Clinical trial NCT02381054: Translation, Cross-cultural Adaptation and Validation of PRO-CTCAE for Italian-speaking Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Patient reported outcomes
Lead sponsor: Italian PRO-CTCAE Study Group
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, Naples
name: F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations
name: SmithKline Foundation
name: Parma University Hospital
name: IRCCS AOU San Martino -IST Genoa
name: Istituti Ospitalieri di Cremona
name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2015-03-06
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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..

Primary outcomes:
measure: cultural and linguistic validity of Italian language version of the PRO-CTCAE
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: IRCCS Istituto Oncologico"Giovanni Paolo II"
city: Brindisi
country: Italy
facility: Ospedale "A.Perrino"
city: Cremona
country: Italy
facility: Istituti Ospitalieri
city: Genova
country: Italy
facility: IRCCS AOU San Martino -IST
city: Messina
country: Italy
facility: AOU Policlinico G.Martino
city: Milano
country: Italy
facility: Istituto Nazionale Tumori
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori - Fondazione Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Pavia
country: Italy
facility: IRCCS Policlinico S.Matteo
city: Roma
country: Italy
facility: A.O. Sant'Andrea
city: Roma
country: Italy
facility: Ospedale San Camillo Forlanini
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Sassari
country: Italy
facility: Ospedale Civile SS.Annunziata
city: Siena
country: Italy
facility: Ospedale Valdelsa di Poggibonsi
city: Torino
country: Italy
facility: AOU San Luigi Orbassano
city: Verona
country: Italy
facility: Policlinico Universitario G.B.Rossi
Study officials:
affiliation: National Cancer Institute, Naples
name: Francesco Perrone
role: PRINCIPAL_INVESTIGATOR
affiliation: Parma University Hospital
name: Caterina Caminiti
role: PRINCIPAL_INVESTIGATOR
affiliation: Smith Kline Foundation
name: Michela Bagnalasta
role: PRINCIPAL_INVESTIGATOR
affiliation: Smith Kline Foundation
name: Fabio Arpinelli
role: PRINCIPAL_INVESTIGATOR
affiliation: Smith Kline Foundation
name: Maurizio Bassi
role: PRINCIPAL_INVESTIGATOR
affiliation: F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations
name: Pierpaolo Betteto
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS AOU San Martino -IST, National Cancer Research Institute
name: Lucia Del Mastro
role: PRINCIPAL_INVESTIGATOR
affiliation: F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations
name: Davide De Persis
role: PRINCIPAL_INVESTIGATOR
affiliation: F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations
name: Elisabetta Iannelli
role: PRINCIPAL_INVESTIGATOR
affiliation: Smith Kline Foundation
name: Anna Lisa Nicelli
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituti Ospitalieri Cremona
name: Rodolfo Passalacqua
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione I.R.C.C.S. Policlinico San Matteo
name: Camillo Porta
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Jane Bryce
role: PRINCIPAL_INVESTIGATOR
References: