Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
NCT ID: NCT06799481
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-02-13
2027-07-31
Brief Summary
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Detailed Description
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I. Evaluate the feasibility of conducting a two-site pilot randomized controlled trial (RCT) to test the RISE in AYA brain tumor survivors.
II. Examine the impact of RISE on CRCI (primary) and physical activity (secondary).
EXPLORATORY OBJECTIVE:
I. Explore the impact of RISE on the gut microbiome diversity and composition.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (RISE INTERVENTION): Patients receive access to Physitrack and participate in personalized, progressive aerobic training over 30-40 minutes 3-5 days a week and strength training exercises 2 days a week for 12 weeks. Patients also receive active lifestyle behavior coaching over 10 minutes on 2 days a week for weeks 1-4 and then once weekly for weeks 5-12.
ARM II (ATTENTION CONTROL): Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12.
After completion of study intervention, patients are followed up at week 18.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Arm I (RISE)
Patients receive access to Physitrack and participate in personalized, progressive aerobic training over 30-40 minutes 3-5 days a week and strength training exercises 2 days a week for 12 weeks. Patients also receive active lifestyle behavior coaching over 10 minutes on 2 days a week for weeks 1-4 and then once weekly for weeks 5-12.
Aerobic Exercise
Participate in personalized, progressive aerobic training
Behavioral Intervention
Receive active lifestyle behavior coaching
Internet-Based Intervention
Receive access to Physitrack
Questionnaire Administration
Ancillary studies
Resistance Training
Participating in strength training exercises
Arm II (attention control)
Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12.
Follow-Up
Receive calls from the trainer
Medical Device Usage and Evaluation
Wear a Fitbit monitor
Questionnaire Administration
Ancillary studies
Interventions
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Aerobic Exercise
Participate in personalized, progressive aerobic training
Behavioral Intervention
Receive active lifestyle behavior coaching
Follow-Up
Receive calls from the trainer
Internet-Based Intervention
Receive access to Physitrack
Medical Device Usage and Evaluation
Wear a Fitbit monitor
Questionnaire Administration
Ancillary studies
Resistance Training
Participating in strength training exercises
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With primary brain tumor with cranial radiotherapy
* 6 months to 4 years post cranial radiotherapy
* Functional Assessment of Cancer Therapy (FACT)-Cognitive Function score \< 60 based on self-report (used among AYAs with non-neural cancer)
* Able to provide informed consent/assent
* Able to walk and receive clearance from a provider to participate based on the Physical Activity Readiness Questionnaire
* Currently engaging in \< 150 minutes of physical activity per week
* Willing to use smartphone-based applications (app)
Exclusion Criteria
* Moderate to severe traumatic brain injury with brain damage beyond that expected from brain tumor and treatment
* Developmental disorders (e.g., autism) or major psychotic illness (e.g., schizophrenia, depression) to avoid confounding impact related to these disorders
15 Years
39 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Emory University
OTHER
Responsible Party
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Jinbing Bai
Principal Investigator
Principal Investigators
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Jinbing Bai, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital
Atlanta, Georgia, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2025-00181
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00008229
Identifier Type: OTHER
Identifier Source: secondary_id
WINSHIP6364-24
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00008229
Identifier Type: -
Identifier Source: org_study_id
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