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NCT02153957 · ClinicalTrials.gov registry record · Phase 2
Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT02153957: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02153957 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02153957, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
Background: \- More children with cancer are surviving into adulthood. Some side effects from treatment go away quickly. But some problems may not go away or may only show up months or years later. These problems are called late effects. Late effects can cause difficulties in cognitive functions, such as attention and memory. Physical activity has been found to improve the attention and memory skills of children with Attention Deficit Hyperactivity Disorder (ADHD). Researchers want to see if physical activity can help with these cognitive problems in children with brain tumors. Objectives: \- To see if physical activity can improve cognitive functions in children who had radiation therapy for a brain tumor. Eligibility: \- Children ages 8 17 who had radiation for a brain tumor at least 2 years ago. They must have access to a computer. Design: * Participants will be screened with height, weight, and medical history. They will answer questions about daily physical activities. Their heart will be checked. * Participants will go to the clinic for 2 days. They will have a fitness exam and tests about attention, memory, and concentration. They will have blood taken and answer questions. Parents will also answer questions. * Participants will be put into 2 groups. For the first 12 weeks, the intervention group will follow a physical activity program. The control group will do their usual physical activities. * For the second 12 weeks, the control group will follow the physical activity program. The intervention group will continue the activities on their own. All groups will track their physical activity with an activity monitor and computer. * Participants will have a follow-up visit at the clinic after each session. They will repeat some of the tests listed above. * The study lasts 24 weeks plus the two follow-up visits. Participants can keep their activity monitor.
Interventions
- BEHAVIORAL Physical Activity
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-08-21 |
| Est. Completion | 2023-02-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02153957
The ClinicalTrials.gov registry entry for NCT02153957 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Physical Activity is the first listed.
NCT02153957 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02153957 about?
NCT02153957 is a clinical study titled "Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors". Background: \- More children with cancer are surviving into adulthood. Some side effects from treatment go away quickly. But some problems may not go away or may only show up months or years later. These problems are called late effects. Late effects can cause difficulties in cognitive functions, s...
What is the current status of trial NCT02153957?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2014-08-21. Estimated completion is 2023-02-14.
What interventions are being tested in trial NCT02153957?
The interventions under investigation include: Physical Activity (BEHAVIORAL).
Who is sponsoring clinical trial NCT02153957?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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