The purpose of this study is to determine the effects of a multimodal exercise intervention on chemotherapy uptake in newly diagnosed pediatric, adolescent and young adult (AYA) Sarcoma patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Each session will include a brief conversation and standardized symptom assessment, followed by a warm-up including stretching \& balance exercises, then a series of resistance exercises, ending with light-moderate intensity aerobic exercise (walking), with a target goal of 45-60 minutes total per session as tolerated by the patient.
A weekly brief symptom self-assessment as a survey will be delivered by Redcap survey, in person or remotely, or by telephone with researcher assistance. Completion of the survey will take approximately 10 minutes per week.
A semi-structured interview will be administered at 12 weeks to the intervention (EXE) group only to explore self-determination and efficacy, as well as intervention acceptability.
University of Miami
Miami, Florida, United States
Feasibility of Participant Engagement at Time of Consent
Feasibility will be measured as the percentage of participants that consent and meet eligibility to participate between both the intervention and control arms. Criterion for success: At least (≥) 50% of all eligible participants consent to participate between both arms.
Time frame: Baseline
Feasibility of Participant Engagement at All Time Points
Feasibility will be measured as the percentage of participants that adhere to and complete the arm-specific intervention and data collection at all time points between both the intervention and control arms. Criterion for success: Greater than (\>) 70% of all eligible participants between both arms complete all scheduled assessments.
Time frame: Up to 12 weeks
Acceptability of Participants that Feel Satisfied with Exercise Intervention
Acceptability will be measured as the percentage of participants that report satisfaction with the exercise intervention. Criterion for success: Greater than (\>) 80% of all eligible participants complete the exercise intervention.
Time frame: 12 weeks
Change in Chemotherapy RDI (Relative Dose Intensity)
Change in chemotherapy relative dose intensity (RDI) at 12 weeks compared to baseline will be reported between both the intervention and control arms. RDI is the ratio of actual dose intensity to projected dose intensity, as a percentage or proportion of the amount of drug planned to deliver per weeks (mg/(m\^2 x week)).
Time frame: Baseline, 12 weeks
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