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

Cancer Clinical Trial

— PRO-CTCAE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381054
• Other study ID #: Italian PRO-CTCAE
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: June 27, 2017
• Start date: May 2015
• Est. completion date: June 22, 2017

Study information

• Verified date: June 2017
• Source: Italian PRO-CTCAE Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: June 22, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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..

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Italy	IRCCS Istituto Oncologico"Giovanni Paolo II"	Bari
Italy	Ospedale "A.Perrino"	Brindisi
Italy	Istituti Ospitalieri	Cremona
Italy	IRCCS AOU San Martino -IST	Genova
Italy	AOU Policlinico G.Martino	Messina
Italy	Istituto Nazionale Tumori	Milano
Italy	Istituto Nazionale Tumori - Fondazione Pascale	Napoli
Italy	Istituto Oncologico Veneto	Padova
Italy	IRCCS Policlinico S.Matteo	Pavia
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

Sponsors (8)

Lead Sponsor	Collaborator
Italian PRO-CTCAE Study Group	F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations, IRCCS AOU San Martino -IST Genoa, IRCCS Policlinico S. Matteo, Istituti Ospitalieri di Cremona, National Cancer Institute, Naples, SmithKline Foundation, University Hospitals Parma Medical Center

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cultural and linguistic validity of Italian language version of the PRO-CTCAE		2 years