Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Lung Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorTongji Hospital
Academic / other
Locations1 site (Hubei, Wuhan)
StatusRecruiting
StartedJanuary 4, 2026
Main results expectedOctober 31, 2026
Study endsOctober 31, 2027
Registry record updatedNovember 3, 2026
Trial IDNCT07912190 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.