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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 : October 14, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.

Condition or disease Intervention/treatment Phase
Brain Neoplasm Recurrent Brain Neoplasm Procedure: Cognitive Assessment Other: Computer-Assisted Cognitive Training Procedure: Psychosocial Assessment and Care Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study
Actual Study Start Date : November 18, 2013
Estimated Primary Completion Date : March 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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 ]
  2. Working memory (WM) using the Metacognition subscales from (BRIEF) [ Time Frame: Up to 6 months post training completion ]
  3. Executive function using the Groton Maze Learning task of the CogState battery [ Time Frame: Up to 6 months post training completion ]
  4. WM by the one-back task from CogState [ Time Frame: Up to 6 months post training completion ]
  5. WM by Digit Span from Wechsler Intelligence Scales [ Time Frame: Up to 6 months post training completion ]
  6. Visual working memory using Spatial Span from Wechsler Scale [ Time Frame: Up to 6 months post training completion ]
  7. Visual memory using Dot Location from Children's Memory Scale [ Time Frame: Up to 6 months post training completion ]
  8. Technical feasibility based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months post training completion ]
  9. Adherence based on total number of training sessions completed [ Time Frame: Up to 6 months post training completion ]
  10. Satisfaction based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months post training completion ]
  11. Ease of use based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months post training completion ]


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.


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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 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

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
Show Show 24 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kristina K Hardy Children's Oncology Group
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01503086    
Other Study ID Numbers: 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 )
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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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
Additional relevant MeSH terms:
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Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases