NCT07489339

MDT-Based Nursing for Small Cell Lung Cancer During Chemo-Immunotherapy

Development and Evaluation of a Multidisciplinary Team-Based Nursing Intervention System for Patients With Small Cell Lung Cancer Receiving Chemo-Immunotherapy: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Shanxi Province Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Small Cell Lung Cancer
• Extensive-Stage Small Cell Lung Cancer
• Lung Neoplasms

Interventions

Type	Name	Description
OTHER	Multidisciplinary Team-Based Nursing Intervention	A structured multidisciplinary team (MDT)-based nursing intervention delivered alongside standard chemo-immunotherapy. The MDT team consists of oncology nurses, oncologists, a clinical pharmacist, a nutritionist, and a psychologist. The intervention includes coordinated care planning, systematic monitoring and early management of immune-related adverse events using predefined criteria, adherence assessment and targeted support, individualized nutritional intervention based on validated screening tools, exercise guidance, structured psychological assessment and counseling, and scheduled follow-up with early warning and rapid response mechanisms.
OTHER	Routine Nursing Care	Routine nursing care provided alongside standard chemo-immunotherapy. This includes general health education, basic monitoring during treatment, standard post-treatment observation, and conventional supportive care without a structured multidisciplinary intervention or predefined management protocols.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-06-01
• Completion: 2025-06-30
• First posted: 2026-03-24
• Last updated: 2026-03-30

Locations

1 site across 1 country: China