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| Name | Class |
|---|---|
| Florida Department of Health | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)). | Baseline, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grey Freylersythe, BS | Contact | 305-243-9832 | g.freylersythe@med.miami.edu | |
| Loren Yavelberg, PhD | Contact | l.yavelberg@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tracy E Crane, PhD, RDN | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 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. |
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| 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. |
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