Symptoms Burden in Lung Cancer Patients Undergoing Definitive Chemoradiotherapy: Insights From Electronic Patient-Reported Outcomes

NCT07131670 | Recruiting

• 1 other identifier: TJ-IRB20240606
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer; Chemoradiotherapy; Patient-Reported Outcomes (PRO)

Keywords

Symptom Burden; Symptom Clusters; Electronic Patient-Reported Outcomes; MDASI-LC; Lung Cancer; EQ-5D

Outcome Measures

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.

  Baseline, weekly during CRT (weeks 1-6), and weekly for 12 weeks after CRT.

Secondary Outcomes (3)

• Questionnaire response rate

  From baseline to 12 weeks post-CRT

• Trajectory of symptom interference over time based on M. D. Anderson Symptom Inventory-Lung Cancer

  From baseline to 12 weeks post-CRT

• Change of Quality of life over time

  From baseline to 12 weeks post-CRT

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Severe comorbidities (heart, liver, kidney)
• Psychiatric illness or cognitive impairment
• Prior chest or mediastinal radiotherapy

Sponsors & Collaborators

• Qian Chu: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 20, 2025
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

CN (1)