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

Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01503086

Enrollment

Registered

2012-01-02

Start date

2014-07-30

Completion date

2026-03-31

Last updated

2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasm, Recurrent Brain Neoplasm

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.

Interventions

PROCEDURECognitive Assessment

Ancillary studies

OTHERComputer-Assisted Cognitive Training

Receive computer-assisted cognitive training

PROCEDUREPsychosocial Assessment and Care

Ancillary studies

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Intervention Compliance	Up to 9 weeks of starting training	Intervention compliance is defined as at least 80% of computerized training sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training). Will report the proportion of eligible, randomized patients who meet the compliance definition by arm with corresponding 95% confidence intervals.

Countries

Canada, United States

Contacts

PRINCIPAL_INVESTIGATORKristina K Hardy

Children's Oncology Group

Participant flow

Pre-assignment details

There were 45 total enrollments, among which 3 were never assigned to a treatment arm.

Participants by arm

Arm	Count
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.	21
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.	21
No Assigned Arm Patients never assigned to a treatment arm.	3
Total	45

Baseline characteristics

Characteristic	Arm I (Interactive Training Program)	Arm II (Non-adaptive Training Program)	No Assigned Arm	Total
Age, Categorical <=18 years	21 Participants	21 Participants	3 Participants	45 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Continuous	10.7 years STANDARD_DEVIATION 2.7	10.6 years STANDARD_DEVIATION 3	11.7 years STANDARD_DEVIATION 2.9	10.7 years STANDARD_DEVIATION 2.8
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	2 Participants	0 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants	18 Participants	3 Participants	35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants	1 Participants	0 Participants	6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	2 Participants	0 Participants	4 Participants
Race (NIH/OMB) Black or African American	3 Participants	0 Participants	1 Participants	4 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants	1 Participants	0 Participants	6 Participants
Race (NIH/OMB) White	11 Participants	17 Participants	2 Participants	30 Participants
Region of Enrollment Canada	5 participants	4 participants	0 participants	9 participants
Region of Enrollment United States	16 participants	17 participants	3 participants	36 participants
Sex: Female, Male Female	7 Participants	7 Participants	1 Participants	15 Participants
Sex: Female, Male Male	14 Participants	14 Participants	2 Participants	30 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 21	0 / 3
other Total, other adverse events	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0

Outcome results

Primary

Intervention Compliance

Intervention compliance is defined as at least 80% of computerized training sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training). Will report the proportion of eligible, randomized patients who meet the compliance definition by arm with corresponding 95% confidence intervals.

Time frame: Up to 9 weeks of starting training

Population: Per protocol, the analysis includes all eligible, randomized participants without a medical event during cognitive training (cancer relapse/progression, death, removal from protocol therapy due to physician's determination in the patient's best interest, development of seizures or other change in functional status, or starting or changing the dose of psychostimulants).~dose of psychostimulants).

Arm	Measure	Value (NUMBER)
Arm I (Interactive Training Program)	Intervention Compliance	0.39 Proportion of Participants
Arm II (Non-adaptive Training Program)	Intervention Compliance	0.50 Proportion of Participants

Other Pre-specified