Status:
UNKNOWN
Validation of the Italian Version of the PRO-CTCAE
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Malignant Neoplasms
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Diagnosis of any type of cancer
- •≥18 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
- 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.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
3675 Patients enrolled
Trial Details
Trial ID
NCT04416672
Start Date
July 1 2018
End Date
July 1 2024
Last Update
March 24 2023
Active Locations (25)
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1
Oncologia Medica per la Patologia Toracica- IRCCS Giovanni Paolo II
Bari, Italy
2
U.O.C. Oncologia Medica - Ospedale Senatore Antonio Perrino
Brindisi, Italy
3
Azienda Ospedaliero Universitaria di Cagliar
Cagliari, Italy
4
Oncologia Medica 2 - IRCCS AOU San Martino
Genova, Italy