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

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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 16 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01503086
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Children's Oncology Group
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kristina K Hardy
Principal Investigator Affiliation	Children's Oncology Group
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Active, not recruiting
Countries	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Neoplasm, Recurrent Brain Neoplasm

Additional Details

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.

Arms & Interventions

Arms

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.

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

Ancillary studies

Other: - Computer-Assisted Cognitive Training

Receive computer-assisted cognitive training

Procedure: - Psychosocial Assessment and Care

Ancillary studies

Other: - Quality-of-Life Assessment

Ancillary studies

Other: - Questionnaire Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Colorado, Aurora 5412347, Colorado 5417618

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Children's Hospital Colorado

Aurora 5412347, Colorado 5417618, 80045

Alfred I duPont Hospital for Children, Wilmington 4145381, Delaware 4142224

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Address

Alfred I duPont Hospital for Children

Wilmington 4145381, Delaware 4142224, 19803

Children's National Medical Center, Washington D.C. 4140963, District of Columbia 4138106

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Children's National Medical Center

Washington D.C. 4140963, District of Columbia 4138106, 20010

Broward Health Medical Center, Fort Lauderdale 4155966, Florida 4155751

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Broward Health Medical Center

Fort Lauderdale 4155966, Florida 4155751, 33316

Fort Myers 4155995, Florida 4155751

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Golisano Children's Hospital of Southwest Florida

Fort Myers 4155995, Florida 4155751, 33908

Nemours Children's Clinic-Jacksonville, Jacksonville 4160021, Florida 4155751

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Nemours Children's Clinic-Jacksonville

Jacksonville 4160021, Florida 4155751, 32207

Nemours Children's Hospital, Orlando 4167147, Florida 4155751

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Nemours Children's Hospital

Orlando 4167147, Florida 4155751, 32827

Tampa General Hospital, Tampa 4174757, Florida 4155751

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Tampa General Hospital

Tampa 4174757, Florida 4155751, 33606

Atlanta 4180439, Georgia 4197000

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Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta 4180439, Georgia 4197000, 30329

Saint Luke's Cancer Institute - Boise, Boise 5586437, Idaho 5596512

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Saint Luke's Cancer Institute - Boise

Boise 5586437, Idaho 5596512, 83712

Blank Children's Hospital, Des Moines 4853828, Iowa 4862182

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Blank Children's Hospital

Des Moines 4853828, Iowa 4862182, 50309

C S Mott Children's Hospital, Ann Arbor 4984247, Michigan 5001836

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C S Mott Children's Hospital

Ann Arbor 4984247, Michigan 5001836, 48109

Children's Mercy Hospitals and Clinics, Kansas City 4393217, Missouri 4398678

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Children's Mercy Hospitals and Clinics

Kansas City 4393217, Missouri 4398678, 64108

Washington University School of Medicine, St Louis 4407066, Missouri 4398678

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Washington University School of Medicine

St Louis 4407066, Missouri 4398678, 63110

Albany Medical Center, Albany 5106834, New York 5128638

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Albany Medical Center

Albany 5106834, New York 5128638, 12208

Duke University Medical Center, Durham 4464368, North Carolina 4482348

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Duke University Medical Center

Durham 4464368, North Carolina 4482348, 27710

Wake Forest University Health Sciences, Winston-Salem 4499612, North Carolina 4482348

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Wake Forest University Health Sciences

Winston-Salem 4499612, North Carolina 4482348, 27157

Children's Hospital of Philadelphia, Philadelphia 4560349, Pennsylvania 6254927

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Children's Hospital of Philadelphia

Philadelphia 4560349, Pennsylvania 6254927, 19104

Medical University of South Carolina, Charleston 4574324, South Carolina 4597040

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Medical University of South Carolina

Charleston 4574324, South Carolina 4597040, 29425

East Tennessee Childrens Hospital, Knoxville 4634946, Tennessee 4662168

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East Tennessee Childrens Hospital

Knoxville 4634946, Tennessee 4662168, 37916

Saint Jude Children's Research Hospital, Memphis 4641239, Tennessee 4662168

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Saint Jude Children's Research Hospital

Memphis 4641239, Tennessee 4662168, 38105

Dallas 4684888, Texas 4736286

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UT Southwestern/Simmons Cancer Center-Dallas

Dallas 4684888, Texas 4736286, 75390

San Antonio 4726206, Texas 4736286

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University of Texas Health Science Center at San Antonio

San Antonio 4726206, Texas 4736286, 78229

Richmond 4781708, Virginia 6254928

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Virginia Commonwealth University/Massey Cancer Center

Richmond 4781708, Virginia 6254928, 23298

Seattle Children's Hospital, Seattle 5809844, Washington 5815135

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Seattle Children's Hospital

Seattle 5809844, Washington 5815135, 98105

Spokane 5811696, Washington 5815135

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Providence Sacred Heart Medical Center and Children's Hospital

Spokane 5811696, Washington 5815135, 99204

Madison 5261457, Wisconsin 5279468

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University of Wisconsin Carbone Cancer Center - University Hospital

Madison 5261457, Wisconsin 5279468, 53792

International Sites

Hospital for Sick Children, Toronto 6167865, Ontario 6093943, Canada

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Address

Hospital for Sick Children

Toronto 6167865, Ontario 6093943, M5G 1X8

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