Trial record 2 of 78 for:    "Brain tumor childhood"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01503086
First received: December 30, 2011
Last updated: August 5, 2014
Last verified: August 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Executive function using the Groton Maze Learning and Set Shifting tasks of the CogState battery [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • WM by the Two-back task from CogState and Digit Span from Wechsler Intelligence Scales [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Verbal and visual memory using Dot Location from Children's Memory Scale Spatial Span from Wechsler Scale [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Technical feasibility based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Adherence [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Satisfaction and ease of use [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 71
Study Start Date: November 2013
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Texas
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         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Kristina Hardy, PhD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01503086     History of Changes
Other Study ID Numbers: ACCL10P1, NCI-2012-00112, CDR0000721387, COG-ACCL10P1, COG-ACCL10P1, COG-ACCL10P1, ACCL10P1, U10CA095861
Study First Received: December 30, 2011
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014