Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients
ACTIVE-SARC
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2026
CompletedFirst Posted
Study publicly available on registry
January 22, 2026
CompletedStudy Start
First participant enrolled
February 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 5, 2027
February 18, 2026
February 1, 2026
1.5 years
January 14, 2026
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility of Participant Engagement at Time of Consent
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.
Baseline
Feasibility of Participant Engagement at All Time Points
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.
Up to 12 weeks
Acceptability of Participants that Feel Satisfied with Exercise Intervention
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.
12 weeks
Secondary Outcomes (1)
Change in Chemotherapy RDI (Relative Dose Intensity)
Baseline, 12 weeks
Study Arms (2)
Exercise Intervention Group (EXE)
EXPERIMENTALParticipants 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.
Usual Care Control Group (UC)
OTHERParticipants in this group may opt to receive a weekly brief symptom self-assessment as a survey. Total participation duration is about 12 weeks.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \< 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Florida Department of Healthcollaborator
- University of Miamilead
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tracy E Crane, PhD, RDN
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 14, 2026
First Posted
January 22, 2026
Study Start
February 5, 2026
Primary Completion (Estimated)
August 5, 2027
Study Completion (Estimated)
August 5, 2027
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share