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

Emory University60 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

Aerobic ExerciseOTHER

Participate in personalized, progressive aerobic training

Behavioral InterventionBEHAVIORAL

Receive active lifestyle behavior coaching

Follow-UpPROCEDURE

Receive calls from the trainer

Internet-Based InterventionOTHER

Receive access to Physitrack

Medical Device Usage and EvaluationOTHER

Wear a Fitbit monitor

Questionnaire AdministrationOTHER

Ancillary studies

Resistance TrainingOTHER

Participating in strength training exercises

Eligibility

Sex: ALLMin age: 15 YearsMax age: 39 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Enrollment

Feasibility will be ≥ 50% enrollment of eligible survivors. Descriptive statistics (e.g., frequency and percentage) will be used.

Time frame: Up to 1.5 years

Adherence to research intervention of virtually supervised exercise program (RISE)

Feasibility will be ≥ 75% adherence to RISE. Descriptive statistics (e.g., frequency and percentage) will be used.

Time frame: Up to 12 weeks

Retention

Feasibility will be ≥ 80% retention at end of intervention. Descriptive statistics (e.g., frequency and percentage) will be used.

Time frame: Up to 12 weeks

Acceptability

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.

Time frame: Up to 18 weeks

Change in physical activity levels

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.

Time frame: Baseline up to 18 weeks

Change in cancer-related cognitive impairment

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.

Time frame: Baseline up to 18 weeks

Secondary Outcomes

Gut microbiome

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.

Time frame: Up to 18 weeks

Physical function

Time frame: At baseline and at 12 and 18 weeks

Patient Quality of Life

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.