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

Not Applicable

Recruiting

• Conditions: Cancer-related Cognitive Dysfunction; Primary Brain Neoplasm

• Registration Number: NCT06799481
• Lead Sponsor: Emory University

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.

Detailed Description

PRIMARY OBJECTIVES:

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.

Study Timeline

• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Study Start: 2025-02-13
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Enrollment	Up to 1.5 years	Feasibility will be ≥ 50% enrollment of eligible survivors. Descriptive statistics (e.g., frequency and percentage) will be used.
Adherence to research intervention of virtually supervised exercise program (RISE)	Up to 12 weeks	Feasibility will be ≥ 75% adherence to RISE. Descriptive statistics (e.g., frequency and percentage) will be used.
Retention	Up to 12 weeks	Feasibility will be ≥ 80% retention at end of intervention. Descriptive statistics (e.g., frequency and percentage) will be used.
Change in cancer-related cognitive impairment	Baseline up to 18 weeks	Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.
Acceptability	Up to 18 weeks	Will use an 11-item acceptability questionnaire. A ≥ 4 ("agree" to "strongly agree") per item equates to acceptability. Descriptive statistics (e.g., frequency and percentage) will be used.
Change in physical activity levels	Baseline up to 18 weeks	Will be measured by Fitbit. Physical activity estimates considered as valid if the monitor is worn ≥ 10 hours/day on ≥ 4 days. Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.

Secondary Outcome Measures

Name	Time	Method
Physical function	At baseline and at 12 and 18 weeks	Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.
Gut microbiome	Up to 18 weeks	Fecal specimens will be collected for the gut microbiome. Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.
Patient Quality of Life	At baseline and at 12 and 18 weeks	Will be assessed by Patient Reported Outcomes Measurement Information System-29 recommended. Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States