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

NCT ID: NCT07131670

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer Chemoradiotherapy Patient-Reported Outcomes (PRO)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Electronic 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qian Chu

OTHER

Sponsor Role lead

Responsible Party

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Qian Chu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Qian Chu, MD, PhD

Role: primary

027-69378806

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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TJ-IRB20240606

Identifier Type: -

Identifier Source: org_study_id

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