A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of AYA Cancer

Study Overview
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Brief Summary
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The main goal of this clinical trial is to use a novel exercise intervention to improve cardiometabolic and biopsychosocial health outcomes in overweight/obese sedentary survivors of AYA cancers at risk for chronic comorbid conditions. The investigator's hypothesis is that an exercise intervention will improve: cardiometabolic health; body composition; physical fitness and biopsychosocial outcomes when compared to the attention control group.

Official Title
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A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of Adolescent and Young Adult Cancer: The ACSEND Trial

Conditions
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Cardiometabolic Dysregulation, Young Adult Cancer, Adolescent Cancer, Body Composition

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AYA cancer survivors (18-39) Must be 12 months after treatment No metastatic disease Exclusion Criteria: Metastatic disease Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise<br>Will receive the exercise intervention | Other: Exercise<br>* personalized exercise prescription<br>|
| No Intervention: Attention Control<br>Will not receive the exercise intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiometabolic health - Insulin Resistance | insulin resistance estimated by HOMA from a fasting blood sample | change from baseline to 4 months, to 8 months to 1 year | 
| Cardiometabolic health - metabolic syndrome waist circumference | markers of metabolic syndrome, waist circumference via measuring tape (cm) | change from baseline to 4 months, to 8 months to 1 year | 
| Cardiometabolic health - metabolic syndrome blood pressure | markers of metabolic syndrome, blood pressure via Omron cuff (mmHg) | change from baseline to 4 months, to 8 months to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | fat mass and lean mass via DEXA (reported in lbs) | change from baseline to 4 months, to 8 months to 1 year | 
| Cardiorespiratory fitness (Physical Fitness) | cardiorespiratory fitness via submaximal VO2 max (reported via ml/kg/min) | change from baseline to 4 months, to 8 months to 1 year | 
| Muscular Strength (Physical Fitness) | muscle strength through multiple repetition maximum (lbs) | change from baseline to 4 months, to 8 months to 1 year |