Translation, Cross-cultural Adaptation and Validation of PRO-CTCAE for Italian-speaking Cancer Patients

Translation, Cross-Cultural Adaptation and Validation of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for Italian-speaking Cancer Patients

The purpose of this study is to see if the Italian language version of a questionnaire about symptoms that patients may have during cancer treatment is understandable to Italian speaking patients. The questionnaire is called the PRO-CTCAE, and was originally developed at the U.S. National Cancer Institute to help get information about patients' symptoms directly from the patients themselves. The Italian version of the questionnaire will be used in future studies to gain a better understanding of patient symptoms.

This study will be conducted in two steps. The first is the Italian translation and cross cultural adaptation of the original US NCI's version of the PRO-CTCAE questionnaire. The questionnaire will be translated and administered to a sample of 96 Italian patients. After protocol amendment in November 2016, the second step was modified and consists of test-retest reliability assessment of the Italian language version of the PRO-CTCAE questionnaire that was developed in the first step, with a minimum of 59 Italian speaking patients to be enrolled. A validation study is planned and will be the subject of a separate protocol.

Eligibility Criteria for cross-cultural adaption phase:

Inclusion criteria:

• patients receiving (or who have received within 6 months) chemotherapy or radiotherapy with curative or palliative intent for an advanced cancer at one of the study sites
• ≥18 years of age
• able to speak and understand Italian
• providing written informed consent

Exclusion criteria:

• Patients judged unable to report on their symptoms from the last seven days due to cognitive impairment.

Eligibility Criteria for Validation phase:

Inclusion Criteria:

• ≥18 years of age.
• Patient is able to complete PRO-CTCAE on two consecutive days.
• Patient is actively receivingmedical treatment for cancer or has completed treatment not more than 4 weeks before Visit 1
• Any type of cancer
• Able to complete questionnaire by themselves or with assistance.
• Providing informed written consent.
• Able to speak and understand Italian

Exclusion Criteria:

• Clinically significant cognitive or memory impairment in the opinion of clinical or research staff.
• Other important acute medical conditions that, in the opinion of the Investigator, may prevent compliance..