Translation, Cross-cultural Adaptation and Validation of PRO-CTCAE for Italian-speaking Cancer Patients
NCT ID: NCT02381054
Last Updated: 2017-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
233 participants
OBSERVATIONAL
2015-05-31
2017-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ≥18 years of age
* able to speak and understand Italian
* providing written informed consent
* ≥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
Eligibility Criteria for Validation phase:
* 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..
18 Years
ALL
No
Sponsors
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National Cancer Institute, Naples
OTHER
F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations
UNKNOWN
SmithKline Foundation
UNKNOWN
Parma University Hospital
OTHER
IRCCS AOU San Martino -IST Genoa
UNKNOWN
Istituti Ospitalieri di Cremona
OTHER
Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Italian PRO-CTCAE Study Group
OTHER
Responsible Party
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Principal Investigators
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Francesco Perrone
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Caterina Caminiti
Role: PRINCIPAL_INVESTIGATOR
Parma University Hospital
Michela Bagnalasta
Role: PRINCIPAL_INVESTIGATOR
Smith Kline Foundation
Fabio Arpinelli
Role: PRINCIPAL_INVESTIGATOR
Smith Kline Foundation
Maurizio Bassi
Role: PRINCIPAL_INVESTIGATOR
Smith Kline Foundation
Pierpaolo Betteto
Role: PRINCIPAL_INVESTIGATOR
F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations
Lucia Del Mastro
Role: PRINCIPAL_INVESTIGATOR
IRCCS AOU San Martino -IST, National Cancer Research Institute
Davide De Persis
Role: PRINCIPAL_INVESTIGATOR
F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations
Elisabetta Iannelli
Role: PRINCIPAL_INVESTIGATOR
F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations
Anna Lisa Nicelli
Role: PRINCIPAL_INVESTIGATOR
Smith Kline Foundation
Rodolfo Passalacqua
Role: PRINCIPAL_INVESTIGATOR
Istituti Ospitalieri Cremona
Camillo Porta
Role: PRINCIPAL_INVESTIGATOR
Fondazione I.R.C.C.S. Policlinico San Matteo
Jane Bryce
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Locations
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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
Milan, , Italy
Istituto Nazionale Tumori - Fondazione Pascale
Napoli, , Italy
Istituto Oncologico Veneto
Padua, , 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, , Italy
Countries
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Other Identifiers
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Italian PRO-CTCAE
Identifier Type: -
Identifier Source: org_study_id
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