Trial Title:
Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy
NCT ID:
NCT01503086
Condition:
Brain Neoplasm
Recurrent Brain Neoplasm
Conditions: Official terms:
Neoplasms
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Cognitive Assessment
Description:
Ancillary studies
Arm group label:
Arm I (interactive training program)
Arm group label:
Arm II (non-adaptive training program)
Intervention type:
Other
Intervention name:
Computer-Assisted Cognitive Training
Description:
Receive computer-assisted cognitive training
Arm group label:
Arm I (interactive training program)
Arm group label:
Arm II (non-adaptive training program)
Intervention type:
Procedure
Intervention name:
Psychosocial Assessment and Care
Description:
Ancillary studies
Arm group label:
Arm I (interactive training program)
Arm group label:
Arm II (non-adaptive training program)
Other name:
Psychosocial Care/Assessment
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Arm I (interactive training program)
Arm group label:
Arm II (non-adaptive training program)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (interactive training program)
Arm group label:
Arm II (non-adaptive training program)
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
6 Years
Maximum age:
16 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Hospital Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Facility:
Name:
Alfred I duPont Hospital for Children
Address:
City:
Wilmington
Zip:
19803
Country:
United States
Facility:
Name:
Children's National Medical Center
Address:
City:
Washington
Zip:
20010
Country:
United States
Facility:
Name:
Broward Health Medical Center
Address:
City:
Fort Lauderdale
Zip:
33316
Country:
United States
Facility:
Name:
Golisano Children's Hospital of Southwest Florida
Address:
City:
Fort Myers
Zip:
33908
Country:
United States
Facility:
Name:
Nemours Children's Clinic-Jacksonville
Address:
City:
Jacksonville
Zip:
32207
Country:
United States
Facility:
Name:
Nemours Children's Hospital
Address:
City:
Orlando
Zip:
32827
Country:
United States
Facility:
Name:
Tampa General Hospital
Address:
City:
Tampa
Zip:
33606
Country:
United States
Facility:
Name:
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Address:
City:
Atlanta
Zip:
30329
Country:
United States
Facility:
Name:
Saint Luke's Cancer Institute - Boise
Address:
City:
Boise
Zip:
83712
Country:
United States
Facility:
Name:
Blank Children's Hospital
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Facility:
Name:
C S Mott Children's Hospital
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Facility:
Name:
Children's Mercy Hospitals and Clinics
Address:
City:
Kansas City
Zip:
64108
Country:
United States
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
Albany Medical Center
Address:
City:
Albany
Zip:
12208
Country:
United States
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Facility:
Name:
Wake Forest University Health Sciences
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Facility:
Name:
East Tennessee Childrens Hospital
Address:
City:
Knoxville
Zip:
37916
Country:
United States
Facility:
Name:
Saint Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Facility:
Name:
UT Southwestern/Simmons Cancer Center-Dallas
Address:
City:
Dallas
Zip:
75390
Country:
United States
Facility:
Name:
University of Texas Health Science Center at San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Facility:
Name:
Virginia Commonwealth University/Massey Cancer Center
Address:
City:
Richmond
Zip:
23298
Country:
United States
Facility:
Name:
Seattle Children's Hospital
Address:
City:
Seattle
Zip:
98105
Country:
United States
Facility:
Name:
Providence Sacred Heart Medical Center and Children's Hospital
Address:
City:
Spokane
Zip:
99204
Country:
United States
Facility:
Name:
University of Wisconsin Carbone Cancer Center - University Hospital
Address:
City:
Madison
Zip:
53792
Country:
United States
Facility:
Name:
Hospital for Sick Children
Address:
City:
Toronto
Zip:
M5G 1X8
Country:
Canada
Start date:
February 19, 2015
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Children's Oncology Group
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Children's Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01503086
