Cancer-related Cognitive DysfunctionNCT06799481
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
A study testing Aerobic Exercise, Behavioral Intervention and Follow-Up in people with Cancer-related Cognitive Dysfunction and Primary Brain Neoplasm, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
- What is being tested?
- Aerobic Exercise, Behavioral Intervention and Follow-Up
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Feb 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Emily Bush, BS, emily.bush@emoryhealthcare.org
Jinbing Bai, PhD, RN
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Keri Schadler, PhD, 713-794-1035, klschadl@mdanderson.org
Maria Chang Swartz, mchang1@mdanderson.org
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Aerobic Exercise, Behavioral Intervention, Follow-Up, Internet-Based Intervention, Medical Device Usage and Evaluation
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Also called Aerobic Activity
Participate in personalized, progressive aerobic training
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Receive active lifestyle behavior coaching
Follow-UpProcedure or surgery
Also called Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up
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
Also called Strength Training
Participating in strength training exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Follow-Up; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Feasibility will be ≥ 50% enrollment of eligible survivors. Descriptive statistics (e.g., frequency and percentage) will be used.
Measured: 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.
Measured: Up to 12 weeks
Retention
Feasibility will be ≥ 80% retention at end of intervention. Descriptive statistics (e.g., frequency and percentage) will be used.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 18 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At baseline and at 12 and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start13 Feb 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Responsible party
- Principal investigator, Jinbing Bai, Emory University
- Investigators
- Jinbing Bai, PhD, RN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799481
- Sponsor's protocol ID
- STUDY00008229
- Other IDs
- NCI-2025-00181, STUDY00008229, WINSHIP6364-24, P30CA138292
- Status last verified
- Nov 2026
- First submitted
- 23 Jan 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06799481
- Acronym / sponsor ID
- STUDY00008229
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (RISE) | Experimental | Other: Aerobic Exercise, Behavioral: Behavioral Intervention, Other: Internet-Based Intervention, Other: Questionnaire Administration, Other: Resistance TrainingPatients 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) | Active comparator | Procedure: Follow-Up, Other: Medical Device Usage and Evaluation, Other: Questionnaire AdministrationPatients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12. |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAlso: Aerobic ActivityParticipate in personalized, progressive aerobic training | Other | Arm I (RISE) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyReceive active lifestyle behavior coaching | Behavioural | Arm I (RISE) |
| Follow-UpAlso: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow UpReceive calls from the trainer | Procedure or surgery | Arm II (attention control) |
| Internet-Based InterventionReceive access to Physitrack | Other | Arm I (RISE) |
| Medical Device Usage and EvaluationWear a Fitbit monitor | Other | Arm II (attention control) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (RISE), Arm II (attention control) |
| Resistance TrainingAlso: Strength TrainingParticipating in strength training exercises | Other | Arm I (RISE) |
Primary outcome
Enrollment
Time frame: Up to 1.5 years
Feasibility will be ≥ 50% enrollment of eligible survivors. Descriptive statistics (e.g., frequency and percentage) will be used.
Adherence to research intervention of virtually supervised exercise program (RISE)
Time frame: Up to 12 weeks
Feasibility will be ≥ 75% adherence to RISE. Descriptive statistics (e.g., frequency and percentage) will be used.
Retention
Time frame: Up to 12 weeks
Feasibility will be ≥ 80% retention at end of intervention. Descriptive statistics (e.g., frequency and percentage) will be used.
Acceptability
Time frame: Up to 18 weeks
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.
Change in physical activity levels
Time frame: Baseline up to 18 weeks
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.
Change in cancer-related cognitive impairment
Time frame: Baseline up to 18 weeks
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinbing Bai, PhD, RN principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, Behavioral Intervention and Follow-Up in people with Cancer-related Cognitive Dysfunction and Primary Brain Neoplasm, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinbing Bai, PhD, RN (404-727-2466, jinbing.bai@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: Up to 1.5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.