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RECRUITINGINTERVENTIONAL

Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients

Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients (ACTIVE-SARC)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Diagnosis of Sarcoma 2. Pediatric or AYA (12-39 years old) 3. Able to provide written willing to sign a consent form 4. Able to speak, read, and understand English or Spanish 5. 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. 6. Approval from a medical oncology provider to participate. 7. 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 8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months Who Should NOT Join This Trial: 1. \< 12 or \>39 years old 2. Unable to provide consent 3. Unable to read or understand English or Spanish 4. Oxygen-dependent 5. Unable to walk 2 blocks without assistance (excluding canes) 6. Unstable bone metastases 7. More than 90 days from initiation of first-line systemic therapy. 8. 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Diagnosis of Sarcoma 2. Pediatric or AYA (12-39 years old) 3. Able to provide written informed consent 4. Able to speak, read, and understand English or Spanish 5. 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. 6. Approval from a medical oncology provider to participate. 7. 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 8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months Exclusion Criteria: 1. \< 12 or \>39 years old 2. Unable to provide consent 3. Unable to read or understand English or Spanish 4. Oxygen-dependent 5. Unable to walk 2 blocks without assistance (excluding canes) 6. Unstable bone metastases 7. More than 90 days from initiation of first-line systemic therapy. 8. 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.

Treatments Being Tested

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.

Locations (1)

University of Miami
Miami, Florida, United States