MDT-Based Nursing for Small Cell Lung Cancer During Chemo-Immunotherapy (NCT07489339) | Clinical Trial Compass
CompletedNot Applicable
MDT-Based Nursing for Small Cell Lung Cancer During Chemo-Immunotherapy
China200 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Grade ≥3 Treatment-Related Adverse Events
Timeframe: Up to 12 weeks (corresponding to 4 cycles of chemo-immunotherapy; each cycle lasts 21 days)