Validation of the Italian Version of the PRO-CTCAE

  • STATUS
    Recruiting
  • participants needed
    3675
  • sponsor
    National Cancer Institute, Naples
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Updated on 19 February 2024
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cancer

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.

Description

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

Details
Condition Cancer
Age 18years - 100years
Treatment PRO-CTCAE items
Clinical Study IdentifierNCT04416672
SponsorNational Cancer Institute, Naples
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Diagnosis of any type of cancer
years of age
Female or male
With at least two planned clinic visits (a return visit within 3-6 weeks) to avoid the need of extra visits
Actively receiving treatment for cancer (going to receive the second or further cycle)
Any ECOG performance status (PS)
Able to complete questionnaire by themselves or with assistance, by using a tablet
Able to speak and understand Italian
Providing informed written consent

Exclusion Criteria

Having any kind of psychiatric disorder or major cognitive dysfunction hampering the provision of informed consent
Having received more than 5lines of therapies
Currently participating in other trials which imply the completion of Patient Reported Outcomes (PROs) in the same period
Other important acute medical conditions
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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