Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02153957 : Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors
PhasePhase 2
AgesMin: 8 Years Max: 18 Years
Eligibility
- INCLUSION CRITERIA:

1. Children ages 8 - 18 years of age, diagnosed with brain tumor in childhood.

2. Must be at least 1 year post completion of radiation therapy to the brain or
brain and spine.

3. Must be off anti-neoplastic therapy for at least 2 weeks and all therapy-related
toxicities should return to baseline or less than or equal to Grade 1 if
previously nonexistent.

4. Have parent-reported or documented difficulties in attention, processing speed,
memory, or learning as assessed by the screening questions (a score of at least 3
on any one of the 4 questions or the participant having greater than or equal to
1/2 SD decline in test scores, scores < 85, or special education services or
accommodations).

5. Must have a parent or legal guardian willing to complete the parent proxy
behavioral questionnaires and help their child participate in the study
procedures at home.

6. Ability to read and understand the English language.

7. Have regular access to a computer (either PC or Mac with a built-in USB port).

8. Must be willing to register online and install the software to use an
age-appropriate activity monitor and website which will include sharing some
personal identifiable information, to allow the participant to track their
physical activity.

9. Ability of subject or Legally Authorized Representative (LAR) to understand and
willingness to sign a written informed consent document.

EXCLUSION CRITERIA

1. A child with diffuse intrinsic pontine glioma (DIPG) or recurrent high grade brain
tumors will be excluded due to the poor prognosis, making participation for the length
of this study difficult.

2. Significant medical problems, such as severe uncontrolled illnesses, or physical
impairments that prohibit the child from exercising at moderate to vigorous levels
based on the clinical judgment of the examining physician or nurse practitioner.

3. Currently engaging in > 3 hours of moderate to vigorous physical activity per week, as
reported in the exercise screening questions completed at the pre-study screening
evaluation.

4. Significant cognitive, behavioral, or emotional impairments as judged by an
investigator that would prevent the child from understanding or completing the
intervention or assessment measures.

5. A child has plans to start a new treatment for attention/memory problems in the next 3
months.

6. Currently on or planning to begin active neoplastic therapy, as the side effects may
significantly impair ability to participate in physical activity.

7. Unable to travel to NIH for the evaluations.
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02153957      |      Link to official Clinicaltrials.gov listing
Locations
Bethesda, Maryland
Facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
Investigator:
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office Phone: 888-624-1937
Email not avaialable




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