- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02573441
KEYS to Succeed: Cognitive and Academic Intervention Program for Children and Adolescents Surviving Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Donald Mabbott, Ph.D., The Hospital for Sick Children
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Childhood Brain Tumor
-
Australian & New Zealand Children's Haematology...Medical Research Future Fund; Minderoo Foundation; Children's Cancer Institute...RecruitingChildhood Cancer | Relapsed Cancer | Refractory Cancer | Childhood Leukemia | Childhood Solid Tumor | Childhood Brain TumorAustralia
-
Sydney Children's Hospitals NetworkGerman Cancer Research Center; Australian & New Zealand Children's Haematology... and other collaboratorsActive, not recruitingChildhood Cancer | Relapsed Cancer | Refractory Cancer | Childhood Leukemia | Childhood Solid Tumor | Childhood Brain TumorAustralia
-
National Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Childhood Choroid Plexus Tumor | Childhood Craniopharyngioma | Childhood Ependymoblastoma | Childhood Grade I Meningioma | Childhood Grade II Meningioma | Childhood Grade III Meningioma | Childhood High-grade Cerebellar Astrocytoma | Childhood High-grade Cerebral Astrocytoma and other conditionsUnited States
-
Australian & New Zealand Children's Haematology...The Hospital for Sick Children; Kazia Therapeutics Limited; Day One Biopharmaceuticals... and other collaboratorsNot yet recruitingChildhood Cancer | Refractory Cancer | Recurrent Cancer | Childhood Solid Tumor | Childhood Brain TumorAustralia, Canada
-
National Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Recurrent Neuroblastoma | Recurrent Osteosarcoma | Recurrent Childhood Rhabdomyosarcoma | Previously Treated Childhood Rhabdomyosarcoma | Recurrent Childhood Soft Tissue Sarcoma | Recurrent Childhood Malignant Germ Cell Tumor | Recurrent... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Childhood Atypical Teratoid/Rhabdoid Tumor | Childhood Grade I Meningioma | Childhood Grade II Meningioma | Childhood Grade III Meningioma | Childhood Infratentorial Ependymoma | Childhood Supratentorial Ependymoma | Recurrent Childhood... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Childhood Atypical Teratoid/Rhabdoid Tumor | Childhood Choroid Plexus Tumor | Childhood Craniopharyngioma | Childhood Ependymoblastoma | Childhood Grade I Meningioma | Childhood Grade II Meningioma | Childhood Grade III Meningioma | Childhood High-grade Cerebellar Astrocytoma and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Childhood Atypical Teratoid/Rhabdoid Tumor | Childhood Choroid Plexus Tumor | Childhood Craniopharyngioma | Childhood Ependymoblastoma | Childhood Grade I Meningioma | Childhood Grade II Meningioma | Childhood Grade III Meningioma | Childhood High-grade Cerebellar Astrocytoma and other conditionsUnited States
-
St. Jude Children's Research HospitalAmerican Cancer Society, Inc.RecruitingSolid Tumor, Childhood | Brain Tumor, PediatricUnited States
-
Burzynski Research InstituteTerminatedChildhood Brain TumorUnited States
Clinical Trials on Jump Math
-
The University of Tennessee, KnoxvilleCompletedMath Teachers (Grades 2-8) | Math Students (Grades 2-8)United States
-
University of Southern DenmarkIMK FondenCompletedPhysical Activity | Academic Acheivement
-
Teesside UniversityUniversity of SunderlandRecruitingFrontal Plane Projection Angle | Maximal Countermovement Jump | Repeated 10/5United Kingdom
-
University of Maryland, BaltimoreCompletedChildhood CancerUnited States
-
California State University, San MarcosCompletedOsteoporosis, Osteopenia
-
University of MiamiNot yet recruitingMental Health Wellness 1United States
-
Permedica spaNot yet recruitingTotal Hip ArthroplastyItaly
-
Universidad Francisco de VitoriaSofía Laguarta Val; Alberto Melián OrtizCompletedEffectiveness of Muscular Work and Genetic Variants in Strength Gain of Ischiofemoral and QuadricepsGenetics | Muscle Strength
-
University Hospital, BonnActive, not recruiting
-
Nationwide Children's HospitalCompletedAnkle SprainUnited States