Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
Conditions
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.
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
OTHERAerobic Exercise
Participate in personalized, progressive aerobic training
BEHAVIORALBehavioral Intervention
Receive active lifestyle behavior coaching
PROCEDUREFollow-Up
Receive calls from the trainer
OTHERInternet-Based Intervention
Receive access to Physitrack
OTHERMedical Device Usage and Evaluation
Wear a Fitbit monitor
OTHERQuestionnaire Administration
Ancillary studies
OTHERResistance Training
Participating in strength training exercises
Sponsors
National Cancer Institute (NCI)
NRG Oncology
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
To maintain blinding, only the exercise trainer and statistician will know group assignments.
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cancer-related cognitive impairment | 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. |
| Retention | Up to 12 weeks | Feasibility will be ≥ 80% retention at end of intervention. Descriptive statistics (e.g., frequency and percentage) will be used. |
| Acceptability | 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 | 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. |
| Enrollment | 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) | Up to 12 weeks | Feasibility will be ≥ 75% adherence to RISE. Descriptive statistics (e.g., frequency and percentage) will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical function | At baseline and at 12 and 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. |
| Patient Quality of Life | At baseline and at 12 and 18 weeks | 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. |
| Gut microbiome | Up to 18 weeks | 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. |
Countries
United States
Contacts
Primary ContactJinbing Bai, PhD, RN
Outcome results
None listed