Symptoms Burden in Lung Cancer Patients Undergoing Definitive Chemoradiotherapy: Insights From Electronic Patient-Reported Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electronic Patient-Reported Outcome Monitoring.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Chemoradiotherapy, Patient-Reported Outcomes (PRO). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Observational Study on Symptom Burden in Lung Cancer Patients Undergoing Definitive Chemoradiotherapy: Insights From Electronic Patient-Reported Outcomes
Overview
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
- Other 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.
Primary outcome measures
- Longitudinal trajectory of symptom burden over time based on M. D. Anderson Symptom Inventory-Lung Cancer [Time frame: Baseline, weekly during CRT (weeks 1-6), and weekly for 12 weeks after CRT.]
Secondary outcome measures (3)
- Questionnaire response rate [Time frame: From baseline to 12 weeks post-CRT]
- Trajectory of symptom interference over time based on M. D. Anderson Symptom Inventory-Lung Cancer [Time frame: From baseline to 12 weeks post-CRT]
- Change of Quality of life over time [Time frame: From baseline to 12 weeks post-CRT]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07131670 · TJ-IRB20240606