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

January 24, 2024 updated by: Donald Mabbott, The Hospital for Sick Children
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Math + Liaison Service
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.
Jump Math is a workbook based program aimed at improving math skills
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
Experimental: Working Memory + Liaison Service
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.
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
Cogmed is an online computer program aimed at improving working memory skills
Other: Liaison Services
Participants in this group will only receive the liaison service program for 12 weeks before being assigned to one of the intervention groups.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Woodcock Johnson Academic-Third Edition
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
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
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
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
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
A measure of verbal and visual working memory
Pre-intervention, 12 weeks after intervention and 6 months follow-up
Automated Working Memory Assessment
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
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
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
A measure of sustained attention
Pre-intervention, 12 weeks after intervention and 6 months follow-up
Behaviour Rating Inventory of Executive Function-Parent Version
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
A measure of executive functioning
Pre-intervention, 12 weeks after intervention and 6 months follow-up
Monitoring Basic Skills Progress
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
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
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
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
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
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
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
A measure of verbal learning and memory
Pre-intervention, 12 weeks after intervention and 6 months follow-up
CANTAB
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
Measures of processing speed
Pre-intervention, 12 weeks after intervention and 6 months follow-up
Wechsler Abbreviated Scale of Intelligence - Second Edition
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
A measure of vocabulary and abstract visual reasoning
Pre-intervention, 12 weeks after intervention and 6 months follow-up
Delis-Kaplan Executive Function System
Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up
Measures of processing speed and switching attention
Pre-intervention, 12 weeks after intervention and 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Donald Mabbott, Ph.D., The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

October 7, 2015

First Posted (Estimated)

October 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 1000043747

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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