Clinical trial · Observational
Symptoms Burden in Lung Cancer Patients Undergoing Definitive Chemoradiotherapy: Insights From Electronic Patient-Reported Outcomes
A Prospective Observational Study on Symptom Burden in Lung Cancer Patients Undergoing Definitive Chemoradiotherapy: Insights From Electronic Patient-Reported Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiotherapy | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Patient-Reported Outcomes (PRO) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic Patient-Reported Outcome Monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Longitudinal trajectory of symptom burden over time based on M. D. Anderson Symptom Inventory-Lung Cancer
- timeFrame
- Baseline, weekly during CRT (weeks 1-6), and weekly for 12 weeks after CRT.
- description
- M. D. Anderson Symptom Inventory-Lung Cancer:Scale range 0-10, with higher scores indicating worse symptom burden.
Secondary outcomes (3)
- measure
- Questionnaire response rate
- timeFrame
- From baseline to 12 weeks post-CRT
- description
- 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.
- measure
- Trajectory of symptom interference over time based on M. D. Anderson Symptom Inventory-Lung Cancer
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available