RECRUITING

Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Virtually Delivered Home-Based Exercise Intervention on Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors: A Pilot Randomized Controlled Trial

Quick Facts

Study Start:2025-02-13

Study Completion:2027-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06799481

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 39 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Jinbing Bai, PhD, RN

CONTACT

404-727-2466

jinbing.bai@emory.edu

Principal Investigator

Jinbing Bai, PhD, RN

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University Hospital

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Jinbing Bai, PhD, RN, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-13

Study Completion Date2027-07-31

Study Record Updates

Study Start Date2025-02-13

Study Completion Date2027-07-31

Terms related to this study

Additional Relevant MeSH Terms

Cancer-related Cognitive Dysfunction
Primary Brain Neoplasm