An observational study in Lung Cancer, Brain Metastasis and Patient Reported Outcome, sponsored by Qian Chu. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Qian Chu · Observational
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Qian Chu is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: from baseline to the 12th month
Plan to share: No — Due to patient and hospital ethical requirements, this project does not currently meet the criteria for Individual Patient Data (IPD).
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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