Lung CancerePRO-LC-CRTNCT07131670

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

An observational study of Lung Cancer and Chemoradiotherapy, run by Qian Chu at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Chemoradiotherapy, Patient-Reported Outcomes (PRO)
What is being tested?: Electronic Patient-Reported Outcome Monitoring
How many people: 100 participants
Where: 1 siteChina
Study dates: 1 Jun 2024to 31 Mar 2026
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qian Chu, MD, PhD, 027-69378806, qchu@hust.edu.cn
Recruiting

Other trials in China

About this study

Official title: 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.

Conditions: Lung Cancer, Chemoradiotherapy, Patient-Reported Outcomes (PRO)
Being tested: Electronic Patient-Reported Outcome Monitoring
Keywords: Symptom Burden, Symptom Clusters, Electronic Patient-Reported Outcomes, MDASI-LC, Lung Cancer, EQ-5D
Medical subject headings: Lung Neoplasms, Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electronic Patient-Reported Outcome MonitoringOther
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Longitudinal trajectory of symptom burden over time based on M. D. Anderson Symptom Inventory-Lung Cancer
1. D. Anderson Symptom Inventory-Lung Cancer:Scale range 0-10, with higher scores indicating worse symptom burden.
Measured: Baseline, weekly during CRT (weeks 1-6), and weekly for 12 weeks after CRT.

Secondary outcomes (3)

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.
Measured: From baseline to 12 weeks post-CRT
Trajectory of symptom interference over time based on M. D. Anderson Symptom Inventory-Lung Cancer
1. D. Anderson Symptom Inventory-Lung Cancer: scale range 0-10, with higher scores indicating worse interference
Measured: From baseline to 12 weeks post-CRT
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.
Measured: From baseline to 12 weeks post-CRT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202431 Mar 2026

First posted20 Aug 2025
Study start1 Jun 2024
Primary completion31 Dec 2025 (estimated)
Study completion31 Mar 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07131670
Sponsor's protocol ID: TJ-IRB20240606
Acronym: ePRO-LC-CRT
Status last verified: Aug 2025
First submitted: 6 Aug 2025
Last updated: 20 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No