Pneumonitis in Older Lung Cancer Patients After Radiotherapy

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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).

Eligibility

Primary outcome measure(s)

• Number of participants with symptomatic radiation pneumonitis (grade ≥2) — start of radiotherapy until 24 weeks following radiotherapy
  Radiation pneumonitis will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Trial sites (5)

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