Lung CancerePRO-BM-LCNCT07912190
ePRO in Advanced Lung Cancer: Emotional Distress, Symptom Burden, Brain Metastasis
An observational study of Lung Cancer and Brain Metastasis, run by Qian Chu at 1 site in China.
Trial summary
This study intends to adopt a prospective longitudinal research design to comprehensively evaluate patient-reported emotional stress and symptom burden in patients with advanced lung cancer and lung cancer brain metastasis during first-line and maintenance treatment, extract symptom clusters, and describe the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Brain Metastasis, Patient Reported Outcome
- What is being tested?
- Patient reported outcome
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2026to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Outpatients and inpatients with a clear diagnosis of advanced lung cancer and lung cancer brain metastasis will be recruited from the Department of Thoracic Oncology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Xiangyang Central Hospital, and Xiangyang No.1 People's Hospital, with an age of ≥ 18 years old.
Who may be able to join
- Non-brain metastasis cohort: patients with stage IV non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) confirmed by pathology and imaging, without brain metastasis; Brain metastasis cohort: patients with pathologically and radiologically confirmed stage IV NSCLC and SCLC accompanied by brain metastasis;
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
- Age ≥ 18 years old;
- Estimated survival time ≥ 3 months;
- Capable and willing to repeatedly complete electronic questionnaires via smartphones or tablets;
- All enrolled patients signed the hospital-approved informed consent form.
Who cannot join
- Prior receipt of anti-tumor treatment;
- Complicated with severe chronic diseases of the heart, liver, kidney and other vital organs;
- Abnormal consciousness or mental status;
- Inability to understand the research content and requirements;
- A previous medical history of other malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan, 430030
Qian chu Qian chu, Doctor of Medicine, 027-69378806, qchu@hust.edu.cn
About this study
Official title: A Study on the Correlation of Emotional Distress and Symptom Burden With Brain Metastasis Status in Patients With Advanced Lung Cancer Based on Electronic Patient-reported Outcomes
This study intends to adopt a prospective longitudinal research design to comprehensively evaluate patient-reported emotional stress and symptom burden in patients with advanced lung cancer and lung cancer brain metastasis during first-line and maintenance treatment, extract symptom clusters, and describe the longitudinal dynamic trajectories of symptoms and symptom clusters over time. Meanwhile, it analyzes the relationships between brain metastasis and emotional stress as well as symptom trajectories.
Patients will be divided into three cohorts according to the status of brain metastasis: non-metastasis, stable brain metastasis, and progressive brain metastasis. Differences in emotional stress, symptom burden and symptom cluster manifestations among subgroups will be further compared, together with their correlations with brain metastasis. This study aims to improve the understanding of the characteristics of symptom burden and symptom cluster profiles mediated by emotional stress in lung cancer patients throughout treatment.
- Conditions
- Lung Cancer, Brain Metastasis, Patient Reported Outcome
- Being tested
- Patient reported outcome
- Keywords
- Emotional distress, brain metastasis, lung cancer, symptom burden, Patient reported outcome
- Medical subject headings
- Lung Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient reported outcomeOther
Patients enrolled in this study completed the MDASI-LC and EQ-5D questionnaires via WeChat mini-programs on mobile phones, tablets or computers at 1-2 days before treatment initiation (baseline), every 4 weeks within the first six months of treatment, and every 8 weeks thereafter until disease progression.
Specifically, for the non-brain metastasis cohort, the endpoint was the development of brain metastasis; for the brain metastasis cohort, the endpoint was disease progression. The assessment frequency was once every 4 weeks in the first six months and once every 8 weeks after six months.
What is being measured
The primary outcome is the main question the study is designed to answer.
To clarify the number of symptom clusters, changes in emotional stress, the composition of symptoms within each cluster, and their dynamic temporal trends during treatment
MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC): The scale ranges from 0 to 10, with higher scores indicating greater symptom burden.
Measured: Completed 1-2 days before treatment initiation; assessments were conducted every 4 weeks in the first six months after treatment, and every 8 weeks thereafter until disease progression.
Secondary outcomes (3)
questionnaire response rate
The response rate of the MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) will be assessed every 4 weeks within the first six months of treatment and every 8 weeks thereafter until disease progression. This indicator reflects the proportion of patients who complete the MDASI-LC at each time point. A higher response rate indicates better participant engagement and superior data quality.
Measured: from baseline to the 12th month
The correlations of patients' emotional stress status and symptom severity scores with brain metastasis and PFS
Patients completed the MDASI-LC, PHQ-9 and GAD-7 scales from baseline to month 12. Meanwhile, the correlations between relevant indicators and patients' PFS were analyzed.
Measured: from baseline to the 12th month
changes in quality of life over time
Quality of life will be assessed using the EuroQol 5-Dimension Health Questionnaire (EQ-5D), a widely validated tool for measuring general health status. The EQ-5D covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Changes in scores will be evaluated from baseline to 12 weeks after the completion of chemotherapy. Higher EQ-5D scores indicate a better quality of life.
Measured: from baseline to the 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start4 Jan 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qian Chu
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangyang No.1 People's Hospital, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
- Responsible party
- Sponsor-investigator, Qian Chu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912190
- Sponsor's protocol ID
- TJ-IRB202512127
- Acronym
- ePRO-BM-LC
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient and hospital ethical requirements, this project does not currently meet the criteria for Individual Patient Data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Correlation of Emotional Distress and Symptom Burden With Brain Metastasis Status in Patients With Advanced Lung Cancer Based on Electronic Patient-reported Outcomes
- ClinicalTrials.gov ID
- NCT07912190
- Acronym / sponsor ID
- ePRO-BM-LC / TJ-IRB202512127
- Conditions
- Lung Cancer, Brain Metastasis, Patient Reported Outcome
- Keywords
- Emotional distress, brain metastasis, lung cancer, symptom burden, Patient reported outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qian ChuUniversity, hospital or other
- Collaborators
- Xiangyang No.1 People's Hospital, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
- Study start
- 4 Jan 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 3 Nov 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 intends to adopt a prospective longitudinal research design to comprehensively evaluate patient-reported emotional stress and symptom burden in patients with advanced lung cancer and lung cancer brain metastasis during first-line and maintenance treatment, extract symptom clusters, and describe the longitudinal dynamic trajectories of symptoms and symptom clusters over time. Meanwhile, it analyzes the relationships between brain metastasis and emotional stress as well as symptom trajectories.
Patients will be divided into three cohorts according to the status of brain metastasis: non-metastasis, stable brain metastasis, and progressive brain metastasis. Differences in emotional stress, symptom burden and symptom cluster manifestations among subgroups will be further compared, together with their correlations with brain metastasis. This study aims to improve the understanding of the characteristics of symptom burden and symptom cluster profiles mediated by emotional stress in lung cancer patients throughout treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients and inpatients with a clear diagnosis of advanced lung cancer and lung cancer brain metastasis will be recruited from the Department of Thoracic Oncology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Xiangyang Central Hospital, and Xiangyang No.1 People's Hospital, with an age of ≥ 18 years old.
Key inclusion criteria (6 listed)
- Non-brain metastasis cohort: patients with stage IV non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) confirmed by pathology and imaging, without brain metastasis; Brain metastasis cohort: patients with pathologically and radiologically confirmed stage IV NSCLC and SCLC accompanied by brain metastasis;
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
- Age ≥ 18 years old;
- Estimated survival time ≥ 3 months;
- Capable and willing to repeatedly complete electronic questionnaires via smartphones or tablets;
Key exclusion criteria (5 listed)
- Prior receipt of anti-tumor treatment;
- Complicated with severe chronic diseases of the heart, liver, kidney and other vital organs;
- Abnormal consciousness or mental status;
- Inability to understand the research content and requirements;
- A previous medical history of other malignant tumors.
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 |
|---|---|---|
| Patient reported outcomePatients enrolled in this study completed the MDASI-LC and EQ-5D questionnaires via WeChat mini-programs on mobile phones, tablets or computers at 1-2 days before treatment initiation (baseline), every 4 weeks within the first six months of treatment, and every 8 weeks thereafter until disease progression. Specifically, for the non-brain metastasis cohort, the endpoint was the development of brain metastasis; for the brain metastasis cohort, the endpoint was disease progression. The assessment frequency was once every 4 weeks in the first six months and once every 8 weeks after six months. | Other | – |
Primary outcome
To clarify the number of symptom clusters, changes in emotional stress, the composition of symptoms within each cluster, and their dynamic temporal trends during treatment
Time frame: Completed 1-2 days before treatment initiation; assessments were conducted every 4 weeks in the first six months after treatment, and every 8 weeks thereafter until disease progression.
MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC): The scale ranges from 0 to 10, with higher scores indicating greater symptom burden.
3 secondary outcomes
questionnaire response rate
Time frame: from baseline to the 12th month
The correlations of patients' emotional stress status and symptom severity scores with brain metastasis and PFS
Time frame: from baseline to the 12th month
changes in quality of life over time
Time frame: from baseline to the 12th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. Due to patient and hospital ethical requirements, this project does not currently meet the criteria for Individual Patient Data (IPD).
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Brain Metastasis, run by Qian Chu 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 6 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: looking for participants now, as of the sponsor's last update on 3 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian chu Qian chu, Doctor of Medicine (027-69378806, qchu@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To clarify the number of symptom clusters, changes in emotional stress, the composition of symptoms within each cluster, and their dynamic temporal trends during treatment (time frame: Completed 1-2 days before treatment initiation; assessments were conducted every 4 weeks in the first six months after treatment, and every 8 weeks thereafter until disease progression.). 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 3 Nov 2026.