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

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.
 
ClinicalTrials.gov Identifier: NCT01503086
Recruitment Status : Recruiting
First Posted : January 2, 2012
Last Update Posted : November 24, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date  ICMJE December 30, 2011
First Posted Date  ICMJE January 2, 2012
Last Update Posted Date November 24, 2020
Actual Study Start Date  ICMJE November 18, 2013
Estimated Primary Completion Date March 30, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
Proportion of patients with intervention compliance [ Time Frame: Up to 9 weeks of starting training ]
Intervention compliance defined as at least 80% of sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training).
Original Primary Outcome Measures  ICMJE
 (submitted: December 30, 2011)
Intervention compliance defined as at least 80% of sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2011)
Subjective and objective measures of attention and working memory (WM) including parent-rated executive function, WM, and verbal and visual memory
Current Other Pre-specified Outcome Measures
 (submitted: October 9, 2020)
  • Parent-rated executive function using the Metacognition subscales from the Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Up to 6 months post training completion ]
  • Working memory (WM) using the Metacognition subscales from (BRIEF) [ Time Frame: Up to 6 months post training completion ]
  • Executive function using the Groton Maze Learning task of the CogState battery [ Time Frame: Up to 6 months post training completion ]
  • WM by the one-back task from CogState [ Time Frame: Up to 6 months post training completion ]
  • WM by Digit Span from Wechsler Intelligence Scales [ Time Frame: Up to 6 months post training completion ]
  • Visual working memory using Spatial Span from Wechsler Scale [ Time Frame: Up to 6 months post training completion ]
  • Visual memory using Dot Location from Children's Memory Scale [ Time Frame: Up to 6 months post training completion ]
  • Technical feasibility based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months post training completion ]
  • Adherence based on total number of training sessions completed [ Time Frame: Up to 6 months post training completion ]
  • Satisfaction based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months post training completion ]
  • Ease of use based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months post training completion ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy
Official Title  ICMJE Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study
Brief 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

PRIMARY 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.

EXPLORATORY OBJECTIVES:

I. 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.

OUTLINE: Patients are randomized to 1 of 2 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.

After completion of study treatment, participants are followed up within 3 weeks, then at 6 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Brain Neoplasm
  • Recurrent Brain Neoplasm
Intervention  ICMJE
  • Procedure: Cognitive Assessment
    Ancillary studies
  • Other: Computer-Assisted Cognitive Training
    Receive computer-assisted cognitive training
  • Procedure: Psychosocial Assessment and Care
    Ancillary studies
    Other Name: Psychosocial Care/Assessment
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Cognitive Assessment
    • Other: Computer-Assisted Cognitive Training
    • Procedure: Psychosocial Assessment and Care
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Procedure: Cognitive Assessment
    • Other: Computer-Assisted Cognitive Training
    • Procedure: Psychosocial Assessment and Care
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 30, 2011)
71
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 30, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient must be newly diagnosed or relapsed/progressed with a brain tumor that has not previously been treated with CRT

    • Note: COG therapeutic study participation is not required for ACCL10P1 enrollment
  • Patient enrollment must occur within 4 calendar months following completion of CRT

    • Reminder: after patient enrollment, baseline testing followed by randomization must occur within 2-4 months after completion of CRT
  • The patient must have an identified caregiver who is willing and able to oversee the training practice during the intervention period (ie, for 5-9 weeks starting approximately 3 months after completion of CRT)
  • The patient must have access to a telephone and phone number where they can be reached
  • The patient and caregiver must have reading, speaking and listening comprehension of English
  • All patients and/or their parents or legal guardians must sign a written informed consent (patient assent is also recommended when applicable according to each institution's policy)
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Patients with pontine glioma are not eligible
  • Patients with an estimated survival of less than one year are not eligible
  • Patients with a history of traumatic brain injury prior to tumor diagnosis are not eligible
  • 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
  • Patients with full-scale intelligence quotient (IQ) < 70 per previous testing OR existing diagnosis of/educational classification as a student with an intellectual disability are not eligible
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01503086
Other Study ID Numbers  ICMJE ACCL10P1
NCI-2012-00112 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ACCL10P1
CDR0000721387
ACCL10P1 ( Other Identifier: Children's Oncology Group )
COG-ACCL10P1 ( Other Identifier: DCP )
ACCL10P1 ( Other Identifier: CTEP )
U10CA095861 ( U.S. NIH Grant/Contract )
UG1CA189955 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Oncology Group
Study Sponsor  ICMJE Children's Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Kristina K Hardy Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP