Clinical trial NCT02573441: KEYS to Succeed: Cognitive and Academic Intervention Program for Children and Adolescents Surviving Cancer
Official title: KEYS to Succeed: Cognitive and Academic Intervention Program for Children and Adolescents Surviving Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Brain Tumor
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Pediatric Oncology Group of Ontario
First posted: 2015-10-09
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Woodcock Johnson Academic-Third Edition
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
measure: Wechsler Intelligence Scale for Children - Fourth Edition Integrated
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
measure: Wide Range Assessment of Memory and Learning - Second Edition
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
measure: Automated Working Memory Assessment
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
measure: Connors' Continuous Performance Test-Second Edition
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
measure: Behaviour Rating Inventory of Executive Function-Parent Version
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
measure: Monitoring Basic Skills Progress
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
Secondary outcomes:
measure: SAM
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
measure: Wide Range Assessment of Memory and Learning - Second Edition
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
measure: California Verbal Learning Test, Children's Version
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
measure: CANTAB
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
measure: Wechsler Abbreviated Scale of Intelligence - Second Edition
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
measure: Delis-Kaplan Executive Function System
timeFrame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Donald Mabbott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: