Sarcoma
Conditions
Keywords
Pediatric, Adolescent, Young Adult
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.
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.
Sponsors
University of Miami
Florida Department of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 39 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Participant Engagement at Time of Consent | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Chemotherapy RDI (Relative Dose Intensity) | Baseline, 12 weeks | 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)). |
Countries
United States
Contacts
CONTACTGrey Freylersythe, BS
CONTACTLoren Yavelberg, PhD
PRINCIPAL_INVESTIGATORTracy E Crane, PhD, RDN
University of Miami
Outcome results
None listed