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

Brain Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01503086
• Other study ID #: ACCL10P1
• Secondary ID: NCI-2012-00112CO
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 19, 2015
• Est. completion date: March 30, 2027

Study information

• Verified date: May 2024
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: March 30, 2027
• Est. primary completion date: March 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasm
• Brain Neoplasms
• Neoplasms
• Recurrent Brain Neoplasm

Intervention

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
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
United States	Albany Medical Center	Albany	New York
United States	C S Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta - Egleston	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Saint Luke's Cancer Institute - Boise	Boise	Idaho
United States	Medical University of South Carolina	Charleston	South Carolina
United States	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas
United States	Blank Children's Hospital	Des Moines	Iowa
United States	Duke University Medical Center	Durham	North Carolina
United States	Broward Health Medical Center	Fort Lauderdale	Florida
United States	Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida
United States	Nemours Children's Clinic-Jacksonville	Jacksonville	Florida
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	East Tennessee Childrens Hospital	Knoxville	Tennessee
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	Saint Jude Children's Research Hospital	Memphis	Tennessee
United States	Nemours Children's Hospital	Orlando	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Seattle Children's Hospital	Seattle	Washington
United States	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington
United States	Tampa General Hospital	Tampa	Florida
United States	Children's National Medical Center	Washington	District of Columbia
United States	Alfred I duPont Hospital for Children	Wilmington	Delaware
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parent-rated executive function using the Metacognition subscales from the Behavior Rating Inventory of Executive Function (BRIEF)	Descriptive/summary statistics will be provided.	Up to 6 months post training completion
Other	Working memory (WM) using the Metacognition subscales from (BRIEF)	Descriptive/summary statistics will be provided.	Up to 6 months post training completion
Other	Executive function using the Groton Maze Learning task of the CogState battery	Descriptive/summary statistics will be provided.	Up to 6 months post training completion
Other	WM by the one-back task from CogState	Descriptive/summary statistics will be provided.	Up to 6 months post training completion
Other	WM by Digit Span from Wechsler Intelligence Scales	Descriptive/summary statistics will be provided.	Up to 6 months post training completion
Other	Visual working memory using Spatial Span from Wechsler Scale	Descriptive/summary statistics will be provided.	Up to 6 months post training completion
Other	Visual memory using Dot Location from Children's Memory Scale	Descriptive/summary statistics will be provided.	Up to 6 months post training completion
Other	Technical feasibility based on the item responses to the 13-item Feasibility Interview	Descriptive/summary statistics will be provided.	Up to 6 months post training completion
Other	Adherence based on total number of training sessions completed	Descriptive/summary statistics will be provided.	Up to 6 months post training completion
Other	Satisfaction based on the item responses to the 13-item Feasibility Interview	Descriptive/summary statistics will be provided.	Up to 6 months post training completion
Other	Ease of use based on the item responses to the 13-item Feasibility Interview	Descriptive/summary statistics will be provided.	Up to 6 months post training completion
Primary	Proportion of patients with intervention compliance	Intervention compliance defined as at least 80% of sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training).	Up to 9 weeks of starting training