Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT02153957
Eligibility Criteria:
* 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 a tablet, or a smartphone (the device must have either a USB port or Bluetooth with internet capability).
8. Must be willing to register online and install the software to use an age-appropriate activity monitor and website/app which will include sharing some personal identifiable information, to allow the participant to track their physical activity.
9. Ability of subject or parent/guardian to understand and willingness to sign a written informed consent document.
PARENT OR GURADIAN OF PARTICIPATING SUBJECT:
1. Parent or Guardian of participating subject
2. Ability to understand and willingness to sign a written informed consent document
3. Ability to read and understand the English language.
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 or unwilling to travel to NIH or DFCI/BCH for the evaluations.
8. History of medical non-compliance or difficulty completing previous required study tasks or visits that suggest the participant would not follow through with the home study procedures.
PARENT OR GUARDIAN EXCLUSION CRITERIA:
1\. Parent or guardian of an ineligible subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT02153957
Study Brief:
Protocol Section:
NCT02153957