This study aims to develop and evaluate a multidisciplinary team (MDT)-based nursing intervention system for patients with advanced small cell lung cancer (SCLC) receiving chemo-immunotherapy.

In this single-center, prospective, randomized controlled trial, 200 patients with stage IIIb-IV SCLC are randomly assigned to either an MDT-based nursing intervention group or a routine care group. All patients receive standard first-line platinum-based chemotherapy combined with immune checkpoint inhibitors. The MDT intervention includes structured adverse event monitoring, early warning and rapid response for immune-related adverse events, adherence management, nutritional and exercise support, and psychological care.

The primary outcome is the incidence of grade ≥3 treatment-related adverse events. Secondary outcomes include treatment adherence (MMAS-8), completion rate of planned treatment cycles, quality of life (EORTC QLQ-C30), and tumor response (RECIST 1.1).

The study evaluates whether MDT-based nursing can improve safety, treatment adherence, quality of life, and short-term clinical outcomes compared with routine nursing care.

This study is a single-center, prospective, randomized controlled trial designed to evaluate the effectiveness of a multidisciplinary team (MDT)-based nursing intervention system in patients with advanced small cell lung cancer (SCLC) undergoing chemo-immunotherapy.

A total of 200 patients with stage IIIb-IV SCLC were enrolled and randomly assigned in a 1:1 ratio to either an MDT nursing intervention group or a routine care group. All patients received standard first-line platinum-based chemotherapy combined with etoposide and PD-1/PD-L1 immune checkpoint inhibitors. Treatment was administered in 3-week cycles for four cycles, followed by maintenance immunotherapy when appropriate.

The MDT-based nursing intervention system was developed using the Delphi method and consists of a structured framework including multidisciplinary coordination, adverse event monitoring, adherence management, and supportive care. The MDT team includes oncology nurses, oncologists, a clinical pharmacist, a nutritionist, and a psychologist. The intervention includes daily joint rounds, weekly MDT meetings, early identification and graded management of immune-related adverse events, standardized follow-up within 48-72 hours after treatment, and predefined early warning criteria for timely intervention.

In addition, the intervention incorporates individualized nutritional support based on NRS-2002 or PG-SGA assessment, exercise rehabilitation programs, and structured psychological assessment and intervention using PHQ-2, GAD-2, PHQ-9, and GAD-7 scales. A remote follow-up system and rapid access pathway for adverse event management are also implemented.

The primary outcome measure is the incidence of grade ≥3 treatment-related adverse events, assessed according to CTCAE version 5.0. Secondary outcomes include medication adherence measured by the Morisky Medication Adherence Scale (MMAS-8), completion rate of four treatment cycles, quality of life assessed using the EORTC QLQ-C30, and tumor response evaluated by RECIST version 1.1 criteria.

This study aims to determine whether MDT-based nursing intervention can improve treatment safety, adherence, quality of life, and short-term clinical outcomes compared with routine nursing care in patients with advanced SCLC.

This study was approved by the Ethics Committee of Shanxi Cancer Hospital (Approval No. KY2023119), and written informed consent was obtained from all participants prior to enrollment. The study was completed prior to registration, and trial registration was conducted retrospectively to ensure transparency and compliance with international publication requirements.

Inclusion Criteria:

• Histologically or clinically confirmed small cell lung cancer (SCLC).
• Stage IIIb-IV disease not suitable for surgical treatment.
• Planned to receive first-line platinum-based chemotherapy combined with immunotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Age ≥18 years.
• Estimated life expectancy ≥6 months.
• Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

• Severe cardiac, hepatic, or renal dysfunction.
• Active infection requiring systemic treatment.
• Known immunodeficiency or autoimmune disease requiring immunosuppressive therapy.
• Prior systemic anti-tumor therapy.
• Inability to comply with study procedures or follow-up.

Individual participant data will not be publicly available due to privacy and ethical restrictions but may be available from the corresponding author upon reasonable request.

This is an open-label study due to the nature of the nursing intervention.