Clinical trial NCT01503086: Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy
Official title: Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Brain Neoplasm
Recurrent Brain Neoplasm
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-02
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Intervention compliance
timeFrame: Up to 9 weeks of starting training
Secondary outcomes:
Other outcomes:
measure: Parent-rated executive function using the Metacognition subscales from the Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: Up to 6 months post training completion
measure: Working memory (WM) using the Metacognition subscales from (BRIEF)
timeFrame: Up to 6 months post training completion
measure: Executive function using the Groton Maze Learning task of the CogState battery
timeFrame: Up to 6 months post training completion
measure: WM by the one-back task from CogState
timeFrame: Up to 6 months post training completion
measure: WM by Digit Span from Wechsler Intelligence Scales
timeFrame: Up to 6 months post training completion
measure: Visual working memory using Spatial Span from Wechsler Scale
timeFrame: Up to 6 months post training completion
measure: Visual memory using Dot Location from Children's Memory Scale
timeFrame: Up to 6 months post training completion
measure: Technical feasibility based on the item responses to the 13-item Feasibility Interview
timeFrame: Up to 6 months post training completion
measure: Adherence based on total number of training sessions completed
timeFrame: Up to 6 months post training completion
measure: Satisfaction based on the item responses to the 13-item Feasibility Interview
timeFrame: Up to 6 months post training completion
measure: Ease of use based on the item responses to the 13-item Feasibility Interview
timeFrame: Up to 6 months post training completion
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Wilmington
country: United States
facility: Alfred I duPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Fort Myers
country: United States
facility: Golisano Children's Hospital of Southwest Florida
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic-Jacksonville
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Arthur M Blank Hospital
state: Georgia
city: Boise
country: United States
facility: Saint Luke's Cancer Institute - Boise
state: Idaho
city: Des Moines
country: United States
facility: Blank Children's Hospital
state: Iowa
city: Ann Arbor
country: United States
facility: C S Mott Children's Hospital
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: East Tennessee Childrens Hospital
state: Tennessee
city: Memphis
country: United States
facility: Saint Jude Children's Research Hospital
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern/Simmons Cancer Center-Dallas
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center and Children's Hospital
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center - University Hospital
state: Wisconsin
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Children's Oncology Group
name: Kristina K Hardy
role: PRINCIPAL_INVESTIGATOR
References: