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

NCT07489339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Shanxi Province Cancer Hospital

    lead OTHER

Principal Investigators

  • Zhiqiang Shi · Shanxi Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, and Cancer Hospital Affiliated to Shanxi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-06-01
Completion
2025-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07489339 on ClinicalTrials.gov