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NCT07912190
ePRO in Advanced Lung Cancer: Emotional Distress, Symptom Burden, Brain Metastasis
Conditions: Lung Cancer, Brain Metastasis, Patient Reported Outcome
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: Qian Chu
Location: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Hubei Wuhan
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 Criteria
Inclusion Criteria:
1. 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;
2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
3. Age ≥ 18 years old;
4. Estimated survival time ≥ 3 months;
5. Capable and willing to repeatedly complete electronic questionnaires via smartphones or tablets;
6. All enrolled patients signed the hospital-approved informed consent form.
Exclusion Criteria:
1. Prior receipt of anti-tumor treatment;
2. Complicated with severe chronic diseases of the heart, liver, kidney and other vital organs;
3. Abnormal consciousness or mental status;
4. Inability to understand the research content and requirements;
5. A previous medical history of other malignant tumors.
Source: ClinicalTrials.gov (NCT07912190). StuddyBuddy aggregates publicly available trial information.