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

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.

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

Conditions
-----------------
Pediatric Cancer, Cognitive Dysfunction

Intervention / Treatment
-----------------
* Behavioral: ImPACT


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ImPACT program<br>The ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions. | Behavioral: ImPACT<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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)) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric Cancer, Cognitive Dysfunction, Neuropsychological Rehabilitation, Neurobehavioral Impairment