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

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ClinicalTrials.gov Identifier: NCT01503086
Recruitment Status : Recruiting
First Posted : January 2, 2012
Last Update Posted : October 18, 2018
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.


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. 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. Fisher?s exact test will be used to examine if there is any significant difference in the compliance rate between the 2 arms. Compliance data on the number of sessions completed for all patients and for patients on each arm will also be 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 :
  1. Parent-rated executive function and working memory (WM) using the Metacognition subscales from the Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Up to 6 months ]
    Will use descriptive/summary statistics to summarize the objective and the subjective measures of attention and WM in each arm and the differences between the 2 arms. Linear regression models using the post-intervention/6-month assessment as outcome will also be used to estimate the effect size of intervention with adjustment for potential confounders including the baseline assessment. Linear mixed model analyses which include measures at all time-points will also be considered to examine and estimate the effect size of the intervention with adjustment for within-patient dependence of the measures over time.

  2. Executive function using the Groton Maze Learning task of the CogState battery [ Time Frame: Up to 6 months ]
    Will use descriptive/summary statistics to summarize the objective and the subjective measures of attention and WM in each arm and the differences between the 2 arms. Linear regression models using the post-intervention/6-month assessment as outcome will also be used to estimate the effect size of intervention with adjustment for potential confounders including the baseline assessment. Linear mixed model analyses which include measures at all time-points will also be considered to examine and estimate the effect size of the intervention with adjustment for within-patient dependence of the measures over time.

  3. WM by the one-back task from CogState and Digit Span from Wechsler Intelligence Scales [ Time Frame: Up to 6 months ]
    Will use descriptive/summary statistics to summarize the objective and the subjective measures of attention and WM in each arm and the differences between the 2 arms. Linear regression models using the post-intervention/6-month assessment as outcome will also be used to estimate the effect size of intervention with adjustment for potential confounders including the baseline assessment. Linear mixed model analyses which include measures at all time-points will also be considered to examine and estimate the effect size of the intervention with adjustment for within-patient dependence of the measures over time.

  4. Verbal and visual memory using Dot Location from Children?s Memory Scale Spatial Span from Wechsler Scale [ Time Frame: Up to 6 months ]
    Will use descriptive/summary statistics to summarize the objective and the subjective measures of attention and WM in each arm and the differences between the 2 arms. Linear regression models using the post-intervention/6-month assessment as outcome will also be used to estimate the effect size of intervention with adjustment for potential confounders including the baseline assessment. Linear mixed model analyses which include measures at all time-points will also be considered to examine and estimate the effect size of the intervention with adjustment for within-patient dependence of the measures over time.

  5. Technical feasibility based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months ]
    Will use descriptive and summary statistics to report parent and child ratings across the three time-points that this information is collected.

  6. Adherence [ Time Frame: Up to 6 months ]
  7. Satisfaction and ease of use [ Time Frame: Up to 6 months ]
    Will use descriptive and summary statistics to report parent and child ratings across the three time-points that this information is collected.



Information from the National Library of Medicine

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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
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Kathleen M. Dorris         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jeffrey S. Dome         
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Wendy L. Woods-Swafford         
United States, Michigan
C S Mott Children's Hospital Active, not recruiting
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Allison A. King         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Public Contact    888-275-3853      
Principal Investigator: Susan G. Kreissman         
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Wayne L. Furman         
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: Naomi J. Winick         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    210-450-3800    phoresearchoffice@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Active, not recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Judy L. Felgenhauer         
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Site Public Contact    416-813-7654 ext 2027    jason.mcguire@sickkids.ca   
Principal Investigator: Donald Mabbott         
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kristina Hardy Children's Oncology Group

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
COG-ACCL10P1
ACCL10P1 ( Other Identifier: Childrens 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 18, 2018
Last Verified: September 2018

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