NCT06799481 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Cancer-related Cognitive Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-13 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-02-13 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial evaluates the impact of a research intervention of virtually supervised exercise program (RISE) on cancer-related cognitive impairment (CRCI), physical activity in adolescent and young adult (AYA) brain tumor survivors. This clinical trial also evaluates the impact of RISE on the collection of microorganisms that exist in the intestines (gut microbiome). Up to 45% of AYA brain tumor survivors experience CRCI, including issues with attention and memory. CRCI can have a negative impact on education, independent living and can worsen long-term quality of life. Moderate-intensity levels of exercise, particularly aerobic and resistance training, have been shown to improve cognitive function. Additionally, exercise can change the composition and function of the gut microbiome, which may lead to improved cognitive function. Unfortunately, only about 50% of AYAs with cancer receive exercise information or meet the physical activity recommendations. Tailoring a virtually delivered exercise intervention to meet the unique needs of AYAs may improve access to exercise. Participating in the virtual home-based exercise intervention, RISE, may improve physical activity and cognitive impairment in AYA brain tumor survivors and may also help researchers understand the relationship of exercise on the gut microbiome and cognitive function.
Eligibility Criteria
Inclusion Criteria: * Age 15-39 years * 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: * Secondary malignancies, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain * 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
Contact & Investigator
Jinbing Bai, PhD, RN
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT06799481 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 39 Years, studying Cancer-related Cognitive Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06799481 currently recruiting?
Yes, NCT06799481 is actively recruiting participants. Contact the research team at jinbing.bai@emory.edu for enrollment information.
Where is the NCT06799481 trial being conducted?
This trial is being conducted at Atlanta, United States, Houston, United States.
Who is sponsoring the NCT06799481 clinical trial?
NCT06799481 is sponsored by Emory University. The principal investigator is Jinbing Bai, PhD, RN at Emory University. The trial plans to enroll 60 participants.
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