KEYS to Succeed: Cognitive and Academic Intervention Program for Children and Adolescents Surviving Cancer

Study Overview
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Brief Summary
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The study will examine whether school liaison services and home-based parental tutoring can help with academic difficulties of paediatric brain tumour survivors who received cranial spinal radiation and have returned to school. Forty-five patients will participate in the project. All patients will receive psychology liaison services to link resources at the hospital with those in the community. Patients will participate in one of two tutoring programs designed to directly or indirectly improve math skills over 12 weeks. Weekly phone calls will be used to support parents using the program. Patients will be tested before, immediately after, and six months following each tutoring program to assess growth in mathematics and working memory abilities.

Detailed Description
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Paediatric brain tumour survivors who receive cranial spinal radiation have learning problems, particularly in mathematics and working memory. Working memory is often described as a mental workspace where relevant information is held in mind and processed. Working memory is important in mathematics for holding in mind relevant information and carrying out steps necessary to solve problems. This study will examine whether school liaison support and home-based parental tutoring can help address the academic difficulties of paediatric brain tumour survivors who have received cranial spinal radiation and who have returned to their community school. Forty five patients will participate in the project. First, all patients will receive psychology liaison services to link resources at the hospital with those in the community in order to provide information regarding the effects of pediatric cancer on learning and facilitate the implementation of appropriate assistive technology and remediation programs. Patients will then participant in one of two tutoring programs over the course of a 12 week period. One group of patients will participate in a program that addresses working memory with the intent of indirectly helping with mathematics skills. This program will be delivered over the internet. Another group of patients will participate in a program using a work book to directly help improve mathematics skills. Weekly phone calls will be used to support parents in doing the program. Patients will be tested before, immediately after, and six months following each tutoring program to assess growth in mathematics and working memory abilities. The two intervention programs will be compared to a waitlist control group that receives only the liaison service (including academic support through weekly phone calls over the 12 weeks). The findings from this study will provide evidence about the type of intervention that is most effective at helping paediatric brain tumour survivors improve their mathematics skills and working memory ability.

Official Title
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KEYS to Succeed: Cognitive and Academic Intervention Program for Children and Adolescents Surviving Cancer

Conditions
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Childhood Brain Tumor

Intervention / Treatment
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* Behavioral: Jump Math
* Behavioral: Cogmed
* Behavioral: Liaison Services


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has been diagnosed with a brain tumour and treated with cranial radiation Is between 1 and 10 years following diagnosis Has English as his or her native language or has had at least two years of schooling in English Is between the ages of 6 and 17 Less than a Grade 8 equivalent math score Exclusion Criteria: Is younger than 6 years or older than 17 years of age Is receiving palliative care

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Math + Liaison Service<br>To help with mathematics, participants will be assigned to a workbook based version of the JUMP Math program which will be completed at home with a parent. This intervention focuses on mental math skills. In addition all participants will receive the liaison service program. | Behavioral: Jump Math<br>* Jump Math is a workbook based program aimed at improving math skills<br>Behavioral: Liaison Services<br>* Liaison Services will include working closely with schools to help explain the strengths and weaknesses of a child based on cognitive testing and to help with the implementation of recommendations<br>|
| Experimental: Working Memory + Liaison Service<br>To help with working memory, participants will be assigned to Cogmed, a game-like computer exercise focusing on improving working memory. In addition all participants will receive the liaison service program. | Behavioral: Cogmed<br>* Cogmed is an online computer program aimed at improving working memory skills<br>Behavioral: Liaison Services<br>* Liaison Services will include working closely with schools to help explain the strengths and weaknesses of a child based on cognitive testing and to help with the implementation of recommendations<br>|
| Other: Liaison Services<br>Participants in this group will only receive the liaison service program for 12 weeks before being assigned to one of the intervention groups. | Behavioral: Liaison Services<br>* Liaison Services will include working closely with schools to help explain the strengths and weaknesses of a child based on cognitive testing and to help with the implementation of recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Woodcock Johnson Academic-Third Edition | A measure of math Fluency, applied math problems, and qualitative concepts | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 
| Wechsler Intelligence Scale for Children - Fourth Edition Integrated | A measure of verbal and visual working memory | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 
| Wide Range Assessment of Memory and Learning - Second Edition | A measure of verbal and visual working memory | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 
| Automated Working Memory Assessment | A measure of verbal and visual working memory | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 
| Connors' Continuous Performance Test-Second Edition | A measure of sustained attention | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 
| Behaviour Rating Inventory of Executive Function-Parent Version | A measure of executive functioning | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 
| Monitoring Basic Skills Progress | A measure of mathematics | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAM | A measure of participants attitude towards math | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 
| Wide Range Assessment of Memory and Learning - Second Edition | A measure of visual learning and memory | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 
| California Verbal Learning Test, Children's Version | A measure of verbal learning and memory | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 
| CANTAB | Measures of processing speed | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 
| Wechsler Abbreviated Scale of Intelligence - Second Edition | A measure of vocabulary and abstract visual reasoning | Pre-intervention, 12 weeks after intervention and 6 months follow-up | 
| Delis-Kaplan Executive Function System | Measures of processing speed and switching attention | Pre-intervention, 12 weeks after intervention and 6 months follow-up |