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Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors

NCT02153957 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-08

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

Physical Activity

12 weeks of enhanced physical activity with Zamzee monitor.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Pamela L Wolters, Ph.D. · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-21
Primary Completion
2023-02-14
Completion
2023-02-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02153957 on ClinicalTrials.gov