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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Italian PRO-CTCAE Study Group
- Enrollment
- 233
- Locations
- 16
- Primary Endpoint
- cultural and linguistic validity of Italian language version of the PRO-CTCAE
- Status
- Completed
- Last Updated
- 8 years ago
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.
Investigators
Eligibility Criteria
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..
Outcomes
Primary Outcomes
cultural and linguistic validity of Italian language version of the PRO-CTCAE
Time Frame: 2 years