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

NCT06799481 | Recruiting

• 4 other identifiers: STUDY00008229NCI-2025-00181WINSHIP6364-24P30CA138292
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer-related Cognitive Dysfunction; Primary Brain Neoplasm

Outcome Measures

Primary Outcomes (6)

• Enrollment

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

  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.

  Up to 12 weeks

• Retention

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

  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.

  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.

  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.

  Baseline up to 18 weeks

Secondary Outcomes (3)

• Gut microbiome

  Up to 18 weeks

• Physical function

  At baseline and at 12 and 18 weeks

• Patient Quality of Life

  At baseline and at 12 and 18 weeks

Study Arms (2)

Arm I (RISE)

EXPERIMENTAL

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.

Other: Aerobic Exercise; Behavioral: Behavioral Intervention; Other: Internet-Based Intervention; Other: Questionnaire Administration; Other: Resistance Training

Arm II (attention control)

ACTIVE COMPARATOR

Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12.

Procedure: Follow-Up; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration

Interventions

Aerobic Exercise OTHER

Participate in personalized, progressive aerobic training

Also known as: Aerobic Activity

Arm I (RISE)

Behavioral Intervention BEHAVIORAL

Receive active lifestyle behavior coaching

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Arm I (RISE)

Follow-Up PROCEDURE

Receive calls from the trainer

Also known as: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up, follow_up, Followed, Followup

Arm II (attention control)

Internet-Based Intervention OTHER

Receive access to Physitrack

Arm I (RISE)

Medical Device Usage and Evaluation OTHER

Wear a Fitbit monitor

Arm II (attention control)

Questionnaire Administration OTHER

Ancillary studies

Arm I (RISE); Arm II (attention control)

Resistance Training OTHER

Participating in strength training exercises

Also known as: Strength Training

Arm I (RISE)

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 15-39 years
• With primary brain tumor with cranial radiotherapy
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Exercise; Behavior Therapy; Chromatin Immunoprecipitation Sequencing; Follow-Up Studies; Resistance Training

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Psychotherapy; Behavioral Disciplines and Activities; Chromatin Immunoprecipitation; Genetic Techniques; Investigative Techniques; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, DNA; Immunoprecipitation; Immunologic Techniques; Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Jinbing Bai, PhD, RN

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinbing Bai, PhD, RN

CONTACT

404-727-2466; jinbing.bai@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: To maintain blinding, only the exercise trainer and statistician will know group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: February 13, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

US (2)