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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of Grade ≥3 Treatment-Related Adverse Events
研究概览
简要总结
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.
详细描述
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.
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
盲法说明
This is an open-label study due to the nature of the nursing intervention.
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
- •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-
- •Age ≥18 years.
- •Estimated life expectancy ≥6 months.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •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.
结局指标
主要结局
Incidence of Grade ≥3 Treatment-Related Adverse Events
时间窗: Up to 12 weeks (corresponding to 4 cycles of chemo-immunotherapy; each cycle lasts 21 days)
The proportion of patients experiencing grade 3 or higher treatment-related adverse events during chemo-immunotherapy, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- Quality of Life (EORTC QLQ-C30)(Baseline and 3 months)
- Medication Adherence (MMAS-8 Score)(At 3 months)
- Completion Rate of Planned Treatment Cycles(Up to 12 weeks)
- Immunotherapy Dose Intensity(Up to 12 weeks)
- Objective Response Rate (ORR)(At 12 weeks)
- Disease Control Rate (DCR)(At 12 weeks)