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.
Trial 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). Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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
- 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
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.
- 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
- 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
- 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Qian Chu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qian Chu, Tongji Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on Symptom Burden in Lung Cancer Patients Undergoing Definitive Chemoradiotherapy: Insights From Electronic Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT07131670
- Acronym / sponsor ID
- ePRO-LC-CRT / TJ-IRB20240606
- Keywords
- Symptom Burden, Symptom Clusters, Electronic Patient-Reported Outcomes, MDASI-LC, Lung Cancer, EQ-5D
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qian ChuUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients aged ≥18 years scheduled to receive definitive chemoradiotherapy at Tongji Hospital.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Severe comorbidities (heart, liver, kidney)
- Psychiatric illness or cognitive impairment
- Prior chest or mediastinal radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Patient-Reported Outcome MonitoringParticipants 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. | Other | – |
Primary outcome
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.
3 secondary outcomes
Questionnaire response rate
Time frame: 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
Change of Quality of life over time
Time frame: From baseline to 12 weeks post-CRT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Chemoradiotherapy, run by Qian Chu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.