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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Patient-Reported Outcome Monitoring | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal trajectory of symptom burden over time based on M. D. Anderson Symptom Inventory-Lung Cancer | M. D. Anderson Symptom Inventory-Lung Cancer:Scale range 0-10, with higher scores indicating worse symptom burden. | Baseline, weekly during CRT (weeks 1-6), and weekly for 12 weeks after CRT. |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire response rate | The response rate of the M. D. Anderson Symptom Inventory-Lung Cancer( MDASI-LC) questionnaire will be assessed weekly during chemoradiotherapy (CRT) and up to 12 weeks post-CRT. This measure will reflect the percentage of patients who completed the MDASI-LC questionnaire each week, with higher response rates indicating better engagement and data quality. | From baseline to 12 weeks post-CRT |
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Inclusion Criteria:
Exclusion Criteria:
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Lung cancer patients aged ≥18 years scheduled to receive definitive chemoradiotherapy at Tongji Hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2024 | Aug 12, 2025 |
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| Trajectory of symptom interference over time based on M. D. Anderson Symptom Inventory-Lung Cancer | M. D. Anderson Symptom Inventory-Lung Cancer: scale range 0-10, with higher scores indicating worse interference | From baseline to 12 weeks post-CRT |
| Change of Quality of life over time | Quality of life will be assessed using the EuroQoL-5 Dimension Health Outcome Survey (EQ-5D) Questionnaire, a widely used instrument for measuring general health status. The EQ-5D includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The change in scores will be evaluated from baseline to 12 weeks after completion of chemoradiotherapy . Higher scores on the EQ-5D reflect better quality of life. | From baseline to 12 weeks post-CRT |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D013577 | Syndrome |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004194 | Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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