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NCT Number: NCT07131670

Symptoms 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.

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Key information

Conditions

Lung Cancer Chemoradiotherapy Disease Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Patient-Reported Outcomes (PRO) Respiratory Tract Diseases Respiratory Tract Neoplasms Syndrome Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Qian Chu, MD, PhD

CONTACT

[email protected]

027-69378806

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Patient-Reported Outcome Monitoring

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Qian Chu

Other

Registry information

Official study title

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

Acronym: ePRO-LC-CRT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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