Validation of the Italian Version of the PRO-CTCAE

Launched by NATIONAL CANCER INSTITUTE, NAPLES · Jun 3, 2020

Keywords

ClinConnect Summary

This clinical trial is focused on testing a tool called the PRO-CTCAE, which helps gather information about how patients with cancer are feeling during their treatment. The researchers want to make sure that this Italian version of the tool is reliable and effective, especially for different types of cancer and treatments. By participating in this study, patients can help improve the way healthcare providers understand and respond to their needs during treatment.

To be eligible for this trial, participants must be adults aged 18 or older, diagnosed with any type of cancer, and currently undergoing treatment. They should have at least two planned visits to the clinic and be able to complete a questionnaire about their experiences, either on their own or with some help. It’s important that participants can speak and understand Italian and provide consent to take part in the study. Those with severe psychiatric issues or who have had extensive prior treatments may not be eligible. Participants can expect to share their experiences, which will contribute to better patient care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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.