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| ID | Type | Description | Link |
|---|---|---|---|
| LCI-PED-NOS-EXER-001 | Other Identifier | Atrium |
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
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The purpose of this study is to see if there are physical and emotional benefits to participating in a structured exercise regimen for those who are ages 2-25, are newly diagnosed with a blood or solid tumor cancer, and are currently undergoing or will begin cancer treatment.
This is a randomized, controlled trial to investigate if a structured exercise regimen will have benefit relative to the control arm by increasing and /or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test and BOT-2 Brief or PDMS-2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXER | Experimental | "Just Move" exercises |
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| SOC EXER | Experimental | Standard of Care Exercise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Just Move" Exercise | Other | Subjects complete "Just Move" Exercises Five Times Per Week |
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| Measure | Description | Time Frame |
|---|---|---|
| Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment | Investigate if 30 minutes of exercise, five days per week, will have benefit relative to the control arm by increasing and/or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test | 18 month period |
| Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment | Investigate if 30 minutes of exercise, five days per week, will have benefit relative to the control arm by increasing and/or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by BOT-2 Brief (in subjects ≥ 4 years of age) or PDMS-2 (in subjects < 4 years of age). | 18 month period |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Rate | Occurrence of Adverse Events of Special Interest (thromboembolic event, skin ulceration, significant nausea/vomiting, and constipation) will be measured as binary variables. | up to 18 months |
| Quality of Life measured by the PedsQL Cancer Module |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meg Lattanze | Contact | (980) 442-4239 | Megan.Lattanze@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Pope, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Children's Hospital | Recruiting | Charlotte | North Carolina | 28203 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Standard of Care Exercise |
| Other |
Subjects exercise/move as tolerated |
|
Investigate if a structured exercise regimen relative to the control arm will result in Increasing and /or maintaining quality of life as measured by the PedsQL Cancer Module. Peds QL scores will be calculated as a composite quantitative analogue variable ranging from zero (best score) to 100 (worst score). |
| up to 18 months |
| Subject adherence to exercise regimen | Subject adherence to exercise regimen will be determined by patient-reported tracker listing activity performed and duration of time of activity. Data collected will be normalized quantitatively based on intended activity. | up to 18 months |
| Adverse Events Related to Exercise Program | To summarize adverse event rates deemed to be related to the protocol directed exercise program. Adverse events of special interest (Grade 2 or greater Bone fracture, Fall, and Muscle aches/Myalgia) will be captured for each subject and time point randomized to the intervention arm. | up to 18 months |