NCT07359911 · University of Miami
Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients
(ACTIVE-SARC)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Exercise Intervention
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.
BEHAVIORAL
Usual Care Control
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.
BEHAVIORAL
Exit Interview
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.
Primary outcome measures
Feasibility of Participant Engagement at Time of Consent
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.
Feasibility of Participant Engagement at All Time Points
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.
Acceptability of Participants that Feel Satisfied with Exercise Intervention
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of Sarcoma
- Pediatric or AYA (12-39 years old)
- Able to provide written informed consent
- Able to speak, read, and understand English or Spanish
- Initiating first-line systemic therapy (Doxorubicin, Ifosfamide, Gemcitabine, Docetaxel, Trabectedin, Vincristine, Irinotecan, Temozolomide, Topotecan, Etoposide, Dacarbazine, Pazopanib, Tazemetostat, Imatinib, Sunitinib, Pembrolizumab, Nivolumab, Ipilumumab, Regorafenib, Atezulimumab). Participants can be enrolled up to 90 days after starting firstline systemic therapy.
- Approval from a medical oncology provider to participate.
- Having not consistently (not equal to or more than 50% of the time) engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months
- Having not consistently engaged in resistance training 2 or more days per week over the past 3 months
Exclusion criteria
- \< 12 or \>39 years old
- Unable to provide consent
- Unable to read or understand English or Spanish
- Oxygen-dependent
- Unable to walk 2 blocks without assistance (excluding canes)
- Unstable bone metastases
- More than 90 days from initiation of first-line systemic therapy.
- Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention, as determined by the patient's provider and study clinician.
Where
- Miami, Florida
Collaborators
Florida Department of Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations