Small Cell Lung CancerSCLC-MDTNCT07489339
MDT-Based Nursing for Small Cell Lung Cancer During Chemo-Immunotherapy
A study testing Multidisciplinary Team-Based Nursing Intervention and Routine Nursing Care in people with Small Cell Lung Cancer and Extensive-Stage Small Cell Lung Cancer, run by Shanxi Province Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer, Lung Neoplasms
- What is being tested?
- Multidisciplinary Team-Based Nursing Intervention and Routine Nursing Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
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
About this study
Official title: 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
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.
Read more
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.
Read the 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.
- Being tested
- Multidisciplinary Team-Based Nursing Intervention, Routine Nursing Care
- Keywords
- Small Cell Lung Cancer, Multidisciplinary Team, Nursing Intervention, Chemo-Immunotherapy, Immune-Related Adverse Events, Treatment Adherence, Quality of Life, Randomized Controlled Trial
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Team-Based Nursing InterventionOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks (corresponding to 4 cycles of chemo-immunotherapy; each cycle lasts 21 days)
Secondary outcomes (6)
Medication Adherence (MMAS-8 Score)
Medication adherence assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8), with higher scores indicating better adherence.
Measured: At 3 months
Completion Rate of Planned Treatment Cycles
The proportion of patients who completed the planned four cycles of chemo-immunotherapy without discontinuation.
Measured: Up to 12 weeks
Immunotherapy Dose Intensity
The relative dose intensity of immunotherapy administered during the treatment period, expressed as a percentage of the planned dose.
Measured: Up to 12 weeks
Quality of Life (EORTC QLQ-C30)
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.
Measured: Baseline and 3 months
Objective Response Rate (ORR)
The proportion of patients achieving complete response or partial response according to RECIST version 1.1 criteria.
Measured: At 12 weeks
Disease Control Rate (DCR)
The proportion of patients achieving complete response, partial response, or stable disease according to RECIST version 1.1 criteria.
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Jul 2024
- Primary completion1 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanxi Province Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhiqiang Shi, Principal investigator, Shanxi Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, and Cancer Hospital Affiliated to Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489339
- Sponsor's protocol ID
- SCLC-MDT-2024-01
- Acronym
- SCLC-MDT
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available due to privacy and ethical restrictions but may be available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07489339
- Acronym / sponsor ID
- SCLC-MDT / SCLC-MDT-2024-01
- Keywords
- Small Cell Lung Cancer, Multidisciplinary Team, Nursing Intervention, Chemo-Immunotherapy, Immune-Related Adverse Events, Treatment Adherence, Quality of Life, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shanxi Province Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MDT-Based Nursing Intervention | Other | Other: Multidisciplinary Team-Based Nursing InterventionParticipants 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. |
| Routine Nursing Care | Other | Other: Routine Nursing CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary Team-Based Nursing InterventionA 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 | MDT-Based Nursing Intervention |
| Routine Nursing CareRoutine 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. | Other | Routine Nursing Care |
Primary outcome
Incidence of Grade ≥3 Treatment-Related Adverse Events
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.
6 secondary outcomes
Medication Adherence (MMAS-8 Score)
Time frame: At 3 months
Completion Rate of Planned Treatment Cycles
Time frame: Up to 12 weeks
Immunotherapy Dose Intensity
Time frame: Up to 12 weeks
Quality of Life (EORTC QLQ-C30)
Time frame: Baseline and 3 months
Objective Response Rate (ORR)
Time frame: At 12 weeks
Disease Control Rate (DCR)
Time frame: At 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available due to privacy and ethical restrictions but may be available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiqiang Shi principal investigator
Shanxi Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, and Cancer Hospital Affiliated to Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Team-Based Nursing Intervention and Routine Nursing Care in people with Small Cell Lung Cancer and Extensive-Stage Small Cell Lung Cancer, run by Shanxi Province Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade ≥3 Treatment-Related Adverse Events (time frame: Up to 12 weeks (corresponding to 4 cycles of chemo-immunotherapy; each cycle lasts 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.