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The goal of this clinical trial is to explore the impact that an at-home cardio-oncology rehabilitation (CORE) may have on short-term cardiovascular fitness and psychosocial wellness in pediatric cancer survivors. The main question it aims to answer are
Participants will undergo cardiovascular studies and a quality-of-life survey prior to exercise intervention, and at the end of the 6-month study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardio-oncology rehabilitation | Behavioral | Least 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiovascular fitness after completion of a 6-month exercise intervention. | Peak VO2% (exercise capacity) as measured by cardiopulmonary exercise testing. | Baseline to 6 months |
| Change in cardiovascular fitness after completion of a 6-month exercise intervention. | Ve/VCO2 slope (predictor of cardiac mortality) as measured by cardiopulmonary exercise testing. | Baseline to 6 months |
| Change in cardiovascular fitness after completion of a 6-month exercise intervention. | Chronotropic response (heart rate response to exercise) as measured by cardiopulmonary exercise testing. | Baseline to 6 months |
| Change in cardiovascular fitness after completion of a 6-month exercise intervention. | Blood pressure response to exercise as measured by cardiopulmonary exercise testing. | Baseline to 6 months |
| Change in cardiac function after completion of a 6-month exercise intervention. | Cardiac function will be assessed via echocardiogram. | Baseline to 6 months |
| Change in cardiac rhythm after completion of a 6-month exercise intervention. | Cardiac rhythm will be assessed via EKG. | Baseline to 6 months |
| Change in cardiac stress after completion of a 6-month exercise intervention. | Cardiac stress will be assessed via NT-proBNP level. |
| Measure | Description | Time Frame |
|---|---|---|
| Average change in reported quality of life from baseline to 6 months | PedsQL(TM) Measurement Model will be used, which assesses physical, emotional, social, school functioning domains. | Baseline to 6 months |
| Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Obdulio Carreras | Contact | (323) 361-4663 | ocarreras@chla.usc.edu | |
| Jennifer Su, MD | Contact | (323) 361-5136 | jsu@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Su, MD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Baseline to 6 months |
| Average change in triglyceride level as measured from baseline to 6 months. | Triglyceride (mg/dL) will be measured. | Baseline to 6 months |
| Average change in total cholesterol level as measured from baseline to 6 months. | Total cholesterol (mg/dL) will be measured. | Baseline to 6 months |
| Average change in high density lipoprotein level as measured from baseline to 6 months. | High density lipoprotein (HDL) (mg/dL) will be measured. | Baseline to 6 months |
| Average change in low density lipoprotein as measured from baseline to 6 months. | Low density lipoprotein (LDL) (mg/dL) will be measured. | Baseline to 6 months |
| Average change in very low density lipoprotein as measured from baseline to 6 months. | Very low density lipoprotein (VLDL) (mg/dL) will be measured. | Baseline to 6 months |
Lifestyle habits will be assessed via exercise and dietary surveys completed by each participant. |
| Baseline to 6 months |
| Average change in activity level from baseline to 6 months | Activity levels will be assessed via exercise surveys as well as continuous FitBit(TM) activity data which will include weekly number of steps, average calorie burn, days of exercise, minute in activity, and average sleep time. | Baseline to 6 months |