SarcomaACTIVE-SARCNCT07359911
Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients
A study testing Exercise Intervention and Exit Interview in people with Sarcoma, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 39 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- Exercise Intervention and Exit Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 5 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- < 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Loren Yavelberg, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Grey Freylersythe, BS, 305-243-9832, g.freylersythe@med.miami.edu
Loren Yavelberg, PhD, l.yavelberg@med.miami.edu
About this study
Official title: Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients (ACTIVE-SARC)
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.
- Conditions
- Sarcoma
- Being tested
- Exercise Intervention, Usual Care Control, Exit Interview
- Keywords
- Pediatric, Adolescent, Young Adult
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
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 ControlBehavioural
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 InterviewBehavioural
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 group | Role | What they receive |
|---|---|---|
| Exercise Intervention Group (EXE) | Experimental | 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. Receives: Behavioral: Exercise Intervention; Behavioral: Exit Interview |
| Usual Care Control Group (UC) | Other | Participants in this group may opt to receive a weekly brief symptom self-assessment as a survey.
Total participation duration is about 12 weeks. Receives: Behavioral: Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (1)
Change in Chemotherapy RDI (Relative Dose Intensity)
Change in chemotherapy relative dose intensity (RDI) at 12 weeks compared to baseline will be reported between both the intervention and control arms. RDI is the ratio of actual dose intensity to projected dose intensity, as a percentage or proportion of the amount of drug planned to deliver per weeks (mg/(m^2 x week)).
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start5 Feb 2026
- Primary completion5 Aug 2027 (estimated)
- Study completion5 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Principal investigator, Tracy E Crane, PhD, RDN, University of Miami
- Investigators
- Tracy E Crane, PhD, RDN, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359911
- Sponsor's protocol ID
- 20250858
- Acronym
- ACTIVE-SARC
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients (ACTIVE-SARC)
- ClinicalTrials.gov ID
- NCT07359911
- Acronym / sponsor ID
- ACTIVE-SARC / 20250858
- Conditions
- Sarcoma
- Keywords
- Pediatric, Adolescent, Young Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 5 Aug 2027 (estimated)
- Study completion
- 5 Aug 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention Group (EXE) | Experimental | Behavioral: Exercise Intervention, Behavioral: Exit InterviewParticipants 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) | Other | Behavioral: Usual Care ControlParticipants in this group may opt to receive a weekly brief symptom self-assessment as a survey. Total participation duration is about 12 weeks. |
Who may qualify
- Ages
- 12 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- < 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionEach 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. | Behavioural | Exercise Intervention Group (EXE) |
| Usual Care ControlA 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. | Behavioural | Usual Care Control Group (UC) |
| Exit InterviewA 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. | Behavioural | Exercise Intervention Group (EXE) |
Primary outcome
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.
1 secondary outcome
Change in Chemotherapy RDI (Relative Dose Intensity)
Time frame: Baseline, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Loren Yavelberg, PhD contact
Tracy E Crane, PhD, RDN principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention and Exit Interview in people with Sarcoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grey Freylersythe, BS (305-243-9832, g.freylersythe@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Participant Engagement at Time of Consent (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.