This clinical trial tests whether Hospital-at-Home (HaH) is more efficient than inpatient hospital stays for monitoring patients with extensive-stage small cell lung cancer (ES-SCLC) who are receiving tarlatamab as part of their usual care. Patients receiving tarlatamab are usually hospitalized for at least 24 hours after each dose. HaH or short-term care delivery within patients’ homes, is an emerging health care delivery innovation. HaH makes it possible to check on patient's health at home instead of staying in the hospital. The HaH model has shown reductions in hospitalizations, hospital length of stay, emergency department (ED) use, and cost of care. HaH may be a more efficient way to monitor patients with ES-SCLC receiving tarlatamab.
Additional locations may be listed on ClinicalTrials.gov for NCT06957314.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Robert Michael Daly
Phone: 646-608-3789
PRIMARY OBJECTIVE:
I. 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 cycle 1 day 1 (C1D1) and C1 day 8 (C1D8).
SECONDARY OBJECTIVES:
I. Evaluate whether HaH in combination with an enhanced oncology specific telemedicine platform is safe for patients with ES-SCLC receiving tarlatamab by quantifying "patient escalations" as defined by Centers for Medicare and Medicaid as the number of patients whose care involved a transfer to a traditional inpatient setting from the home for further care1, emergency department and urgent care visits without admission, and clinician-adjudicated toxicity (Common Terminology Criteria for Adverse Events [CTCAE]) as well as the American Society for Transplantation and Cellular Therapy (ASTCT) grading scales for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
II. Patient and caregiver experiences and preferences: patient and caregiver interviews and surveys including preference for HaH versus inpatient monitoring.
III. Physician experiences and preferences: physician interviews and surveys including preference for HaH versus inpatient monitoring.
IIIa. Evaluating which aspects of HaH intervention are necessary versus (vs) redundant, including the community paramedic, telehealth visit, and home labs.
EXPLORATORY OBJECTIVES:
I. Explore which patients are declining participation in the study and reasons why they declined. (Equity)
Ia. Explore the proportion of patients requiring loaner hardware and/or web plan supports to participate in this study. (Equity)
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive standard of care (SOC) tarlatamab intravenously (IV) over 1 hour on days 1 and 8 of cycle 1 and undergo inpatient monitoring for 22-24 hours after each infusion.
GROUP II: Patients receive SOC tarlatamab IV over 1 hour on days 1 and 8 of cycle 1 and undergo inpatient monitoring for 22-24 hours after each infusion. Within 3 hours discharge, patients receive community paramedic visit on days 1, 2, 8 and 9 of cycle 1 and receive a telemedicine visit with provider on days 2 and 9.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorRobert Michael Daly
