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Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy

This study is currently recruiting participants.
Verified July 2017 by Children's Oncology Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT01503086
First Posted: January 2, 2012
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose
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.

Condition Intervention
Childhood Brain Tumor Cognitive/Functional Effects Neurotoxicity Psychosocial Effects of Cancer and Its Treatment Radiation Toxicity Other: computer-assisted cognitive training Other: questionnaire administration Procedure: cognitive assessment Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Intervention compliance defined as at least 80% of sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training) [ Time Frame: Up to 9 weeks ]
    Z-test for binomial proportion with continuity correction will be used. Confidence intervals of the estimated compliance rate will be constructed for the overall study population and for each arm separately. Described by summary statistics such as mean or median, and compared between the 2 arms by two-sample t-test or Wilcoxon rank sum test.


Secondary Outcome Measures:
  • Parent-rated executive function and WM using the Metacognition subscales from the Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Up to 6 months ]
  • Executive function using the Groton Maze Learning and Set Shifting tasks of the CogState battery [ Time Frame: Up to 6 months ]
  • WM by the Two-back task from CogState and Digit Span from Wechsler Intelligence Scales [ Time Frame: Up to 6 months ]
  • Verbal and visual memory using Dot Location from Children's Memory Scale Spatial Span from Wechsler Scale [ Time Frame: Up to 6 months ]
  • Technical feasibility based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months ]
  • Adherence [ Time Frame: Up to 6 months ]
  • Satisfaction and ease of use [ Time Frame: Up to 6 months ]

Estimated Enrollment: 71
Study Start Date: November 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (interactive training program)
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 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.
Other: computer-assisted cognitive training
Receive computer-assisted cognitive training
Other: questionnaire administration
Ancillary studies
Procedure: cognitive assessment
Ancillary studies
Procedure: psychosocial assessment and care
Ancillary studies
Other Names:
  • psychosocial assessment
  • psychosocial assessment/care
  • psychosocial care
  • psychosocial care/assessment
  • psychosocial studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm II (non-adaptive training program)
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 WIS-IV, the CMS, and the 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.
Other: computer-assisted cognitive training
Receive computer-assisted cognitive training
Other: questionnaire administration
Ancillary studies
Procedure: cognitive assessment
Ancillary studies
Procedure: psychosocial assessment and care
Ancillary studies
Other Names:
  • psychosocial assessment
  • psychosocial assessment/care
  • psychosocial care
  • psychosocial care/assessment
  • psychosocial studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503086


Locations
United States, California
Children's Oncology Group Recruiting
Arcadia, California, United States, 91006-3776
Contact: Kristina K. Hardy, PhD    202-476-4304    khardy@cnmc.org   
Principal Investigator: Kristina K. Hardy, PhD         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Jeffrey S. Dome    202-884-2549      
Principal Investigator: Jeffrey S. Dome         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Robert Hayashi, MD    314-454-2041      
Principal Investigator: Robert Hayashi, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Frank M. Balis    215-590-2810      
Principal Investigator: Frank M. Balis         
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105-2794
Contact: Wayne Lee Furman, MD    901-495-3300      
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Patrick J. Leavey    214-648-7097      
Principal Investigator: Patrick J. Leavey         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Anne-Marie R. Langevin, MD    210-567-0653    che@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin, MD         
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Gita V. Massey    804-628-1939      
Principal Investigator: Gita V. Massey         
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sarah W. Alexander    416-813-7654ext2027    jason.mcguire@sickkids.ca   
Principal Investigator: Sarah W. Alexander         
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kristina Hardy, PhD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01503086     History of Changes
Other Study ID Numbers: ACCL10P1
NCI-2012-00112 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000721387 ( Other Identifier: ClinicalTrials.gov )
COG-ACCL10P1 ( Other Identifier: Children's Oncology Group )
COG-ACCL10P1 ( Other Identifier: DCP )
ACCL10P1 ( Other Identifier: CTEP )
U10CA095861 ( U.S. NIH Grant/Contract )
First Submitted: December 30, 2011
First Posted: January 2, 2012
Last Update Posted: July 12, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Brain Neoplasms
Neurotoxicity Syndromes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders