Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study

Cognitive Dysfunction Clinical Trial

Official title:

Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The "I'm Aware: Parents and Children Together" (ImPACT) Program - A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05483166
• Other study ID #: ImPACT Child
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: Aarhus University Hospital
• Contact: Lisa M Wu, PhD
• Phone: +45 87 15 37 48
• Email: lisa.wu[@]oncology.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Pediatric Cancer

Intervention

Behavioral:
• ImPACT
During the ImPACT program, the childhood cancer survivor and at least one parent collaborates on: Becoming aware of the child's core strengths and difficulties Helping the child to be optimally responsive to the guidance of the parent(s), and Creating compensatory strategies to respond to real-world manifestations of the child's difficulties and helping the child implement these strategies at home.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative Interviews	Following the T4 assessment, the child and parent(s) will be invited to participate in a 30-minutes semi-structured, audio recorded interview.	9 week after post-intervention (approximately 18 weeks after Baseline assessment (T1): Follow-up, T4)
Primary	Parent-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.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Primary	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.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Secondary	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.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Secondary	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.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Secondary	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.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Secondary	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.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Secondary	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.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Secondary	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.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Secondary	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.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Secondary	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.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Secondary	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.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Secondary	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.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary	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.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Secondary	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.	After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Secondary	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.	After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3))
Secondary	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.	After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Secondary	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.	After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Secondary	Objective cognitive functioning (Child only)	Standard neuropsychological test battery. Different scoring formats.	Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary	Objective cognitive functioning (Child only)	Standard neuropsychological test battery. Different scoring formats.	Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)