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Pneumonitis in Older Lung Cancer Patients After Radiotherapy
Sponsor: University Hospital Schleswig-Holstein
Summary
The main goal of this trial is to establish the performance characteristics and to develop a decision-algorithm of a new symptom-based scoring system with respect to the identification of elderly lung cancer patients developing pneumonitis after radiotherapy. To assess the performance characteristics of the symptom-based scoring system for detection of radiation pneumonitis the receiver operating characteristic (ROC) curve is used to show the connection between sensitivity and specificity for every possible cut-off for the symptom-based scoring system and to select the optimal scoring point for detection of radiation pneumonitis. The area under the ROC curve (AUC) is calculated to prove the diagnostic ability of the scoring system. Secondary aims include patient satisfaction with the symptom-based scoring system (symptom-questionnaire, paper version).
Official title: Pneumonitis in Older Lung Cancer Patients After Radiotherapy: a Scoring System for Identification of Pneumonitis in Elderly Patients Irradiated for Lung Cancer
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2024-11-06
Completion Date
2026-06-30
Last Updated
2025-01-16
Healthy Volunteers
No
Conditions
Interventions
symptom-based scoring system (symptom-questionnaire, paper version)
The patients are asked to complete a paper-based questionnaire (symptom-based scoring system, paper version) once a week during and up to 24 weeks following radiotherapy. The patients state and score symptoms potentially associated with pneumonitis, namely cough, shortness of breath and fever. Scoring points are assigned to severity of the symptoms, and sum scores are used to identify pneumonitis. During the radiotherapy course, patients complete the questionnaire prior to regular appointments with a physician. Following radiotherapy, they are contacted by phone (to minimize the number of hospital visits) once a week for completion of the questionnaire. In case of an increase of the total score when compared to baseline, patients receive a follow-up phone call after 3 days, are asked to come to the hospital as outpatients or are admitted to hospital.
Locations (5)
Vejle Hospital, University Hospital of Southern Denmark
Vejle, Southern Denmark, Denmark
Medical Practice for Radiotherapy and Radiation Oncology
Hanover, Lower Saxony, Germany
Medical School Hamburg, Schwerin Campus
Schwerin, Mecklenburg-Vorpommern, Germany
Malteser Hospital St. Franziskus
Flensburg, Schleswig-Holstein, Germany
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany