Trial Outcomes & Findings for Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy (NCT NCT01503086)

Last Updated: 2025-12-05

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

45 participants

Primary outcome timeframe

Up to 9 weeks of starting training

Results posted on

2025-12-05

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.	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.	No Assigned Arm Patients never assigned to a treatment arm.
Overall Study STARTED	21	21	3
Overall Study COMPLETED	11	11	0
Overall Study NOT COMPLETED	10	10	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	No Assigned Arm Patients never assigned to a treatment arm.
Overall Study Lost to Follow-up	0	1	0
Overall Study Did Not Start Treatment	4	3	3
Overall Study Progressive disease	3	1	0
Overall Study Patient did not complete cognitive training within 9 weeks	3	3	0
Overall Study Refusal of further protocol therapy by patient/parent/guardian	0	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Interactive Training Program) n=21 Participants 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.	Arm II (Non-adaptive Training Program) n=21 Participants 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.	No Assigned Arm n=3 Participants Patients never assigned to a treatment arm.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	21 Participants n=37 Participants	21 Participants n=37 Participants	3 Participants n=74 Participants	45 Participants n=267 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants
Age, Categorical >=65 years	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants
Age, Continuous	10.7 years STANDARD_DEVIATION 2.7 • n=37 Participants	10.6 years STANDARD_DEVIATION 3 • n=37 Participants	11.7 years STANDARD_DEVIATION 2.9 • n=74 Participants	10.7 years STANDARD_DEVIATION 2.8 • n=267 Participants
Sex: Female, Male Female	7 Participants n=37 Participants	7 Participants n=37 Participants	1 Participants n=74 Participants	15 Participants n=267 Participants
Sex: Female, Male Male	14 Participants n=37 Participants	14 Participants n=37 Participants	2 Participants n=74 Participants	30 Participants n=267 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=37 Participants	2 Participants n=37 Participants	0 Participants n=74 Participants	4 Participants n=267 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=37 Participants	18 Participants n=37 Participants	3 Participants n=74 Participants	35 Participants n=267 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=37 Participants	1 Participants n=37 Participants	0 Participants n=74 Participants	6 Participants n=267 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Asian	2 Participants n=37 Participants	2 Participants n=37 Participants	0 Participants n=74 Participants	4 Participants n=267 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Black or African American	3 Participants n=37 Participants	0 Participants n=37 Participants	1 Participants n=74 Participants	4 Participants n=267 Participants
Race (NIH/OMB) White	11 Participants n=37 Participants	17 Participants n=37 Participants	2 Participants n=74 Participants	30 Participants n=267 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	1 Participants n=37 Participants	0 Participants n=74 Participants	1 Participants n=267 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=37 Participants	1 Participants n=37 Participants	0 Participants n=74 Participants	6 Participants n=267 Participants
Region of Enrollment Canada	5 participants n=37 Participants	4 participants n=37 Participants	0 participants n=74 Participants	9 participants n=267 Participants
Region of Enrollment United States	16 participants n=37 Participants	17 participants n=37 Participants	3 participants n=74 Participants	36 participants n=267 Participants

PRIMARY outcome

Timeframe: 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)."