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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer

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 Type: Observational
• Enrollment (Actual): 233

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy
    • IRCCS Istituto Oncologico"Giovanni Paolo II"
  • Brindisi, Italy
    • Ospedale "A.Perrino"
  • Cremona, Italy
    • Istituti Ospitalieri
  • Genova, Italy
    • IRCCS AOU San Martino -IST
  • Messina, Italy
    • AOU Policlinico G.Martino
  • Milano, Italy
    • Istituto Nazionale Tumori
  • Napoli, Italy
    • Istituto Nazionale Tumori - Fondazione Pascale
  • Padova, Italy
    • Istituto Oncologico Veneto
  • Pavia, Italy
    • IRCCS Policlinico S.Matteo
  • Roma, Italy
    • Policlinico Umberto I
  • Roma, Italy
    • A.O. Sant'Andrea
  • Roma, Italy
    • Ospedale San Camillo Forlanini
  • Sassari, Italy
    • Ospedale Civile SS.Annunziata
  • Siena, Italy
    • Ospedale Valdelsa di Poggibonsi
  • Torino, Italy
    • AOU San Luigi Orbassano
  • Verona, Italy
    • Policlinico Universitario G.B.Rossi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients receiving or having recently received cancer therapy (chemotherapy, biologic therapy, and or radiation therapy) will be recruited from 17 Italian Cancer Institutes and Hospitals throughout Italy. Sampling will be performed to ensure that the target population is matched for gender, age and area of residence (North, center, and Southern Italy). Recruitment of at least 25% of patients with lower levels of educational attainment (i.e., primary school or no education) will also be ensured.

Description

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..

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Translation and cross-cultural adaptation phase; 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; 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	Time Frame
cultural and linguistic validity of Italian language version of the PRO-CTCAE	2 years

Collaborators and Investigators

• Sponsor: Italian PRO-CTCAE Study Group
• Collaborators: Istituti Ospitalieri di Cremona; National Cancer Institute, Naples; IRCCS Policlinico S. Matteo; Parma University Hospital; F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations; SmithKline Foundation; IRCCS AOU San Martino -IST Genoa
• Investigators: Principal Investigator: Rodolfo Passalacqua, Istituti Ospitalieri Cremona; Principal Investigator: Francesco Perrone, National Cancer Institute, Naples; Principal Investigator: Caterina Caminiti, Parma University Hospital; Principal Investigator: Michela Bagnalasta, Smith Kline Foundation; Principal Investigator: Fabio Arpinelli, Smith Kline Foundation; Principal Investigator: Maurizio Bassi, Smith Kline Foundation; Principal Investigator: Pierpaolo Betteto, F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations; Principal Investigator: Lucia Del Mastro, IRCCS AOU San Martino -IST, National Cancer Research Institute; Principal Investigator: Davide De Persis, F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations; Principal Investigator: Elisabetta Iannelli, F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations; Principal Investigator: Anna Lisa Nicelli, Smith Kline Foundation; Principal Investigator: Camillo Porta, Fondazione I.R.C.C.S. Policlinico San Matteo; Principal Investigator: Jane Bryce, National Cancer Institute, Naples

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): June 22, 2017

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Patient reported outcomes
• Other Study ID Numbers: Italian PRO-CTCAE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No