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Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy
Conditions
Childhood Brain Tumor - Cognitive/Functional Effects - Neurotoxicity - Psychosocial Effects of Cancer and Its Treatment - Radiation Toxicity
Conditions: official terms
Brain Neoplasms - Neurotoxicity Syndromes
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: computer-assisted cognitive training
Type: Other
Name: questionnaire administration
Type: Other
Name: cognitive assessment
Type: Procedure
Name: psychosocial assessment and care
Type: Procedure
Name: quality-of-life assessment
Type: Procedure
Overall Status
Recruiting
Summary
This randomized clinical trial studies how well an adaptive computerized cognitive training program works compared to a non-adaptive computerized cognitive training program in treating younger patients with brain tumor who underwent radiation therapy. Providing a computer training program may improve the well-being and quality of life of patients with cognitive (physical and mental) function difficulties caused by radiation therapy to the brain.
Detailed Description
OBJECTIVES:
I. To assess the feasibility of a home-based, computerized, cognitive training program for patients with pediatric brain tumors who are undergoing cranial radiation therapy (CRT), treated in multiple Children Oncology Group (COG) institutions.
II. To estimate the effect size of this program on measures of attention and working memory in patients with brain tumors treated with CRT in order to design a definitive large-scale clinical trial. (Exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to risk factors, including age (< 8 years vs ≥ 8 years) and treatment intensity (whole brain vs focal radiation). Patients are randomized to 1 of 2 intervention arms.
ARM I (intervention): Patients undergo a home-based, computerized, interactive training program comprising 3-5 sessions of 15-45 minutes every week for 5-9 weeks. The program contains twelve visually engaging and interesting exercises that target skills involving visual-spatial and verbal working memory (WM). The program is adaptive in a way that each difficulty task is automatically adjusted on a trial-by-trail basis to match a patient's current WM. Each patient has an interventional coach who has online access to patient's training sessions and outcomes (pass or fail). Coaches are able to modify the training sequence or make suggestions to patients and/or parents about how progress can be maximized. Coaches also have telephone meetings with patients and/or families once a week to ensure compliance, track progress, provide feedback, and answer questions that arise during training.
ARM II (control): Patients undergo a home-based, computerized, interactive, non-adaptive training program comprising 3-5 sessions of 15-45 minutes a week for 5-9 weeks. Each patient also has an interventional coach as in arm I. Patients in both arms complete a brief neuropsychological/behavioral assessment comprising the Wechsler Intelligence Scale for Children (WIS-IV), the Children's Memory Scale (CMS), and the California Verbal Learning Test-Children's Version (CVLT-C) at baseline, after completion of study, and at 6 months after completion of study. Additionally, parents complete a parent-report questionnaire to gather information about patient's behaviors, thoughts, emotions, adaptive skills, and social and functional impairment. Parents and children also complete surveys about the program regarding technical feasibility, adherence, ease-of-use, and satisfaction.
I. To assess the feasibility of a home-based, computerized, cognitive training program for patients with pediatric brain tumors who are undergoing cranial radiation therapy (CRT), treated in multiple Children Oncology Group (COG) institutions.
II. To estimate the effect size of this program on measures of attention and working memory in patients with brain tumors treated with CRT in order to design a definitive large-scale clinical trial. (Exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to risk factors, including age (< 8 years vs ≥ 8 years) and treatment intensity (whole brain vs focal radiation). Patients are randomized to 1 of 2 intervention arms.
ARM I (intervention): Patients undergo a home-based, computerized, interactive training program comprising 3-5 sessions of 15-45 minutes every week for 5-9 weeks. The program contains twelve visually engaging and interesting exercises that target skills involving visual-spatial and verbal working memory (WM). The program is adaptive in a way that each difficulty task is automatically adjusted on a trial-by-trail basis to match a patient's current WM. Each patient has an interventional coach who has online access to patient's training sessions and outcomes (pass or fail). Coaches are able to modify the training sequence or make suggestions to patients and/or parents about how progress can be maximized. Coaches also have telephone meetings with patients and/or families once a week to ensure compliance, track progress, provide feedback, and answer questions that arise during training.
ARM II (control): Patients undergo a home-based, computerized, interactive, non-adaptive training program comprising 3-5 sessions of 15-45 minutes a week for 5-9 weeks. Each patient also has an interventional coach as in arm I. Patients in both arms complete a brief neuropsychological/behavioral assessment comprising the Wechsler Intelligence Scale for Children (WIS-IV), the Children's Memory Scale (CMS), and the California Verbal Learning Test-Children's Version (CVLT-C) at baseline, after completion of study, and at 6 months after completion of study. Additionally, parents complete a parent-report questionnaire to gather information about patient's behaviors, thoughts, emotions, adaptive skills, and social and functional impairment. Parents and children also complete surveys about the program regarding technical feasibility, adherence, ease-of-use, and satisfaction.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 16 Years
Minimum Age: 6 Years
Gender: Both
Criteria: Inclusion Criteria:
- Patient must be newly diagnosed (i.e., not relapsed) with a brain tumor; patients with pontine glioma are not eligible
- Patients with a history of traumatic brain injury prior to tumor diagnosis are not eligible
- Patients with a tumor relapse or disease progression are not eligible to participate in this trial
- Patient is currently being followed at 1 of the participating sites
- The patient must have an identified caregiver who is willing and able to oversee the training practice during the intervention period (i.e., for 5-9 weeks starting approximately 3 months after completion of cranial radiation therapy [CRT])
- The patient and caregiver must have reading, speaking, and listening comprehension of English
- Patients with photosensitive seizures are not eligible to participate in this trial
- Patients with a motor, visual, or auditory handicap that prevents computer use (e.g., unresolved posterior fossa syndrome) are not eligible to participate in this trial
- Patient is within three (3) ± one (1) calendar months following completion of cranial radiation therapy (CRT)
- Must not start or change dosage of psycho stimulant medications during the study period
- Patient must be newly diagnosed (i.e., not relapsed) with a brain tumor; patients with pontine glioma are not eligible
- Patients with a history of traumatic brain injury prior to tumor diagnosis are not eligible
- Patients with a tumor relapse or disease progression are not eligible to participate in this trial
- Patient is currently being followed at 1 of the participating sites
- The patient must have an identified caregiver who is willing and able to oversee the training practice during the intervention period (i.e., for 5-9 weeks starting approximately 3 months after completion of cranial radiation therapy [CRT])
- The patient and caregiver must have reading, speaking, and listening comprehension of English
- Patients with photosensitive seizures are not eligible to participate in this trial
- Patients with a motor, visual, or auditory handicap that prevents computer use (e.g., unresolved posterior fossa syndrome) are not eligible to participate in this trial
- Patient is within three (3) ± one (1) calendar months following completion of cranial radiation therapy (CRT)
- Must not start or change dosage of psycho stimulant medications during the study period
Locations
Children's Oncology Group
Arcadia, California, United States
University of Texas Health Science Center at San Antonio
Status: Recruiting
Contact: Kristina K. Hardy, PhD - 202-476-4304 - khardy@cnmc.org
San Antonio, Texas, United States
Status: Recruiting
Contact: Anne-Marie R. Langevin, MD - 210-567-0653 - che@uthscsa.edu
Start Date
November 2013
Sponsors
Children's Oncology Group
Source
Children's Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page