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

NCT07489339 | Completed

• 1 other identifier: SCLC-MDT-2024-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Small Cell Lung Cancer; Multidisciplinary Team; Nursing Intervention; Chemo-Immunotherapy; Immune-Related Adverse Events; Treatment Adherence; Quality of Life; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade ≥3 Treatment-Related Adverse Events

  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.

  Up to 12 weeks (corresponding to 4 cycles of chemo-immunotherapy; each cycle lasts 21 days)

Secondary Outcomes (6)

• 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

• Quality of Life (EORTC QLQ-C30)

  Baseline and 3 months

• Objective Response Rate (ORR)

  At 12 weeks

Study Arms (2)

MDT-Based Nursing Intervention

OTHER

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.

Other: Multidisciplinary Team-Based Nursing Intervention

Routine Nursing Care

OTHER

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.

Other: Routine Nursing Care

Interventions

Multidisciplinary Team-Based Nursing Intervention OTHER

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.

MDT-Based Nursing Intervention

Routine Nursing Care OTHER

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.

Routine Nursing Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanxi Province Cancer Hospital: lead

Study Sites (1)

Shanxi Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, and Cancer Hospital Affiliated to Shanxi Medical University

Taiyuan, Shanxi, 030013, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Health Behavior; Behavior

Study Officials

• Zhiqiang Shi

  Shanxi Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, and Cancer Hospital Affiliated to Shanxi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study due to the nature of the nursing intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1 ratio to either an MDT-based nursing intervention group or a routine care group. Both groups receive the same standard chemo-immunotherapy, while different nursing management strategies are applied. The MDT group receives a structured, multidisciplinary, and protocol-driven nursing intervention, whereas the control group receives routine nursing care.

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 24, 2026
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 30, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)