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Life sciences · Observational Study
ClinicalTrials.gov · November 3, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07912190). This is a study registration, not published results. Lead sponsor: Qian Chu. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Lung Cancer, Brain Metastasis, Patient Reported Outcome. Interventions: OTHER: Patient reported outcome. Primary outcome measures: 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 , 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.. Brief 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 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.