RecruitingNot ApplicableNCT07359911

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)


Sponsor

University of Miami

Enrollment

40 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 12 YearsMax Age: 39 Years

Inclusion Criteria8

  • 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 Criteria8

  • < 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.

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Interventions

BEHAVIORALExercise 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.

BEHAVIORALUsual 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.

BEHAVIORALExit 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

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NCT07359911


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