Ireland
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Recruiting Observational

Symptoms Burden in Lung Cancer Patients Undergoing Definitive Chemoradiotherapy: Insights From Electronic Patient-Reported Outcomes

NCT07131670 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Observational
Started
2024-06-01
Last updated
2025-08-20

Condition(s) studied

Lung CancerChemoradiotherapyPatient-Reported Outcomes (PRO)

Investigational drug(s) / intervention(s)

Electronic Patient-Reported Outcome Monitoring

Electronic Patient-Reported Outcome Monitoring: Participants complete the MDASI-LC and EQ-5D questionnaires electronically on a weekly basis during CRT and for 12 weeks after CRT. The data are used to evaluate symptom burden, symptom clusters, and symptom trajectories.

Study summary

This prospective observational study aims to evaluate symptom burden and symptom clusters among lung cancer patients undergoing definitive concurrent chemoradiotherapy (CRT), based on electronic patient-reported outcomes (ePROs). Patients will complete the validated MDASI-LC and EQ-5D instruments weekly from baseline through the end of CRT and for 12 weeks post-treatment. The study will characterize the longitudinal trajectories of symptom severity and interference, identify distinct symptom clusters and their temporal patterns, and explore patient-level predictors of symptom burden. The findings may support the development of personalized symptom management strategies and improve quality of life during and after CRT.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Pathologically confirmed unresectable stage III NSCLC or limited-stage SCLC * Age ≥ 18 years * Receiving definitive chemoradiotherapy * Able and willing to complete electronic questionnaires * Provided written informed consent Exclusion Criteria: * Severe comorbidities (heart, liver, kidney) * Psychiatric illness or cognitive impairment * Prior chest or mediastinal radiotherapy

Primary outcome measure(s)

  • Longitudinal trajectory of symptom burden over time based on M. D. Anderson Symptom Inventory-Lung Cancer — Baseline, weekly during CRT (weeks 1-6), and weekly for 12 weeks after CRT.
    M. D. Anderson Symptom Inventory-Lung Cancer:Scale range 0-10, with higher scores indicating worse symptom burden.

Trial sites (1)

FacilityCityRegionStatus
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07131670 on ClinicalTrials.gov ↗ ← All trials in China