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| Name | Class |
|---|---|
| National Cancer Institute, Naples | OTHER |
| F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations | UNKNOWN |
| SmithKline Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| cultural and linguistic validity of Italian language version of the PRO-CTCAE | 2 years |
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Eligibility Criteria for cross-cultural adaption phase:
Inclusion criteria:
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:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Oncologico"Giovanni Paolo II" | Bari | Italy | ||||
| Ospedale "A.Perrino" |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Parma University Hospital |
| OTHER |
| IRCCS AOU San Martino -IST Genoa | UNKNOWN |
| Istituti Ospitalieri di Cremona | OTHER |
| Fondazione IRCCS Policlinico San Matteo di Pavia | OTHER |
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| Anna Lisa Nicelli | Smith Kline Foundation | Principal Investigator |
| Rodolfo Passalacqua | Istituti Ospitalieri Cremona | Principal Investigator |
| Camillo Porta | Fondazione I.R.C.C.S. Policlinico San Matteo | Principal Investigator |
| Jane Bryce | National Cancer Institute, Naples | Principal Investigator |
| 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 | Naples | 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 | Italy |