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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
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..

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Translation and cross-cultural adaptation phase<br>In this phase 96 Italian-speaking patients who are receiving cancer treatment or who have completed treatment for cancer within the past six months at one of the participating sites will first be asked to independently complete a series of PRO-CTCAE symptom items in a Patient Questionnaire. Following completion by the participant of the Patient Questionnaire containing PRO-CTCAE items, the interviewer will elicit participants' feedback regarding item comprehension, symptomatic adverse event terms, attribute terms, 7-day recall period, and response options, via a semi-scripted cognitive debriefing interview developed to assure consistency across interviews. | |
| Test-retest phase<br>In this phase a minimum of 59 Italian-speaking patients who are receiving cancer treatment will be asked to independently complete the Italian version PRO-CTCAE questionnaire on 2 consecutive business days. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cultural and linguistic validity of Italian language version of the PRO-CTCAE |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient reported outcomes