week after post-intervention (approximately 18 weeks after Baseline assessment (T1): Follow-up, T4)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa M Wu, PhD, University of Aarhus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ImPACT Child
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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