NCT06957314招募中不适用
MATCHES-Novel: MAking Telehealth Delivery of Cancer Care at Home Effective and Safe for Novel Therapies: A Hospital-at-Home Model for Tarlatamab Delivery
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 14
- 主要终点
- Number of inpatient hospital days
研究概览
简要总结
The purpose of this study is to find out whether a Hospital-at-Home (HaH) program is a more efficient way to monitor people's health after receiving tarlatamab than monitoring in the hospital (inpatient).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of extensive stage small cell lung carcinoma (ES-SCLC)
- •Treatment plan of commercially available tarlatamab monotherapy as standard of care
- •Patients must be 18 years of age or older
- •Eastern Cooperative Oncology Group (ECOG) performance status <2
- •Patients must have adequate organ and bone marrow function, defined by the following laboratory results obtained within 28 days prior to the first study treatment:
- •ANC ≥ 1000 cells/μL (without granulocyte colony stimulating factor support within 4 weeks prior to Cycle 1, Day 1)
- •Platelet count ≥50,000/μL (without transfusion within 4 weeks prior to Cycle 1, Day 1)
- •Hemoglobin ≥8.0 g/dL (without transfusion within 4 weeks prior to Cycle 1, Day 1)
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 X upper limit of normal (ULN). Serum bilirubin ≤ 1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level ≤ 2 x ULN may be enrolled.
- •Estimated Glomerular Filtration Rate (eGFR) ≥ 30mL/min using the CKD-EPI formula.
- •The patient is willing to give and sign informed consent
- •Appropriate homebound setting as defined by one of the following:
- •Lodging at MSK Residence or hotel
- •5 New York City boroughs, lower Westchester County (northern boundary Cross County Parkway) and Nassau County (eastern boundary Wantagh State Parkway). This is based on the community paramedic (SeniorCare) 60-minute response time catchment area. If there is any uncertainty about patient residence eligibility, the Principal Investigator will decide after discussion with SeniorCare.
- •Patients must be accompanied by a caregiver for the period of time the patient is enrolled in the HaH intervention. For cases where there is uncertainty, the Principal Investigator will make the final determination.
- •Primary caregiver as identified by patient enrolled on study
- •Treating physician for patient(s) enrolled on study; managing treatment plan of commercially available tarlatamab as standard of care
排除标准
- •Patients with a documented active infection prior to starting tarlatamab. This includes grade 3 or higher viral, bacterial, or fungal infection.
- •Patients with baseline dementia or cognitive barriers
- •Uncontrolled arrhythmias
- •Caregiver deemed inappropriate by treating physician
- •No exclusion criteria
研究组 & 干预措施
Control Arm
No Intervention
Participants randomized to the control group will receive tarlatamab administration as per usual care.
Hospital-at-Home/HAH Intervention Arm
Experimental
Participants randomized to the intervention group will receive tarlatamab administration through the hospital-at-home care delivery model.
干预措施: Hospital-at-Home/HAH (Other)
结局指标
主要结局
Number of inpatient hospital days
时间窗: 14 days
Evaluate whether HaH in combination with an enhanced oncology specific telemedicine platform is efficient by quantifying inpatient hospital days during the two 7-day periods (14 days total) after the tarlatamab infusions scheduled for C1D1 and C1D8
次要结局
未报告次要终点
研究者
研究点 (14)
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