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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07359911
Status
Recruiting
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Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
12 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Exercise Intervention — BEHAVIORAL
    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.
  • Usual Care Control — BEHAVIORAL
    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.
  • Exit Interview — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 5, 2026
Status verified
Feb 2026
Primary completion
Aug 5, 2027
Completion
Aug 5, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Exercise Intervention Group (EXE)
    Participants in this group will undergo supervised multimodal (aerobic, resistance, balance) moderate-to-vigorous exercise intervention three 3 times per week for 12 weeks, a total of 36 sessions. Total participation duration is about 12 weeks.
  • Other: Usual Care Control Group (UC)
    Participants in this group may opt to receive a weekly brief symptom self-assessment as a survey. Total participation duration is about 12 weeks.

Primary Outcome Measure

Feasibility of Participant Engagement at Time of Consent [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Grey Freylersythe, BS
[email protected]
305-243-9832
Loren Yavelberg, PhD
[email protected]
Tracy E Crane, PhD, RDN (PRINCIPAL_INVESTIGATOR)
Gina D'Amato, MD (PRINCIPAL_INVESTIGATOR)
Jonathan Trent, MD (PRINCIPAL_INVESTIGATOR)
Sara St. George, PhD (PRINCIPAL_INVESTIGATOR)
Harleen Kaur, PhD (PRINCIPAL_INVESTIGATOR)
Loren Yavelberg, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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