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

Emory University

Status

Enrolling

Conditions

Cancer-related Cognitive Dysfunction

Primary Brain Neoplasm

Treatments

Other: Aerobic Exercise

Behavioral: Behavioral Intervention

Procedure: Follow-Up

Other: Internet-Based Intervention

Other: Resistance Training

Other: Questionnaire Administration

Other: Medical Device Usage and Evaluation

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06799481

P30CA138292 (U.S. NIH Grant/Contract)

NCI-2025-00181 (Registry Identifier)

STUDY00008229 (Other Identifier)

WINSHIP6364-24 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

15 to 39 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Arm I (RISE)

Experimental group

Description:

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.

Treatment: