NCT07912190 ePRO in Advanced Lung Cancer: Emotional Distress, Symptom Burden, Brain Metastasis
| NCT ID | NCT07912190 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qian Chu |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-01-04 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-01-04 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07912190 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07912190 currently recruiting?
Yes, NCT07912190 is actively recruiting participants. Contact the research team at qchu@hust.edu.cn for enrollment information.
Where is the NCT07912190 trial being conducted?
This trial is being conducted at Hubei, China.
Who is sponsoring the NCT07912190 clinical trial?
NCT07912190 is sponsored by Qian Chu. The trial plans to enroll 200 participants.
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