Validation of the Italian Version of the PRO-CTCAE

National Cancer Institute, Naples

Status: Enrolling

Conditions: Malignant Neoplasms

Treatments: Other: PRO-CTCAE items

Study type: Observational

Funder types: Other

Identifiers

NCT04416672

VIP

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,675 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.