Symptoms Burden in Lung Cancer Patients Undergoing Definitive Chemoradiotherapy: Insights From Electronic Patient-Reported Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQian Chu
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed unresectable stage III NSCLC or limited-stage SCLC
Age ≥ 18 years
Receiving definitive chemoradiotherapy
Able and willing to complete electronic questionnaires
Disqualifiers
Severe comorbidities (heart, liver, kidney)
Psychiatric illness or cognitive impairment
Prior chest or mediastinal radiotherapy
Trial population
Lung cancer patients aged ≥18 years scheduled to receive definitive chemoradiotherapy at Tongji Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Electronic Patient-Reported Outcome Monitoring
Other interventionParticipants 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, weekly during CRT (weeks 1-6), and weekly for 12 weeks after CRT.Secondary outcomes
1
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.
Time frame
From baseline to 12 weeks post-CRT2
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
Time frame
From baseline to 12 weeks post-CRT3
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.
Time frame
From baseline to 12 weeks post-CRTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Qian Chu
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov