NCT07489339Completed
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 · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 19 Mar 2026
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Shanxi Province Cancer Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07489339
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 1 Jul 2024 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic anti-tumor therapy.
Other illness
- Severe cardiac, hepatic, or renal dysfunction.
- Active infection requiring systemic treatment.
- Known immunodeficiency or autoimmune disease requiring immunosuppressive therapy.
Other
- Inability to comply with study procedures or follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanxi Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, and Cancer Hospital Affiliated to Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.