Chemoradiotherapy, Lung Cancer, Patient-Reported Outcomes (PRO)
Conditions
Keywords
Symptom Burden, Symptom Clusters, Electronic Patient-Reported Outcomes, MDASI-LC, Lung Cancer, EQ-5D
Brief 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.
Interventions
OTHERElectronic 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.
Sponsors
Qian Chu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire response rate | From baseline to 12 weeks post-CRT | 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. |
| Trajectory of symptom interference over time based on M. D. Anderson Symptom Inventory-Lung Cancer | From baseline to 12 weeks post-CRT | M. D. Anderson Symptom Inventory-Lung Cancer: scale range 0-10, with higher scores indicating worse interference |
| Change of Quality of life over time | From baseline to 12 weeks post-CRT | 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. |
Countries
China
Outcome results
None listed