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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UNKNOWN
3675 participants
OBSERVATIONAL
2018-07-01
2024-07-31
Brief Summary
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Detailed Description
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The investigators plan to consider for validation 21tumor sites, which correspond to the conditions for which a specific EORTC module has been produced, plus all remaining cancer types classified as "other setting".
The study will take place during two planned visits, one the first the day of enrollment, the second after 3-6 weeks. Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties:
* EORTC Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available.
* the Hospital Anxiety and Depression Scale (HADS)
* The Patients' Global Impression of Change (PGIC) Scale
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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PRO-CTCAE items
Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties:
* the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available.
* the Hospital Anxiety and Depression Scale (HADS)
* The Patients' Global Impression of Change (PGIC) Scale.
Eligibility Criteria
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Inclusion Criteria
•≥18 years of age.
* Female or male
* With at least two planned clinic visits (a return visit within 3-6 weeks) to avoid the need of extra visits
* Actively receiving treatment for cancer (going to receive the second or further cycle)
* Any ECOG performance status (PS)
* Able to complete questionnaire by themselves or with assistance, by using a tablet
* Able to speak and understand Italian
* Providing informed written consent
Exclusion Criteria
* Having received more than 5lines of therapies
* Currently participating in other trials which imply the completion of Patient Reported Outcomes (PROs) in the same period
* Other important acute medical conditions.
18 Years
ALL
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Francesco Perrone, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Locations
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Oncologia Medica per la Patologia Toracica- IRCCS Giovanni Paolo II
Bari, , Italy
U.O.C. Oncologia Medica - Ospedale Senatore Antonio Perrino
Brindisi, , Italy
Azienda Ospedaliero Universitaria di Cagliar
Cagliari, , Italy
Oncologia Medica 2 - IRCCS AOU San Martino
Genova, , Italy
Oncologia - A.O. Cardinale G. Panico
Lecce, , Italy
Oncologia Medica - AO Vito Fazzi
Lecce, , Italy
Oncologia Medica, Istituto Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
A.O.Ospedali Riuniti Papardo Piemonte U.O.C. di Oncologia Medica
Messina, , Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milan, , Italy
Ginecologia e Ostetricia - IRCCS Ospedale San Raffaele
Milan, , Italy
Oncologia - ASST Rhodense - Presidio di Garbagnat
Milan, , Italy
Oncologia - ASST Rhodense - Presidio di Rho
Milan, , Italy
Istituto Nazionale Tumori, Dip. Uro-Ginecologico S.C. Oncologia Clinica Sperimentale Uro-Ginecologica
Naples, , Italy
Oncologia Medica Toraco-Polmonare -Istituto Nazionale Tumori
Naples, , Italy
Servizio di Oncologia Medica ed Ematologia - DAI di Internistica Polispecialistica- AOU Università degli studi della Campania "Luigi Vanvitelli"
Naples, , Italy
Struttura semplice Sarcomi ossa e tessuti molli, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
Naples, , Italy
U.O.C. di Oncologia - Presidio Monaldi - AORN Ospedale dei Colli
Napoli, , Italy
Istituto Oncologico Veneto
Padua, , Italy
AOU Oncologia Medica
Parma, , Italy
Oncologia traslazionale - ICS Maugeri di Pavia
Pavia, , Italy
Oncologia Medica ed Ematologia, USL di Piacenza - Ospedale Guglielmo da Saliceto
Piacenza, , Italy
Oncologia Medica 2 - Istituto Nazionale Tumori "Regina Elena"
Roma, , Italy
UOC Oncologia Medica 1 - Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena
Roma, , Italy
Oncologia - Ospedale S. G. Moscati
Taranto, , Italy
Oncologia Medica - Istituto Sacro Cuore Don Calabria
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Domenico Galetta, MD
Role: primary
Saverio Cinieri, MD
Role: primary
Alberto Sobrero, MD
Role: primary
Lucia Del Mastro, MD
Role: primary
Emiliano Tamburini, MD
Role: primary
Silvana Leo, MD
Role: primary
Ugo De Giorgi, MD, PhD
Role: primary
Vincenzo Adamo, MD
Role: primary
Carla Ida Ripamonti, MD
Role: primary
Alice Bergamini, MD
Role: primary
Silvia Della Torre, MD
Role: primary
Sara Di Bella, MD
Role: primary
Sandro Pignata, MD, PhD
Role: primary
Alessandro Morabito, MD
Role: primary
Michele Orditura, MD
Role: primary
Antonio Pizzolorusso, MD
Role: primary
Vittorina Zagonel, MD
Role: primary
Marcello Tiseo, MD
Role: primary
Camillo Porta, MD
Role: primary
Luigi Cavanna, MD
Role: primary
Patrizia Vici, MD
Role: primary
Antonella Savarese, MD
Role: primary
Salvatore Pisconti, MD
Role: primary
Stefania Gori, MD
Role: primary
References
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Caminiti C, Maglietta G, Arenare L, Di Liello R, Migliaccio G, Barberio D, De Laurentiis M, Di Rella F, Nuzzo F, Pacilio C, Iodice G, Orditura M, Ciardiello F, Di Bella S, Cavanna L, Porta C, Giovanardi F, Ripamonti CI, Bilancia D, Aprile G, Ruelle T, Diodati F, Piccirillo MC, Iannelli E, Pinto C, Perrone F. Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE(R)) in breast cancer patients: The prospective observational multicenter VIP study. Breast. 2024 Oct;77:103781. doi: 10.1016/j.breast.2024.103781. Epub 2024 Jul 20.
Other Identifiers
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VIP
Identifier Type: -
Identifier Source: org_study_id
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