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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-00181 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00008229 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| WINSHIP6364-24 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Other | Participate in personalized, progressive aerobic training |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinbing Bai, PhD, RN | Contact | 404-727-2466 | jinbing.bai@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jinbing Bai, PhD, RN | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
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To maintain blinding, only the exercise trainer and statistician will know group assignments.
| Behavioral Intervention | Behavioral | Receive active lifestyle behavior coaching |
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| Follow-Up | Procedure | Receive calls from the trainer |
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| Internet-Based Intervention | Other | Receive access to Physitrack |
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| Medical Device Usage and Evaluation | Other | Wear a Fitbit monitor |
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| Questionnaire Administration | Other | Ancillary studies |
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| Resistance Training | Other | Participating in strength training exercises |
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| Baseline up to 18 weeks |
| Up to 18 weeks |
| Physical function | 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. | 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. | At baseline and at 12 and 18 weeks |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D001521 | Behavior Therapy |
| D000081204 | Chromatin Immunoprecipitation Sequencing |
| D005500 | Follow-Up Studies |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D047369 | Chromatin Immunoprecipitation |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D059014 | High-Throughput Nucleotide Sequencing |
| D017421 | Sequence Analysis |
| D017422 | Sequence Analysis, DNA |
| D047468 | Immunoprecipitation |
| D007158 | Immunologic Techniques |
| D015331 | Cohort Studies |
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
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