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

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..