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
NCT Number: NCT07489339
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.
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All sexes
Interventional
Not applicable
Taiyuan, Shanxi, 030013, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: At 3 months
Medication adherence assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8), with higher scores indicating better adherence.
Time frame: Up to 12 weeks
The proportion of patients who completed the planned four cycles of chemo-immunotherapy without discontinuation.
Time frame: Up to 12 weeks
The relative dose intensity of immunotherapy administered during the treatment period, expressed as a percentage of the planned dose.
Time frame: 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.
Time frame: At 12 weeks
The proportion of patients achieving complete response or partial response according to RECIST version 1.1 criteria.
Time frame: At 12 weeks
The proportion of patients achieving complete response, partial response, or stable disease according to RECIST version 1.1 criteria.
Shanxi Province Cancer Hospital
Other
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
Acronym: SCLC-MDT
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