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

Completed

• Conditions: Cancer

• Registration Number: NCT02381054
• Lead Sponsor: Italian PRO-CTCAE Study Group

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.

Study Timeline

• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-06
• Study Start: 2015-05
• Primary Completion: 2017-02
• Status Verified: 2017-06
• Study Completion: 2017-06-22
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

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..

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cultural and linguistic validity of Italian language version of the PRO-CTCAE	2 years

Trial Locations

Locations (16)

Ospedale "A.Perrino"; 🇮🇹 Brindisi, Italy

IRCCS Istituto Oncologico"Giovanni Paolo II"; 🇮🇹 Bari, Italy

IRCCS AOU San Martino -IST; 🇮🇹 Genova, Italy

Istituti Ospitalieri; 🇮🇹 Cremona, Italy

AOU Policlinico G.Martino; 🇮🇹 Messina, Italy

Istituto Nazionale Tumori; 🇮🇹 Milano, Italy

IRCCS Policlinico S.Matteo; 🇮🇹 Pavia, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, Italy

A.O. Sant'Andrea; 🇮🇹 Roma, Italy

Ospedale San Camillo Forlanini; 🇮🇹 Roma, Italy

Policlinico Umberto I; 🇮🇹 Roma, Italy

Ospedale Civile SS.Annunziata; 🇮🇹 Sassari, Italy

Ospedale Valdelsa di Poggibonsi; 🇮🇹 Siena, Italy

AOU San Luigi Orbassano; 🇮🇹 Torino, Italy

Policlinico Universitario G.B.Rossi; 🇮🇹 Verona, Italy

Istituto Nazionale Tumori - Fondazione Pascale; 🇮🇹 Napoli, Italy