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


N/A
6 Years
16 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity

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Trial Information

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


OBJECTIVES:

- 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.

- 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. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to known risk
factors including age (< 8 years vs ≥ 8 years), treatment intensity (whole brain vs focal
radiation). Patients are randomized to 1 of 2 intervention 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Patient must be newly diagnosed (i.e., not relapsed) with a brain tumor; patients
with pontine glioma are not eligible

- Patients with a history of traumatic brain injury prior to tumor diagnosis are not
eligible

- Patients with a tumor relapse or disease progression are not eligible to participate
in this trial

PATIENT CHARACTERISTICS:

- Patient is currently being followed at 1 of the participating sites

- Patients diagnosed with any Axis I mental health disorder (e.g., depression) that, in
the examining psychologist's opinion, would preclude or take treatment precedence
over participation in computerized training will not be eligible

- The patient must have an identified caregiver who is willing and able to oversee the
training practice during the intervention period (i.e., for 5-9 weeks starting
approximately 3 months after completion of cranial radiation therapy [CRT]).

- The patient and caregiver must have reading, speaking, and listening comprehension of
English

- Patients with photosensitive seizures are not eligible to participate in this trial

- 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

PRIOR CONCURRENT THERAPY:

- Patient is within three (3) ± one (1) calendar months following completion of cranial
radiation therapy (CRT)

- Must not start or change dosage of psychostimulant medications during the study
period

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Intervention compliance defined as at least 80% of sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training)

Safety Issue:

No

Principal Investigator

Kristina Hardy, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Research Institute

Authority:

Unspecified

Study ID:

CDR0000721387

NCT ID:

NCT01503086

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Cognitive/Functional Effects
  • Neurotoxicity
  • Psychosocial Effects of Cancer and Its Treatment
  • Radiation Toxicity
  • neurotoxicity
  • radiation toxicity
  • cognitive/functional effects
  • psychosocial effects of cancer and its treatment
  • childhood brain tumor
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neurotoxicity Syndromes
  • Radiation Injuries

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