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

Childhood Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573441
• Other study ID #: 1000043747
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 2018

Study information

• Verified date: June 2024
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Brain Tumor

Intervention

Behavioral:
• Jump Math
Jump Math is a workbook based program aimed at improving math skills
• Cogmed
Cogmed is an online computer program aimed at improving working memory skills
• Liaison Services
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

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Pediatric Oncology Group of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Automated Working Memory Assessment	A measure of verbal and visual working memory	Pre-intervention, 12 weeks after intervention and 6 months follow-up
Primary	Connors' Continuous Performance Test-Second Edition	A measure of sustained attention	Pre-intervention, 12 weeks after intervention and 6 months follow-up
Primary	Behaviour Rating Inventory of Executive Function-Parent Version	A measure of executive functioning	Pre-intervention, 12 weeks after intervention and 6 months follow-up
Primary	Monitoring Basic Skills Progress	A measure of mathematics	Pre-intervention, 12 weeks after intervention and 6 months follow-up
Secondary	SAM	A measure of participants attitude towards math	Pre-intervention, 12 weeks after intervention and 6 months follow-up
Secondary	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
Secondary	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
Secondary	CANTAB	Measures of processing speed	Pre-intervention, 12 weeks after intervention and 6 months follow-up
Secondary	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
Secondary	Delis-Kaplan Executive Function System	Measures of processing speed and switching attention	Pre-intervention, 12 weeks after intervention and 6 months follow-up