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Validation of the Italian Version of the PRO-CTCAE

Validation of the Italian Version of the PRO-CTCAE

Recruiting
18 years and older
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This is a prospective observational study, conducted in Italian cancer centers located Nationwide.

The investigators plan to consider for validation 21tumor sites, which correspond to the conditions for which a specific EORTC module has been produced, plus all remaining cancer types classified as "other setting".

The study will take place during two planned visits, one the first the day of enrollment, the second after 3-6 weeks. Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties:

  • EORTC Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available.
  • the Hospital Anxiety and Depression Scale (HADS)
  • The Patients' Global Impression of Change (PGIC) Scale
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Study details
    Cancer

NCT04416672

National Cancer Institute, Naples

19 February 2024

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