Symptoms Burden in Lung Cancer Patients Undergoing Definitive Chemoradiotherapy: Insights From Electronic Patient-Reported Outcomes (ePRO-LC-CRT)

August 12, 2025 updated by: Qian Chu

A Prospective Observational Study on Symptom Burden in Lung Cancer Patients Undergoing Definitive Chemoradiotherapy: Insights From Electronic Patient-Reported Outcomes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Lung cancer patients aged ≥18 years scheduled to receive definitive chemoradiotherapy at Tongji Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire response rate
Time Frame: 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.
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
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
Time Frame: 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.
From baseline to 12 weeks post-CRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qian Chu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

August 6, 2025

First Submitted That Met QC Criteria

August 12, 2025

First Posted (Actual)

August 20, 2025

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB20240606

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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