Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors
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ClinicalTrials.gov Identifier: NCT02153957 |
Recruitment Status :
Recruiting
First Posted : June 3, 2014
Last Update Posted : April 17, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
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Brain Tumor | Behavioral: Physical Activity | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 156 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Randomized Controlled Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors |
Actual Study Start Date : | August 21, 2014 |
Estimated Primary Completion Date : | June 30, 2025 |
Estimated Study Completion Date : | June 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
enhanced PA home intervention group for the first 12 weeks; followed by 12 weeks of PA maintenance on their own.
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Behavioral: Physical Activity
12 weeks of enhanced physical activity with Zamzee monitor. |
Active Comparator: 2
usual physical activity (no intervention) for 12 weeks; followed by the enhanced PA home intervention for 12 weeks.
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Behavioral: Physical Activity
12 weeks of enhanced physical activity with Zamzee monitor. |
- Efficacy [ Time Frame: 12 weeks ]Efficacy of 12-weeks PA on visual memory
- feasibility [ Time Frame: 4 years ]To assess the feasibility of various components of the intervention (e.g., ACT sessions, PA monitors) based on the post-study questionnaire/interview and explore relationships between the use of these components and physical activity outcomes
- examine test scores pre- to post-intervention [ Time Frame: 24 weeks ]examine test scores pre- to post-intervention
- effects of lab treadmill on neurobehavioral functioning [ Time Frame: 2 days ]effects of lab treadmill on neurobehavorial functioning
- effects of 12wk PA on fatigue, sleep and QOL [ Time Frame: 24 weeks ]effects of 12wk PA on fatigue, sleep, and QOL
- effects of 12wk PA on cognitive functions [ Time Frame: 24 weeks ]effects of 12wk PA on cognitive functions
- compare cognitive test scores between groups [ Time Frame: 12 weeks ]compare cognitive test scores between groups
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 8 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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INCLUSION CRITERIA:
- Children ages 8 - 18 years of age, diagnosed with brain tumor in childhood.
- Must be at least 1 year post completion of radiation therapy to the brain or brain and spine.
- 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.
- 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).
- 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.
- Ability to read and understand the English language.
- Have regular access to a computer a tablet, or a smartphone (the device must have either a USB port or Bluetooth with internet capability).
- 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.
- Ability of subject or parent/guardian to understand and willingness to sign a written informed consent document.
PARENT OR GURADIAN OF PARTICIPATING SUBJECT:
- Parent or Guardian of participating subject
- Ability to understand and willingness to sign a written informed consent document
- Ability to read and understand the English language.
EXCLUSION CRITERIA
- 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.
- 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.
- 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.
- 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.
- A child has plans to start a new treatment for attention/memory problems in the next 3 months.
- Currently on or planning to begin active neoplastic therapy, as the side effects may significantly impair ability to participate in physical activity.
- Unable or unwilling to travel to NIH or DFCI/BCH for the evaluations.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153957
Contact: Pamela L Wolters, Ph.D. | (240) 760-6035 | woltersp@mail.nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937 |
Principal Investigator: | Pamela L Wolters, Ph.D. | National Cancer Institute (NCI) |
Publications:
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT02153957 |
Other Study ID Numbers: |
140116 14-C-0116 |
First Posted: | June 3, 2014 Key Record Dates |
Last Update Posted: | April 17, 2024 |
Last Verified: | October 23, 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | .All IPD recorded in the medical record will be shared with intramural investigators upon request. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | Clinical data available during the study and indefinitely. |
Access Criteria: | Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Exercise Memory BDNF Zamzee QOL |
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |