ePRO in Advanced Lung Cancer: Emotional Distress, Symptom Burden, Brain Metastasis

Condition(s) studied

Investigational drug(s) / intervention(s)

Patient reported outcome: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
  MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC): The scale ranges from 0 to 10, with higher scores indicating greater symptom burden.

Trial sites (1)

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