Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients (ACTIVE-SARC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of Participant Engagement at Time of Consent
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •< 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.
研究组 & 干预措施
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.
干预措施: Exercise Intervention (Behavioral)
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.
干预措施: Exit Interview (Behavioral)
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.
干预措施: Usual Care Control (Behavioral)
结局指标
主要结局
Feasibility of Participant Engagement at Time of Consent
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Chemotherapy RDI (Relative Dose Intensity)(Baseline, 12 weeks)
研究者
Tracy E Crane, PhD, RDN
Associate Professor
University of Miami