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

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

Overview

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.

Interventions

• Other Aerobic Exercise
  Participate in personalized, progressive aerobic training
• Behavioral Behavioral Intervention
  Receive active lifestyle behavior coaching
• Procedure Follow-Up
  Receive calls from the trainer
• Other Internet-Based Intervention
  Receive access to Physitrack
• Other Medical Device Usage and Evaluation
  Wear a Fitbit monitor
• Other Questionnaire Administration
  Ancillary studies
• Other Resistance Training
  Participating in strength training exercises

Primary outcome measures

• Enrollment [Time frame: Up to 1.5 years]
• Adherence to research intervention of virtually supervised exercise program (RISE) [Time frame: Up to 12 weeks]
• Retention [Time frame: Up to 12 weeks]
• Acceptability [Time frame: Up to 18 weeks]
• Change in physical activity levels [Time frame: Baseline up to 18 weeks]
• Change in cancer-related cognitive impairment [Time frame: Baseline up to 18 weeks]

Secondary outcome measures (3)

• Gut microbiome [Time frame: Up to 18 weeks]
• Physical function [Time frame: At baseline and at 12 and 18 weeks]
• Patient Quality of Life [Time frame: At baseline and at 12 and 18 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Emory University Hospital — Atlanta
• MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06799481 · STUDY00008229 · NCI-2025-00181 · STUDY00008229 · WINSHIP6364-24 · P30CA138292

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗