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Validation of the Italian Version of the PRO-CTCAE

NCT04416672 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3675

Last updated 2023-03-24

No results posted yet for this study

Summary

The aim of this study is to complete the validation process by testing the remaining two psychometric properties (validity and responsiveness) of the Italian version of the PRO-CTCAE in a large group of patients. In particular, for the first time this study will validate the tool for individual types of cancer and will provide information on psychometric properties based on the type of treatment used in clinical practice.

Conditions

  • Malignant Neoplasms

Interventions

OTHER

PRO-CTCAE items

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: * the European Organisation for Research and Treatment of Cancer (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.

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Francesco Perrone, MD, PhD · Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04416672 on ClinicalTrials.gov