University of Miami
Miami, Florida, 33136, United States
Location status: Recruiting
NCT Number: NCT07359911
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.
Interested in participating?
Request Info12 year–39 year
All sexes
Interventional
Not applicable
Miami, Florida, 33136, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline
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: Up to 12 weeks
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: 12 weeks
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: Baseline, 12 weeks
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)).
Interested in participating?
Request InfoUniversity of Miami
Other
Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients (ACTIVE-SARC)
Acronym: ACTIVE-SARC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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