Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive-Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multidisciplinary Team-Based Nursing Intervention | Other | — | UNRESOLVED |
| Routine Nursing Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- MDT-Based Nursing Intervention
- description
- Participants receive a structured multidisciplinary team (MDT)-based nursing intervention in addition to standard chemo-immunotherapy. The MDT intervention includes coordinated care by oncology nurses, oncologists, a clinical pharmacist, a nutritionist, and a psychologist. Key components include systematic monitoring and early management of immune-related adverse events, adherence support, individualized nutritional and exercise interventions, psychological assessment and counseling, and structured follow-up and early warning systems.
- interventionNames
- Other: Multidisciplinary Team-Based Nursing Intervention
- type
- OTHER
- label
- Routine Nursing Care
- description
- Participants receive routine nursing care in addition to standard chemo-immunotherapy. Routine care includes general health education, basic monitoring during treatment, standard post-treatment observation, and conventional supportive care without a structured multidisciplinary intervention.
- interventionNames
- Other: Routine Nursing Care
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available