ePRO in advanced lung cancer: emotional distress, brain metastasis, and symptom burden
Official title: A Study on the Correlation of Emotional Distress and Symptom Burden With Brain Metastasis Status in Patients With Advanced Lung Cancer Based on Electronic Patient-reported Outcomes
Run by Tongji Hospital · NCT07912190 · Data updated 2026-11-12
This study tests how patients with advanced lung cancer—some with brain metastases—report emotional distress and symptoms over time using electronic questionnaires.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Hubei, Wuhan) |
| Status | Recruiting |
| Started | January 4, 2026 |
| Main results expected | October 31, 2026 |
| Study ends | October 31, 2027 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07912190 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with stage IV NSCLC or SCLC, ECOG ≤ 2, with or without brain metastases, able to complete electronic PROs, and expected to survive at least 3 months.
✕Probably not a fit
Patients unable or unwilling to complete electronic PROs or with factors preventing reliable reporting may receive limited benefit from this observational study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows patients with advanced lung cancer, with or without brain metastases, to track emotional distress and symptom burden during first-line and maintenance treatment. It uses patient-reported outcomes collected over time to identify symptom clusters and how these change longitudinally. The study also examines how brain metastasis status relates to emotional distress and symptom trajectories. Participants are divided into three cohorts (no brain metastasis, stable brain metastasis, progressive brain metastasis) and compared on symptom patterns and their correlations with brain metastasis. Analyses focus on descriptive trajectories and subgroup differences to improve understanding of symptom experiences in this population.
Why it matters
Potential benefit: If successful, the study could clarify how brain metastasis influences emotional distress and symptom clusters, informing more tailored supportive care.
How similar studies have gone: Prior studies with electronic PROs have shown value in characterizing symptom burden; this study builds on that approach in a brain metastasis–inclusive, longitudinal framework.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan, China Recruiting
Study contacts
- Study coordinator: Qian chu Qian chu, Doctor of Medicine
- Email: qchu@hust.edu.cn
- Phone: 027-69378806
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.