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RecruitingNCT07131670ePRO-LC-CRTUpdated Aug 20, 2025

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

An observational study in Lung Cancer, Chemoradiotherapy and Patient-Reported Outcomes (PRO), sponsored by Qian Chu. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by Qian Chu · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

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

Keywords

  • Symptom Burden
  • Symptom Clusters
  • Electronic Patient-Reported Outcomes
  • MDASI-LC
  • Lung Cancer
  • EQ-5D
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Qian Chu is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed unresectable stage III NSCLC or limited-stage SCLC
  • Age ≥ 18 years
  • Receiving definitive chemoradiotherapy
  • Able and willing to complete electronic questionnaires
  • Provided written

Exclusion criteria

Exclusion Criteria:

  • Severe comorbidities (heart, liver, kidney)
  • Psychiatric illness or cognitive impairment
  • Prior chest or mediastinal radiotherapy
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherElectronic Patient-Reported Outcome Monitoring

    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.

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What researchers measure

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.

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

Secondary outcomes

  1. 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.

    Time frame: From baseline to 12 weeks post-CRT

  2. Trajectory of symptom interference 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 interference

    Time frame: From baseline to 12 weeks post-CRT

  3. 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.

    Time frame: From baseline to 12 weeks post-CRT

07

Study locations

1 of 1 sites recruiting
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07131670
Lead sponsor
Qian Chu
Responsible party
Qian Chu (Professor, Tongji Hospital) — Sponsor-investigator
First posted
Aug 20, 2025
Start date
Jun 1, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Aug 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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