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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

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ClinicalTrials.gov Identifier: NCT02153957
Recruitment Status : Recruiting
First Posted : June 3, 2014
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief 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.

Condition or disease Intervention/treatment Phase
Brain Tumor Behavioral: Physical Activity Phase 2

  Show Detailed Description

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 ChildrenTreated With Cranial Radiation for BrainTumors
Study Start Date : May 31, 2014
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Enhanced PA home intervention group for the first 12weeks; followed by 12 weeks of PA maintenance ontheir own.
Behavioral: Physical Activity
12 weeks of enhanced physical activity with Zamzee monitor.

2
Usual physical activity (no intervention) for 12 weeks;followed by the enhanced PA home intervention for 12 weeks.
Behavioral: Physical Activity
12 weeks of enhanced physical activity with Zamzee monitor.




Primary Outcome Measures :
  1. Efficacy [ Time Frame: 12 weeks ]
    Efficacy of 12-weeks PA on visual memory


Secondary Outcome Measures :
  1. Examine test scores pre- to post- intervention [ Time Frame: 24 weeks ]
    Examine test scores pre- to post- intervention

  2. Compare cognitive test scores between groups [ Time Frame: 12 weeks ]
    Compare cognitive test scores between groups

  3. Effects of lab treadmill on cognitive functioning [ Time Frame: 2 days ]
    Effects of lab treadmill on cognitive functioning

  4. Effects of 12wk PA on circulating growth factors [ Time Frame: 12 weeks ]
    Effects of 12wk PA on circulating growth factors

  5. Effects of 12wk PA on fatigue and QOL [ Time Frame: 24 weeks ]
    Effects of 12wk PA on fatigue and QOL

  6. Effects of 12wk PA on cognitive functions [ Time Frame: 24 weeks ]
    Effects of 12wk PA on cognitive functions

  7. Examine circulating growth factors with PA levels & fitness [ Time Frame: 4 years ]
    Examine circulating growth factors with PA levels & fitness

  8. 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



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (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.

Information from the National Library of Medicine

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


Contacts
Contact: Pamela L Wolters, Ph.D. (240) 760-6035 woltersp@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Pamela L Wolters, Ph.D. National Cancer Institute (NCI)

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02153957     History of Changes
Other Study ID Numbers: 140116
14-C-0116
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: July 30, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Exercise
Memory
BDNF
Zamzee
QOL

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases