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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 : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date  ICMJE May 31, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date June 16, 2021
Actual Study Start Date  ICMJE August 21, 2014
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
Efficacy [ Time Frame: 12 weeks ]
Efficacy of 12-weeks PA on visual memory
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2014)
Efficacy of 12-weeks PA on visual memory [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • 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 neurobehavioral functioning
  • compare cognitive test scores between groups [ Time Frame: 12 weeks ]
    compare cognitive test scores between groups
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2014)
  • Examine test scores pre- to post- intervention [ Time Frame: 24 weeks ]
  • compare cognitive test scores between groups [ Time Frame: 12 weeks ]
  • Effects of lab treadmill on cognitive functioning [ Time Frame: 2 days ]
  • Effects of 12wk PA on circulating growth factors [ Time Frame: 12 weeks ]
  • Effects of 12wk PA on fatigue and QOL [ Time Frame: 24 weeks ]
  • Effects of 12wk PA on cognitive functions [ Time Frame: 24 weeks ]
  • Examine circulating growth factors with PA levels & amp; fitness [ Time Frame: 4 years ]
  • Feasibility [ Time Frame: 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors
Official Title  ICMJE A Randomized Controlled Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in ChildrenTreated With Cranial Radiation for BrainTumors
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.
Detailed Description

BACKGROUND:

  • Children treated with cranial radiation therapy (CRT) for brain tumors are at high risk for developing neurocognitive late effects consisting of significant declines in overall IQ and specific cognitive impairments, particularly in attention, memory, and processing speed. Academic functioning, daily activities, and quality of life (QOL) also are impacted, and children often require special educational services.
  • Despite adaptations in radiation therapy (delay of radiation, reduced dose, specialized techniques), cognitive deficits still develop. Interventions targeting cognitive rehabilitation are limited yet sorely needed.
  • A potential and novel intervention for cognitive rehabilitation that has not been explored in children with cancer involves physical activity (PA). Compelling evidence from both human and animal studies indicates that PA affects the same brain mechanisms and cognitive functions damaged by CRT and chemotherapy.
  • Previous PA intervention studies in children with cancer have been found to be feasible, safe, and beneficial to health but have not examined cognition outcomes. Therefore, we will conduct a randomized controlled trial to evaluate the effects of PA on the cognitive functioning of children treated with CRT for brain tumors. In addition, we will enhance the intervention by combining it with Acceptance and Commitment Therapy (ACT) techniques to maximize participants' motivation to engage in PA.
  • The immediate intervention group (the intervention group ) will engage in the enhanced PA intervention program for the first 12 weeks followed by 12 weeks of PA maintenance on their own, while the delayed intervention control group (the control group ) will engage in their usual physical activity for the first 12 weeks followed by the enhanced PA intervention program for the second 12 weeks.

OBJECTIVES:

-To assess the effects of a 12-week enhanced physical activity (PA) home intervention on visual memory (CogState One Card Learning Accuracy score) in children treated with CRT for brain tumors compared to a control group engaged in usual physical activity during the first 12 weeks.

ELIGIBILITY:

  • Children ages 8 - 18 years previously diagnosed with a brain tumor in childhood who are at least 1 year post-completion of CRT and who are not on an active anti-tumor treatment will be eligible.
  • Children should have reported or documented cognitive difficulties in attention, learning and memory, or processing speed per the child s parent or legal guardian.

DESIGN:

-This is a prospective single-institution trial. Children will be randomized to one of two groups: Group 1 (n=30): The immediate intervention group (the intervention group ) will participate in the enhanced PA home intervention group for the first 12 weeks; followed by 12 weeks of PA maintenance on their own.

Group 2 (n=30): The delayed intervention control group (the control group ) will engage in their usual physical activity (no intervention) for 12 weeks; followed by the enhanced PA home intervention for 12 weeks.

  • Neurobehavioral, circulating growth factors, and cardiorespiratory evaluations will be conducted at baseline (T0) and after the first 12 weeks at home (T2) in both the intervention and control groups. The acute effects of the in-lab PA will be assessed immediately following the baseline treadmill fitness test (T1) using selected cognitive measures in both groups. PA for both groups will be measured throughout the period at home via activity monitors.
  • After the completion of the first 12 week period at home and the follow-up evaluations (T2), the intervention group will be asked to maintain their PA levels on their own for the next 12 weeks while the control group will participate in the enhanced PA intervention at home for 12 weeks. A final cognitive evaluation will be conducted in both groups after the completion of the second 12- week period (T3). The primary outcome measure is the Cogstate One Card Learning Accuracy Score. The effects of PA on other neurobehavioral outcomes and circulating growth factors also will be examined.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Brain Tumor
Intervention  ICMJE Behavioral: Physical Activity
12 weeks of enhanced physical activity with Zamzee monitor.
Study Arms  ICMJE
  • Experimental: 1
    Enhanced PA home intervention group for the first 12weeks; followed by 12 weeks of PA maintenance ontheir own.
    Intervention: Behavioral: Physical Activity
  • Active Comparator: 2
    Usual physical activity (no intervention) for 12 weeks;followed by the enhanced PA home intervention for 12 weeks.
    Intervention: Behavioral: Physical Activity
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2014)
156
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.

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 to travel to NIH 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pamela L Wolters, Ph.D. (240) 760-6035 woltersp@mail.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02153957
Other Study ID Numbers  ICMJE 140116
14-C-0116
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pamela L Wolters, Ph.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date April 27, 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP