Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer, Lung Neoplasms
Conditions
Keywords
Small Cell Lung Cancer, Multidisciplinary Team, Nursing Intervention, Chemo-Immunotherapy, Immune-Related Adverse Events, Treatment Adherence, Quality of Life, Randomized Controlled Trial
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.
Detailed description
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. This study aims to determine whether MDT-based nursing intervention can improve treatment safety, adherence, quality of life, and short-term clinical outcomes compared with routine nursing care in patients with advanced SCLC. This study was approved by the Ethics Committee of Shanxi Cancer Hospital (Approval No. KY2023119), and written informed consent was obtained from all participants prior to enrollment. The study was completed prior to registration, and trial registration was conducted retrospectively to ensure transparency and compliance with international publication requirements.
Interventions
OTHERMultidisciplinary 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.
OTHERRoutine 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
Shanxi Province Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This is an open-label study due to the nature of the nursing intervention.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade ≥3 Treatment-Related Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence (MMAS-8 Score) | At 3 months | Medication adherence assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8), with higher scores indicating better adherence. |
| Completion Rate of Planned Treatment Cycles | Up to 12 weeks | The proportion of patients who completed the planned four cycles of chemo-immunotherapy without discontinuation. |
| Immunotherapy Dose Intensity | Up to 12 weeks | The relative dose intensity of immunotherapy administered during the treatment period, expressed as a percentage of the planned dose. |
| Quality of Life (EORTC QLQ-C30) | Baseline and 3 months | Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), which includes global health status, functional scales, and symptom scales. Scores range from 0 to 100. Higher scores on global health status and functional scales indicate better quality of life, whereas higher scores on symptom scales indicate worse symptoms. |
| Objective Response Rate (ORR) | At 12 weeks | The proportion of patients achieving complete response or partial response according to RECIST version 1.1 criteria. |
| Disease Control Rate (DCR) | At 12 weeks | The proportion of patients achieving complete response, partial response, or stable disease according to RECIST version 1.1 criteria. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORZhiqiang Shi
Shanxi Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, and Cancer Hospital Affiliated to Shanxi Medical University
Outcome results
None listed